The following data is part of a premarket notification filed by Ace Surgical Supply Co., Inc. with the FDA for Ace Basic Dental Implant Pack Ii.
| Device ID | K922649 |
| 510k Number | K922649 |
| Device Name: | ACE BASIC DENTAL IMPLANT PACK II |
| Classification | Unit, Operative Dental |
| Applicant | ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. P.O. BOX 1710 Brockton, MA 02403 |
| Contact | Joao R Quintino |
| Correspondent | Joao R Quintino ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. P.O. BOX 1710 Brockton, MA 02403 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-03 |
| Decision Date | 1994-01-10 |