ABUTMENT SELECTION KIT

K960639 · Nobelpharma USA, Inc. · DZE · May 14, 1996 · Dental

Device Facts

• Record ID: K960639
• Device Name: ABUTMENT SELECTION KIT
• Applicant: Nobelpharma USA, Inc.
• Product Code: DZE · Dental
• Decision Date: May 14, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Intended Use

The Nobelpharma BRÄNEMARK SYSTEM® Abutment Selection Kit is intended to be used by practitioners to select the proper abutment.

Device Story

Kit contains trial models of various abutments; used by clinicians to select proper abutment type and length. Application: patient's mouth (5-10 minutes) or on plaster models. Output: physical selection of correct abutment for long-term use. Benefit: facilitates accurate clinical fit for dental implant procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Trial abutments; colorant method used for visual distinction from long-term abutments. Identical to predicate device.

Indications for Use

Indicated for use by dental practitioners to determine the appropriate type and length of abutments for patients requiring dental implant restorations.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• Abutment selection kit (K944963)

Submission Summary (Full Text)

{0}

K960639

Pre-Market Notification
February 7, 1996
Page -2-

MAY 14 1996

## VI. 510(k) Summary of Safety and Effectiveness

### A. Name and Address

This Summary of Safety and Effectiveness is being submitted by Nobelpharma USA, Inc., 777 Oakmont Lane, Suite 100, Westmont, IL 60559. Their telephone number is: [phone] and the contact person will be the Director, Regulatory Affairs. This summary was prepared on February 7, 1996.

### B. Name of the Device

The device is generally known as trial model abutments used for fitting purposes, and will have the trade name "BRÄNEMARK SYSTEM® Abutment Selection Kit."

### C. The Predicate Product

The predicate products used in this Premarket Notification is the abutment selection kit, K944963.

### D. Description of the Device

The Nobelpharma BRÄNEMARK SYSTEM® Abutment Selection Kit consists of trial models of various abutments which are used by the practitioner to select the proper abutment. It can be used in two situations: in a patient’s mouth and/or on a plaster model. The abutment selection system is used in a patient’s mouth for only 5-10 minutes so that the clinician can determine the proper abutment type and length.

### E. Intended Use of the Device

The Nobelpharma BRÄNEMARK SYSTEM® Abutment Selection Kit is intended to be used by practitioners to select the proper abutment.

### F. Comparison of Technological Characteristics

The technological characteristics between the two Abutment Selection Kits are identical. The proposed colorant method is used to provide a bright color distinction between the "trial" abutments and the abutments intended for long-term use.