The following data is part of a premarket notification filed by Ace Surgical Supply Co., Inc. with the FDA for Ace Ha Screw Dental Implant System.
| Device ID | K021244 |
| 510k Number | K021244 |
| Device Name: | ACE HA SCREW DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. Brockton, MA 02301 |
| Contact | J Edward Carchidi |
| Correspondent | J Edward Carchidi ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. Brockton, MA 02301 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-19 |
| Decision Date | 2002-05-03 |