The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Premier Promax Bite Guard.
| Device ID | K941856 |
| 510k Number | K941856 |
| Device Name: | PREMIER PROMAX BITE GUARD |
| Classification | Block, Bite |
| 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 | JXL |
| CFR Regulation Number | 882.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-15 |
| Decision Date | 1995-04-05 |