# K061043: Zimmer Contour Restorative System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Dental, Inc.
- Decided: Jun 27, 2006 after 74 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Zimmer Dental Advent® Implant Extender/ Healing Collar: named in the summary without a submission number
- (no number) 3i EP Two Piece Healing Abutment: named in the summary without a submission number
- (no number) Lifecore Quick-Abutment Temporary/ Healing Cap: named in the summary without a submission number
- (no number) Zimmer Dental Pure Form Ceramic Coping: named in the summary without a submission number

## Most influential descendants
- K090723: Hex-Lock Short Abutment, Model SA341, SA342, SA451, SA452, SA561, SA562 Short Healing Cap, Model SAHEAL4, SAHEAL5, (2009), 1 descendant of its own
- K113092: Zimmer Contour Provisional Coping (2012), 0 descendants of its own

## Indications for use
The Zimmer® Contour Healing Collar is used to shape the gingival tissue during healing to allow for a suitable emergence profile of the prosthesis. The Zimmer® Contour Healing Cap is for use with a Hex-LockTM Contour Abutment or a Zimmer® One-Piece Implant to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, and to prevent material from lodging in any undercuts or openings. The Zimmer® Contour Provisional Coping is used for fabricating a provisional restoration for a Hex-LockTM Contour Abutment or a Zimmer® One-Piece Implant. Use of the provisional coping is not to exceed 28 days.

Source page: https://510kreport.com/device/K061043
Methodology: https://510kreport.com/methodology