The following data is part of a premarket notification filed by Ace Surgical Supply Company Inc. with the FDA for Ace Trimark Tricam Dental Implant.
Device ID | K103790 |
510k Number | K103790 |
Device Name: | ACE TRIMARK TRICAM DENTAL IMPLANT |
Classification | Implant, Endosseous, Root-form |
Applicant | ACE SURGICAL SUPPLY COMPANY INC. 1034 PEARL ST. Brockton, MA 02401 |
Contact | Denise Williams |
Correspondent | Denise Williams ACE SURGICAL SUPPLY COMPANY INC. 1034 PEARL ST. Brockton, MA 02401 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-12-27 |
Decision Date | 2011-08-18 |
Summary: | summary |