The following data is part of a premarket notification filed by Dental Components, Inc. with the FDA for Dci Water Purifier.
| Device ID | K971727 |
| 510k Number | K971727 |
| Device Name: | DCI WATER PURIFIER |
| Classification | Unit, Operative Dental |
| Applicant | DENTAL COMPONENTS, INC. 305 NORTH SPRINGBROOK RD. Newberg, OR 97132 -0228 |
| Contact | Richard W Hanson |
| Correspondent | Richard W Hanson DENTAL COMPONENTS, INC. 305 NORTH SPRINGBROOK RD. Newberg, OR 97132 -0228 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-09 |
| Decision Date | 1997-09-12 |