# K113092: Zimmer Contour Provisional Coping

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Dental, Inc.
- Decided: Jan 23, 2012 after 96 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 K953101 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061043: Zimmer Contour Restorative System, Zimmer Dental, Inc. (2006) Summary page 1.
- K090723: Hex-Lock Short Abutment, Model SA341, SA342, SA451, SA452, SA561, SA562 Short Healing Cap, Model SAHEAL4, SAHEAL5,, Zimmer Dental, Inc. (2009) Summary page 2.
- K092377: Plastic Temporary Abutments, Models: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S, Zimmer Dental, Inc. (2009) Summary page 2.

## Indications for use
The Zimmer Contour Provisional Coping is for use with a Hex-Lock 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, to prevent material from lodging in any undercuts or openings, and for fabricating a cement-retained provisional restoration. Use of the provisional coping is not to exceed 180 days. The Short Provisional Coping is for use with a Short Hex-Lock Abutment to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, to prevent material from lodging in any undercuts or openings, and for fabricating a cement-retained provisional restoration. Use of the provisional coping is not to exceed 180 days.

Source page: https://510kreport.com/device/K113092
Methodology: https://510kreport.com/methodology