# K112099: Contour Healer

- Pathway: 510(k) (Traditional)
- Applicant: Contour Healer, LLC
- Decided: Feb 3, 2012 after 196 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: 1 generation back to K092377 (2009). 1 ancestor in all.
21 later devices descend from it; 2 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092377: Plastic Temporary Abutments, Models: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S, Zimmer Dental, Inc. (2009) Summary page 2.

## Most influential descendants
- K120793: Z-LOOK3 Evo SLM (2012), 19 descendants of its own
- K151328: PURE Ceramic Implants (2016), 12 descendants of its own
- K171769: Straumann PURE Ceramic Implants (2017), 8 descendants of its own
- K132881: Z5C (2014), 8 descendants of its own
- K180477: Straumann PURE Ceramic Implant System (2019), 6 descendants of its own

## Indications for use
The Contour Healer Temporary Abutment is intended for use with a root-form endosseous dental abutment to aid in prosthetic rehabilitation. The abutment is a provisional restoration that aids in creating an esthetic emergence through the gingiva during the healing period. The device is for use by dental professionals for single restorations in adults. The device is for single-use only and may not be re-processed. These abutments are designed to work with the following implant systems: Zimmer [Screw-Vent Dental Implant System] Nobel Biocare [Replace HA Coated Implant, Replace TiUnite Endosseous Implant, Nobel Biocare Endosseous Implants, and Groovy Implants] BioHorizons [BioHorizons Tapered Internal Implant System].

Source page: https://510kreport.com/device/K112099
Methodology: https://510kreport.com/methodology