The following data is part of a premarket notification filed by American Dental Implant Corporation with the FDA for American Dental Implant Abutment System.
| Device ID | K080397 |
| 510k Number | K080397 |
| Device Name: | AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | AMERICAN DENTAL IMPLANT CORPORATION 2415 WILMINGTON RD. New Castle, PA 16105 |
| Contact | Gina Hennon |
| Correspondent | Gina Hennon AMERICAN DENTAL IMPLANT CORPORATION 2415 WILMINGTON RD. New Castle, PA 16105 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-13 |
| Decision Date | 2008-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D8963CS0 | K080397 | 000 |
| D896TH35030 | K080397 | 000 |
| D896TH35050 | K080397 | 000 |
| D896TH3545030 | K080397 | 000 |
| D896TH3545050 | K080397 | 000 |
| D896TH45030 | K080397 | 000 |
| D896TH45050 | K080397 | 000 |
| D896TH4555030 | K080397 | 000 |
| D896TH4555050 | K080397 | 000 |
| D896TH5765030 | K080397 | 000 |
| D896TH5765050 | K080397 | 000 |
| D896TH30050 | K080397 | 000 |
| D896TH30030 | K080397 | 000 |
| D8966CS0 | K080397 | 000 |
| D896CS0 | K080397 | 000 |
| D896GPH350 | K080397 | 000 |
| D896GPH35N0 | K080397 | 000 |
| D896GPH450 | K080397 | 000 |
| D896GPH45N0 | K080397 | 000 |
| D896GPH570 | K080397 | 000 |
| D896PTA350 | K080397 | 000 |
| D896PTA450 | K080397 | 000 |
| D896TH30020 | K080397 | 000 |
| D896WDCS0 | K080397 | 000 |
| D892DBS35036 | K080397 | 000 |
| D896AB15300 | K080397 | 000 |
| D896DBS45020 | K080397 | 000 |
| D896DBS45030 | K080397 | 000 |
| D896DBS45040 | K080397 | 000 |
| D896DBS45060 | K080397 | 000 |
| D896ORS35010 | K080397 | 000 |
| D896ORS35020 | K080397 | 000 |
| D896ORS35030 | K080397 | 000 |
| D896ORS35040 | K080397 | 000 |
| D896ORS35050 | K080397 | 000 |
| D896ORS45010 | K080397 | 000 |
| D896DBS45010 | K080397 | 000 |
| D896DBS35060 | K080397 | 000 |
| D896AB15350 | K080397 | 000 |
| D896AB15450 | K080397 | 000 |
| D896AB25350 | K080397 | 000 |
| D896AB300 | K080397 | 000 |
| D896AB350 | K080397 | 000 |
| D896AB35450 | K080397 | 000 |
| D896AB450 | K080397 | 000 |
| D896AB45550 | K080397 | 000 |
| D896AB57650 | K080397 | 000 |
| D896DBS35040 | K080397 | 000 |
| D896ORS45020 | K080397 | 000 |