The following data is part of a premarket notification filed by Alpine Dental Equipment Co. with the FDA for Manta Dental Chair.
| Device ID | K854644 |
| 510k Number | K854644 |
| Device Name: | MANTA DENTAL CHAIR |
| Classification | Chair, Dental, With Operative Unit |
| Applicant | ALPINE DENTAL EQUIPMENT CO. 325 ELMWOOD AVE. East Orange, NJ 07018 |
| Contact | Norman Smith |
| Correspondent | Norman Smith ALPINE DENTAL EQUIPMENT CO. 325 ELMWOOD AVE. East Orange, NJ 07018 |
| Product Code | KLC |
| CFR Regulation Number | 872.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-19 |
| Decision Date | 1986-01-23 |