The following data is part of a premarket notification filed by Ace Surgical Supply Co., Inc. with the FDA for Ace Srew Dentla Implant System.
Device ID | K954513 |
510k Number | K954513 |
Device Name: | ACE SREW DENTLA IMPLANT SYSTEM |
Classification | Implant, Endosseous, Root-form |
Applicant | ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. P.O. BOX 1710 Brockton, MA 02403 |
Contact | J. Edward Carchidi |
Correspondent | J. Edward Carchidi ACE SURGICAL SUPPLY CO., INC. 1034 PEARL ST. P.O. BOX 1710 Brockton, MA 02403 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-09-28 |
Decision Date | 1996-06-05 |