ADVANTAGES AND DISADVANTAGES OF
Dental Unit Water Line Products Tested By CRA

Key:
  
  : Cleared by the FDA for use in other, non-dental applications.
  : Product cleared by the FDA and met the ADA goal.
*
 :Continual use of the same disinfectant active ingredient in dental unit waterlines over a long period of time may cause microbial resistance to develop. Therefore, it would be prudent to change the active ingredent used to disinfect the dental unit waterlines several times a year. More data are needed on this subject, since many different disinfectants yielding only partial kill are now being used routinely in dental unit waterlines.
**
 :Product is a service and not a product to lower organism counts in the dental unit waterlines, and therefore not regulated by the FDA.

Disinfectant Manufacturer Met ADA Goal FDA Cleared for Dental Unit Waterline Use Advantages
Disadvantages
Bio-2000
(0.12% Chlorhexidine Gluconate, 12% Ethanol)		 Micrylium Laboratories Yes Yes (K973765) Ready to use. Taste & odor similar to mouthrinse.
Unpleasant if ingested accidentally.
Leaves sticky, oily residue. Expensive.
Potential for allergic reaction from some patients.
Resistant organisms may develop*. Disinfection can fail without clinician knowledge.
Clorox 1:10
(30 minutes/weekly)		 Clorox Company Yes No Inexpensive.
Readily available.
Pungent odor & bitter taste.
Requires mixing.
Unpleasant if ingested accidentally.
Corrodes metals & degrades lines, bleaches carpets, clothing, etc.
Resistant organisms may develop*.
Cannot color as an indicator.
Disinfection can fail without clinician knowledge.
Clorox 1:10
(overnight/daily)		 Clorox Company Yes No Inexpensive.
Readily available.
Pungent odor & bitter taste. Requires mixing. Unpleasant if ingested accidentally.
Corrodes metals & degrades lines, bleaches carpets, clothing, etc.
Resistant organisms may develop*.
Cannot color as an indicator.
Disinfection can fail without clinician knowledge.
Clorox 1:10
(30 minutes/daily)		 Clorox Company Yes No Inexpensive.
Readily available.
Pungent odor & bitter taste.
Requires mixing.
Unpleasant if ingested accidentally.
Corrodes metals & degrades lines, bleaches carpets, clothing, etc.
Resistant organisms may develop*.
Cannot color as an indicator.
Disinfection can fail without clinician knowledge.
Chlorhexidine Gluconate, 0.4% (HibiClens 1:10) Zeneca No No Product already
in office.
Pungent odor & bitter taste.
Unpleasant if ingested accidentally.
Expensive.
Mixing required.
Resistant organisms may develop*.
Disinfection can fail without clinician knowledge.
Chlorhexidine Gluconate, 1% (HibiClens 1:4) Zeneca Yes No Product already
in office.
Pungent odor & bitter taste.
Unpleasant if ingested accidentally. Expensive.
Mixing required.
Resistant organisms may develop*.
Disinfection can fail without clinician knowledge.
Ethanol, 95% (Grain Alcohol/Everclear) Liquor Store No No Used for human consumption.
Ready to use.
Pungent odor & bitter taste.
Unpleasant if ingested accidentally.
Expensive.
Mixing required.
Resistant organisms may develop*.
Disinfection can fail without clinician knowledge.
Ethanol, 80% (Grain Alcohol/Everclear) Liquor Store No No Used for human consumption.
Ready to use.
Pungent odor & bitter taste.
Unpleasant if ingested accidentally.
Expensive.
Mixing required.
Resistant organisms may develop*.
Disinfection can fail without clinician knowledge.
Glutaraldehyde, 2% (MaxiCide and OmniCide) Baxter/Schein Yes No Product already
in office.
Foams after purging.
Pungent odor & bitter taste.
Requires mixing.
Unpleasant if ingested accidentally.
Resistant organisms may develop*.
Disinfection can fail without clinician knowledge.
Rembrandt Mouthrinse DenMat No No Over the counter product.
Ready to use.
Pleasant taste. Readily available.
Expensive.
Resistant organisms may develop*.
Disinfection can fail without clinician knowledge.
Scope Mouthrinse 1:11 Proctor & Gamble Yes No Over the counter product.
Ready to use. Pleasant taste. Readily available.
Expensive.
Resistant organisms may develop*.
Disinfection can fail without clinician knowledge.
Sterilex Ultra The Sterilex Corp. Yes Yes (K991946) Quick and easy to use. Easy to mix.
Mixing required.
Observed increase in microbial counts after ~20 weeks of use.
Resistant organisms may develop*.
Disinfection can fail without clinician knowledge.
In-Line Filter(s) Systems Manufacturer Met ADA Goal FDA Cleared for Dental Unit Waterline Use Advantages
Disadvantages
Bacstop Dental Anti-Retraction Check Valve (Clearline/Bacstop) Scitech Dental Inc. Yes Yes (K960556) Easy filter change. Filter is in-line. Small in size.
Expensive. Needs to be changed daily. Services only one waterline per filter. Can fail without clinician knowledge.
DentaPure DP1 DentaPure Yes Yes (K963548) Filter is in-line. Small in size.
Possible patient allergic reaction to iodine. Expensive. Needs to be changed about every three days. Filter may clog. Need to cut line to install. Services only one waterline per filter. Can fail without clinician knowledge.
FiberFlo M-I-200-A
w/ Actril		 Fibercor Yes No for Dental Units, Yes for Dialysis: Filter (K983126) Actril (K861730) Filter is in-line. Small in size. Maintenance is simple. One filter cartridge services all waterlines for operatory.

Actril disinfectant solution very acidic, which has the potential to cause the patient harm.
Time to flush from lines prohibitive.
Filter can fail without clinician knowledge.
Sci-Tech One-Day Filter
(Clearline Adapter)		 Scitech Dental Inc. Yes Yes (K930144) Easy filter change. Filter is in-line. Small in size.

Expensive.
Needs to be changed daily.
Services only one waterline per filter.
Disinfection can fail without clinician knowledge.
Purge Systems Manufacturer Met ADA Goal FDA Cleared for Dental Unit Waterline Use Advantages
Disadvantages
Air Purge Unit Flatland Dental Products No No Maintenance is simple. Unit is "in-line." Small in size.
Water continues to leave waterlines after
15 minutes of purging. Disinfection can fail without clinician knowledge.
Porta-Purge
w/Bio-2000		 Micrylium Laboratories Yes For use with Bio2000 - Yes (K973765) Portable. Easy to use. Easy to install. One unit services all the waterlines for the operatory.
Changing the disinfectant bottle awkward.
At least one week required to reduce microbes to 200 cfu/ml.
Disinfection can fail without clinician knowledge.
Independent Water Systems Manufacturer Met ADA Goal FDA Cleared for Dental Unit Waterline Use Advantages
Disadvantages
AquaSept (InterSept/SBP Dental Unit) Lares Research Yes Yes (K934436) Independent water system. Can be sterilized.
Time consuming.
Expensive.
Disinfection can fail without clinician knowledge.
Odyssey I
w/ Silver Catalyst		 Germiphene Corp./Tuttnauer Yes Yes (K983847) Minimal maintenance required. Large reservoir size.
Puts silver into the water. Expensive.
Yearly maintenance required.
Requires the use of distilled water, only. Disinfection can fail without clinician knowledge.
Pure Company Fluid Delivery System Pure Company Yes Yes (K971278) Independent water system. Two reservoirs on one unit.
Expensive.
Disinfection can fail without clinician knowledge.
Self-Contained Water System A-dec, Inc. Yes Yes (K962665) Relatively inexpensive.

Technique sensitive.
Bleach used to disinfect unit is corrosive to brass & other soft metals.
Hypochlorite bleaches clothing, carpets, etc.
Time consuming.
Bottle wears out. Disinfection can fail without clinician knowledge.
Sterile Water Pump Micro Motors/Biotrol Yes Yes (K970002) Independent water system. Components can be sterilized.
Expensive.
Disinfection can fail without clinician knowledge.
SteriWater System Waggoner Yes Yes (K925829) Entire system is sterilized.
System leaks after repeated sterilization cycles.
Disinfection can fail without clinician knowledge.
In-Line Water Systems Manufacturer Met ADA Goal FDA Cleared for Dental Unit Waterline Use Advantages
Disadvantages
Clean Source I Aquarius Technologies No No Unit is compact and attractive. Attachment of handpieces and air/water lines fairly easy. Alarm if cycle is not completed. Simple one button activation.
Installation difficult.
Adapter on air/water syringe bulky.
Water not accessible if unit malfunctions.
Disinfection can fail without clinician knowledge.
GermFree Water System GermFree Water No No Does not require daily staff maintenance. Services multiple operatories.
Need to replace bulbs yearly.
Expensive.
Disinfection can fail without clinician knowledge.
IGN 500 w/Calbenium

Athena Technology/
Ariel West

 Yes For use with Calbenium- Yes (K964271) In line system. Little staff maintenance required.
Disinfectant continuously put into lines--comes in contact with patient.
Bitter taste.
Sloughing of biofilm can clog handpiece.
Disinfection can fail without clinician knowledge.
PureMax Water Unit
(Formerly Named Parrot)		 Puremax No No Maintenance is simple. Unit is "in-line". Water contains no chemicals.
Unit heats up to 49°C. Disinfection can fail without clinician knowledge.
SAL-20
(Large Recirculating unit)		 Miox No No Maintenance is simple. No chemicals in system.
Not really set up for dental office.
Problems with leaking.
Disinfection can fail without clinician knowledge.
Monitoring Systems Manufacturer Met ADA Goal FDA Cleared for Dental Unit Waterline Use Advantages
Disadvantages
Aqua-Dent Aqua-Dent
(Formerly Sold by Lares)		 N/A No (K934436) Accurate. Quick turn around.
Expensive.
Limit of ten samples per package.
Bactipure New Jersey Laboratories N/A **N/A Can be used in office.
Messy.
Comprehensive Water Test Kit Micrylium Laboratories N/A Bio-2000 component - Yes (K973765) Accurate. Quick turn around.
Expensive.
Limit of three samples per package.
Heterotrophic Plate Count Sampler Millipore Corp. N/A **N/A Simple to use. Gives qualitative count of bacteria. Can be used in dental office.
Expensive.
Bacteria counts too low for accurate quantitative measurement.
Paddle Testers Millipore Corp. N/A **N/A Simple to use. Gives qualitative count of bacteria. Can be used in dental office.
Expensive.
Bacteria counts too low for accurate quantitative measurement.
Bacteria counts near edge of paddle compromised by pooled moisture.
Total Count Sampler Millipore Corp. N/A **N/A Simple to use. Gives qualitative count of bacteria. Can be used in dental office.
Expensive.
Bacteria counts too low for accurate quantitative measurement.
Key:
  
  : Cleared by the FDA for use in other, non-dental applications.
  : Product cleared by the FDA and met the ADA goal.
*
 :Continual use of the same disinfectant active ingredient in dental unit waterlines over a long period of time may cause microbial resistance to develop. Therefore, it would be prudent to change the active ingredent used to disinfect the dental unit waterlines several times a year. More data are needed on this subject, since many different disinfectants yielding only partial kill are now being used routinely in dental unit waterlines.
**
 :Product is a service and not a product to lower organism counts in the dental unit waterlines, and therefore not regulated by the FDA.

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