# K171922: Anatotemp Anatomic Dental Implant Healing Abutment

- Pathway: 510(k) (Traditional)
- Applicant: Buckeye Medical Technologies, LLC
- Decided: Sep 28, 2017 after 93 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K092377 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112099: Contour Healer, Contour Healer, LLC (2012) Summary page 4.

## Indications for use
The Anatotemp Anatomic Dental Implant Healing Abutment is a pre-manufactured healing abutment intended for use with endosseous root-form dental implants to aid in prosthetic rehabilitation. The abutment is a temporary device that aids in creating an esthetic emergence through the gingiva during the healing period. The single use, sterilized device is used by dental professionals during the dental implant healing process and is removed prior to permanent prosthetic placement. Anatotemp Anatomic Dental Implant Healing Abutments are compatible with the following implant systems: Implant Direct Legacy — 3.5mmD, 4.5mmD, 5.7mmD Implant Direct ReActive — 3.5mmD, 4.3mmD, 5.0mmD Implant Direct RePlus — 3.5mmD, 4.3mmD, 5.0mmD Implant Direct RePlant — 3.5mmD, 4.3mmD, 5.0mmD, 6.0mmD Implant Direct SwishPlus — 4.8mmD, 6.5mmD Implant Direct InterActive — 3.0mmD, 3.4mmD Implant Direct SwishActive — 3.0mmD, 3.4mmD Blue Sky Bio Quattro — Regular Platform (RP)

Source page: https://510kreport.com/device/K171922
Methodology: https://510kreport.com/methodology