Clinical Research Associates
Listing of FDA Cleared Products as of 10/04/99
The FDA requires that a reduction in microbial titers be effected by the unit or product before it can be cleared.
The less than 200 cfu/ml is an ADA goal.
*Information provided by the manufacturer and not confirmed by the FDA as of October '99
| Product Name | Manufacturer | 510k Number | CRA Tested | Product Appearance (Photos of products being generated) |
| A-Dec Self-Contained Water System | A-Dec Inc. | K962665 | Yes |  |
| Bacstop Dental Anti-Retraction Check Valve | Scitech Dental Inc. | K960556 | Yes | |
| Bio2000 | Micrylium | K973765 | Yes |  |
| Bioclean Concentrate | Waggoner Dental Manufacturer | K981565 | No | |
| Clearline Plus Dental Waterline Filter | Scitech Dental Inc. | K973996 | Yes |  |
| CM-11 CM-1 Water Unit | Green River Inc. | K863021 | No | |
| DCI Water Purifier | Dental Components, Inc. | K971727 | In Progress | |
| Delivery Pump for Sterile Irrigant and Handpiece | Aseptico Inc. | K8882526 [sic] |
No | |
| Dental Operative Unit Accessories | DCI International | K944271 | No | |
| DP1 | DentaPure | K963548 | Yes |  |
| DP2 | DentaPure | *K963548 | No | |
| DP40 | DentaPure | *K992868 | No | |
| DP90 | DentaPure | *K992893 | No | |
| DP365 | DentaPure | *K992893 | No | |
| Dual Air/Water Filter Cartridge Handle Kit | Q.C. Filter Inc. | K940599 | No | |
| IGN 500 Water Cleaning Unit with Calbenium | Ariel West | K964271 | Yes | |
| Infection Control Cartridge | Dentalpure | K964942 | No | |
| Nu-Valve | Bruce K. Bartlett, DDS | K950678 | No | |
| Odyssey I Dental Water Unit | Germiphene corp. | K964796 | Yes |  |
| Modification
of Odyssey I (addition of silver catalyst) |
Germiphene Corp. | K983847 | Yes | |
| Pall Dental Filtration System | Pall Medical | K983735 | No | |
| Porta-Pure Dental | Water Solutions Technologies | K961409 | No | |
| Porta-Purge w/ Bio2000 | Micrylium | K973765 | Yes |  |
| Pure Co. Fluid Delivery System | Pure Company | K971278 | Yes | |
| SBP Dental Unit | Northland Dental Engineering | K934436 | Yes | |
| Spirit II and Spirit Treatment Center | Pelton and Crane Co. | K946187 | No | |
| Sterile Water Pump | Micro Motors Inc. | K970002 | Yes | |
| Sterile Water System | Syntex Dental Products | K823230 | No | |
| The Scitech
One-Day Filter |
Scitech Dental Inc. | K930144 | Yes | |
| Sterilex Ultra | The Sterilex Corp. | K991946 | Yes |  |
| Waggoner Dental Manufacturer Steriwater System | Waggoner Dental Manufacturer | K925829 | Yes |  |
| Water Purifier for Dental Treatment | Pelton and Crane Co. | K901672 | No | |
| WKR 1 Water Delivery | Hygeniclear | K990479 | No |
The FDA requires that a reduction in microbial titers be effected by the unit or product before it can be cleared.
The less than 200 cfu/ml is an ADA goal.
*Information provided by the manufacturer and not confirmed by the FDA as of October '99
Go to results of CRA testing of above listed products.
Return to the Dental Unit Water Menu