The following data is part of a premarket notification filed by Advantage Dental Co. with the FDA for Occlusal Harmony Impression Tray.
| Device ID | K884316 |
| 510k Number | K884316 |
| Device Name: | OCCLUSAL HARMONY IMPRESSION TRAY |
| Classification | Tray, Impression, Preformed |
| Applicant | ADVANTAGE DENTAL CO. 3051 E. PONTIAC RD. Auburn Hills, MI 48057 |
| Contact | J Pelerin,dds |
| Correspondent | J Pelerin,dds ADVANTAGE DENTAL CO. 3051 E. PONTIAC RD. Auburn Hills, MI 48057 |
| Product Code | EHY |
| CFR Regulation Number | 872.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-13 |
| Decision Date | 1988-12-22 |