(29 days)
The Hex-Lock Short Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. It can be used for a single or multiple-unit restoration.
The Short Healing Cap 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, and to prevent material from lodging in any undercuts or openings.
The Short Provisional Coping is used for fabricating a cement-retained provisional restoration for a Short Hex-Lock Abutment. Use of the provisional coping is not to exceed 28 days.
The new abutments have a prepared margin and cone shape. A prepared margin and cone shape top portion and an apex with a hex configuration with 1 degree tapered flats. . The taper on the cone of the abutment is 3 degrees. The cone of the abutment has a flat section for anti-rotation.
The Healing Cap is made to precisely fit the abutment for placement on the Abutment at the time of placement to protect the soft tissue during the healing process.
The provisional coping is made to precisely fit the abutments to allow for the placement of a provision crown on the abutment.
This document is a 510(k) Pre-Market Notification for a medical device (Hex-Lock Short Abutment, Short Healing Cap, Short Provisional Coping). It does not contain information about the acceptance criteria or a study proving the device meets those criteria.
The 510(k) summary (pages 0-1) describes:
- Submitter's Information: Zimmer Dental Inc.
- Device Name: Hex-Lock Short Abutment, Short Healing Cap, Short Provisional Coping
- Device Classification Name: Endosseous Dental Implant Abutment
- Predicate Device(s): Zimmer® Dental 3.5mm Hex-Lock Abutment (HLA3/3), Zimmer® Contour Healing Cap, Zimmer Contour Provisional Coping.
- Device Description: The new abutments have a prepared margin and cone shape, a hex configuration with 1-degree tapered flats, and a 3-degree cone taper with a flat section for anti-rotation. The healing cap and provisional coping are designed to precisely fit the abutments.
- Intended Use: (page 1)
- Hex-Lock Short Abutment: Terminal or intermediate abutment for a cemented prosthesis (single or multiple-unit restoration).
- Short Healing Cap: Used with the Short Hex-Lock Abutment to prevent soft tissue irritation and material lodging during healing.
- Short Provisional Coping: Used for fabricating a cement-retained provisional restoration for a Short Hex-Lock Abutment, not to exceed 28 days of use.
- Device Comparison: (page 1) The new devices are described as "equivalent in design with Predicates" and "dimensional modifications" (shorter in overall height) to previously cleared devices. Materials, general structure, and function remain the same.
The FDA letter (pages 2-3) confirms the clearance of the device based on substantial equivalence to predicate devices, subject to general controls and applicable specific controls.
The "Indications for Use" form (page 4) reiterates the intended uses as described above.
Therefore, based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. This type of information (specific performance data, acceptance criteria, details of a clinical or non-clinical study) is typically found in the full 510(k) submission, not necessarily in the publicly available 510(k) summary or determination letter. The document explicitly states this is a "Special 510(k): Device Modification" and relies on substantial equivalence to predicate devices, implying that extensive new performance studies with acceptance criteria might not have been required beyond demonstrating that the modifications do not raise new questions of safety or effectiveness.
§ 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.)