CERA ONE ABUTMENT SYSTEM

K961737 · Nobelpharma USA, Inc. · DZE · Jul 10, 1996 · Dental

Device Facts

• Record ID: K961737
• Device Name: CERA ONE ABUTMENT SYSTEM
• Applicant: Nobelpharma USA, Inc.
• Product Code: DZE · Dental
• Decision Date: Jul 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nobelpharma CeraOne Abutment System is intended to be used to anchor single tooth prostheses in partially edentulous patients.

Device Story

Abutment system for endosseous dental implants; allows cementation of single tooth prostheses directly to abutment; eliminates need for additional screw connection. Modifications include dimensional changes to abutment base/external diameters and abutment screw diameters to fit broader range of previously cleared fixtures. Used by dental professionals in clinical settings to restore missing teeth.

Clinical Evidence

No clinical data provided; substantial equivalence based on identical technological characteristics and minor dimensional modifications to a previously cleared predicate.

Technological Characteristics

Endosseous dental abutment system; titanium/ceramic construction (implied by system type); dimensional variations in base and screw diameters; mechanical connection to endosseous implants; non-sterile/sterile (implied by dental standard practice).

Indications for Use

Indicated for partially edentulous patients requiring single tooth prostheses anchored to endosseous implants in the upper or lower jaw.

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

• CeraOne Abutment System (K910611)

Submission Summary (Full Text)

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K961737
JUL 10 1996

Pre-Market Notification
May 1, 1996
Page 2

## 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]. The contact person will be the Director, Regulatory Affairs. This summary was prepared on May 1, 1996.

### B. Name of the Device

This device is known as an abutment to an endosseous implant with the trade name BRÅNEMARK SYSTEM® CeraOne Abutment System. This submission is a modification to a previously cleared device under K910611.

### C. The Predicate Product

The predicate product used in this Premarket Notification is the previous version of the same device, CeraOne Abutment System, K910611.

### D. Description of the Device

The Nobelpharma CeraOne Abutment System is an abutment used with an endosseous implant which is implanted in the upper or lower jaw bone. The CeraOne System allows the prosthesis to be cemented directly to the abutment rather than requiring an additional screw connection. The modifications to the device are the broadening and narrowing of the base and external diameters of the abutments; and broadening and narrowing of the diameters of the abutment screws, adding two series of abutments fitting to larger and smaller diameters of fixtures previously cleared.

### E. Intended Use of the Device

The Nobelpharma CeraOne Abutment System is intended to be used to anchor single tooth prostheses in partially edentulous patients.

### F. Comparison of Technological Characteristics

The technological characteristics between the modified version of the CeraOne Abutment and the earlier version are identical. The only changes are minor dimensional changes to the diameter of the abutment base and the abutment screw.