The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Premier Mirror Warmer.
| Device ID | K945395 |
| 510k Number | K945395 |
| Device Name: | PREMIER MIRROR WARMER |
| Classification | Unit, Examining/treatment, Ent |
| Applicant | PREMIER DENTAL PRODUCTS CO. 10090 SANDMEYER LN. Philadelphia, PA 19116 -3502 |
| Contact | William J Frezel |
| Correspondent | William J Frezel PREMIER DENTAL PRODUCTS CO. 10090 SANDMEYER LN. Philadelphia, PA 19116 -3502 |
| Product Code | ETF |
| CFR Regulation Number | 874.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-03 |
| Decision Date | 1995-01-18 |