The following data is part of a premarket notification filed by Syntex Dental Products, Inc. with the FDA for Sterile Water System.
| Device ID | K823230 |
| 510k Number | K823230 |
| Device Name: | STERILE WATER SYSTEM |
| Classification | Unit, Operative Dental |
| Applicant | SYNTEX DENTAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-29 |
| Decision Date | 1982-12-03 |