(74 days)
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-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, and to prevent material from lodging in any undercuts or openings.
The Zimmer® Contour Provisional Coping is used for fabricating a cement-retained provisional restoration for a Hex-Lock™ Contour Abutment or a Zimmer® One-Piece Implant. Use of the provisional cap is not to exceed 28 days.
The Zimmer Contour Restorative System is used to aid in the preparation of dental prostheses, as well as, to form the gingival tissue around an endosseous implant site prior to prosthesis fixation. The system is used with Zimmer Dental abutment-endosseous dental implant combinations, as well as, the Zimmer® One-Piece Implant. Devices are available in titanium or acrylic.
This document is a 510(k) summary for the Zimmer® Contour Restorative System, specifically for the healing collar, healing cap, and provisional coping components. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
The document discusses:
- Device identification: Zimmer® Contour Restorative System (Healing Collar, Healing Cap, Provisional Coping).
- Intended Use: Shaping gingival tissue (healing collar), preventing irritation and material lodging (healing cap), and fabricating provisional restorations (provisional coping).
- Device Description: Used with Zimmer Dental abutment-endosseous dental implant combinations and Zimmer® One-Piece Implant, available in titanium or acrylic.
- Predicate Devices: Zimmer Dental Advent® Implant Extender/Healing Collar, 3i EP Two Piece Healing Abutment, Lifecore Quick-Abutment Temporary/Healing Cap, Zimmer Dental Pure Form Ceramic Coping.
- Substantial Equivalence: Zimmer Dental Inc. believes the device is substantially equivalent to its predicates in intended use, design, and materials.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance because it is not present in the provided text. The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive de novo performance studies with specific acceptance criteria in the same way a PMA (Pre-Market Approval) process might.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)