The following data is part of a premarket notification filed by Buckeye Medical Technologies Llc with the FDA for Anatotemp Anatomic Dental Implant Healing Abutment.
| Device ID | K171922 |
| 510k Number | K171922 |
| Device Name: | Anatotemp Anatomic Dental Implant Healing Abutment |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Buckeye Medical Technologies LLC 405 Niles Cortland Rd SE Ste 202 Warren, OH 44484 |
| Contact | Terry B. Philibin |
| Correspondent | Terry B. Philibin Buckeye Medical Technologies LLC 405 Niles Cortland Rd SE Ste 202 Warren, OH 44484 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-27 |
| Decision Date | 2017-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7861035010 | K171922 | 000 |
| D7861530030 | K171922 | 000 |
| D7861530040 | K171922 | 000 |
| D7861534010 | K171922 | 000 |
| D7861534030 | K171922 | 000 |
| D7861534040 | K171922 | 000 |
| D7861534050 | K171922 | 000 |
| D7861534060 | K171922 | 000 |
| D7861544050 | K171922 | 000 |
| D7861544060 | K171922 | 000 |
| D7861530020 | K171922 | 000 |
| D7861530010 | K171922 | 000 |
| D7861057060 | K171922 | 000 |
| D7861035020 | K171922 | 000 |
| D7861035030 | K171922 | 000 |
| D7861035040 | K171922 | 000 |
| D7861045010 | K171922 | 000 |
| D7861045030 | K171922 | 000 |
| D7861045040 | K171922 | 000 |
| D7861045050 | K171922 | 000 |
| D7861045060 | K171922 | 000 |
| D7861057050 | K171922 | 000 |
| D7862035010 | K171922 | 000 |
| D7862035020 | K171922 | 000 |
| D7863048050 | K171922 | 000 |
| D7863048060 | K171922 | 000 |
| D7863065050 | K171922 | 000 |
| D7863065060 | K171922 | 000 |
| D7864041010 | K171922 | 000 |
| D7864041020 | K171922 | 000 |
| D7864041030 | K171922 | 000 |
| D7864041040 | K171922 | 000 |
| D7864048050 | K171922 | 000 |
| D7863048040 | K171922 | 000 |
| D7863048030 | K171922 | 000 |
| D7863048010 | K171922 | 000 |
| D7862035030 | K171922 | 000 |
| D7862035040 | K171922 | 000 |
| D7862043010 | K171922 | 000 |
| D7862043030 | K171922 | 000 |
| D7862043040 | K171922 | 000 |
| D7862050050 | K171922 | 000 |
| D7862050060 | K171922 | 000 |
| D7862060050 | K171922 | 000 |
| D7862060060 | K171922 | 000 |
| D7864048060 | K171922 | 000 |