The following data is part of a premarket notification filed by Safe Wave Products, Inc. with the FDA for Safe-tips Ez.
| Device ID | K951238 |
| 510k Number | K951238 |
| Device Name: | SAFE-TIPS EZ |
| Classification | Unit, Operative Dental |
| Applicant | SAFE WAVE PRODUCTS, INC. 460 B SOVEREIGN COURT Ballwin, MO 63011 -4432 |
| Contact | Bernard Esrock |
| Correspondent | Bernard Esrock SAFE WAVE PRODUCTS, INC. 460 B SOVEREIGN COURT Ballwin, MO 63011 -4432 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-20 |
| Decision Date | 1995-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6837750015 | K951238 | 000 |
| D6837720012 | K951238 | 000 |
| D683722001 | K951238 | 000 |
| D6836660014 | K951238 | 000 |
| D6836615014 | K951238 | 000 |
| D6834460010 | K951238 | 000 |
| D6834415010 | K951238 | 000 |