ANGLED ABUTMENT

K962647 · Straumann USA · DZE · Oct 7, 1996 · Dental

Device Facts

• Record ID: K962647
• Device Name: ANGLED ABUTMENT
• Applicant: Straumann USA
• Product Code: DZE · Dental
• Decision Date: Oct 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Intended Use

The modified angled abutment is indicated to be used in cases where the angle of placement of the implant requires an angled reconstruction for an aesthetic result. The abutment can be used to restore both crowns for single tooth replacements and bridges for bound situations.

Device Story

ITI Angled Abutment serves as interface between endosseous dental implant and prosthetic restoration; provides angulation correction for aesthetic alignment. Device features 8° conical taper for implant connection; secured via basal titanium screw. Available in 15° and 20° angles. Clinician inserts abutment into implant using positioning aide for orientation; secures with screwdriver through lateral access hole. Supports both cemented and screw-retained restorations. Impression cylinder and transfer pin used for cast replication. Used in dental clinics by trained clinicians.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Commercially pure Grade 4 titanium (ASTM F67). Design: Single-piece abutment with 8° conical taper. Accessories: Anodized aluminum positioning aide (single-use), stainless steel impression cylinder and transfer pin. Energy source: None (mechanical). Connectivity: None. Sterilization: Provided non-sterile.

Indications for Use

Indicated for patients requiring dental implant prosthetic restoration where implant placement angle necessitates angled reconstruction for aesthetic outcomes; applicable for single tooth crowns and bridges in all areas of the oral cavity.

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

• ITI Angled Abutment (K941393)
• Brånemark Angled Abutment (K905434)
• Calcitek Angled Abutment
• 3i Angled Abutment

Submission Summary (Full Text)

{0}

K962647
Oct. 7, 1996

# ATTACHMENT 9 - 510(k) Summary

## 1. Applicant's Name and Address

Straumann USA (on behalf of Institut Straumann AG)
One Alewife Center, Cambridge, MA 02140-2317
Telephone Number: 617-868-3800
Fax Number: 617-868-9111
Contact Person: Amy M. Gardner, Regulatory Affairs Manager
Summary prepared: June 14, 1996

## 2. Name of the Device

Trade Name: ITI Angled Abutment
Common Name: Abutment for endosseous dental implant
Classification Name: Accessory to a dental implant (21 CFR 872.3640)

## 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices)

1. ITI Angled Abutment (K941393)
2. Brånemark Angled Abutment (K905434)
3. Calcitek Angled Abutment (K number unknown)
4. 3i Angled Abutment (K number unknown)

## 4. Description of the Device

The ITI angled abutment is placed into the dental implant to provide support for the prosthetic restoration. The subject device of this 510(k) is a modification of the ITI Angled Abutment, previously cleared by FDA under K941393 for angulation correction in the saggital plane of the anterior maxilla. The intended use of the modified angled abutment is for angulation correction in all areas of the oral cavity.

The modified angled abutment is available in 15° and 20° angles and is made from commercially pure Grade 4 titanium (cold worked) which conforms to ASTM Standard Specification F67. The abutment is provided non-sterile in medical grade heat-sealed packaging.

The basal portion of the modified angled abutment has an 8° conical taper which fits into the coronal portion of the ITI implants. The abutment is held in place with a screw located in the basal portion of the abutment. This screw is also composed of Grade 4 titanium. The abutment is manufactured out of a single piece of titanium. The screw and suspension ring are mounted into the basal portion of the abutment. The coronal aspect of the abutment has an occlusal thread for the impression coping and a lateral screwdriver access hole.

## Accessories

A positioning aide is available to be inserted into the top of the abutment to assist the clinician in properly orienting the direction of angulation upon abutment insertion. The positioning aide is removed from the abutment after the basal screw has engaged the implant. The positioning aide is composed of anodized aluminum and is for single use only. A screwdriver is required to tighten the basal screw of the abutment into the implant through a lateral access hole in the coronal portion of the

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abutment. The impression cylinder and transfer pin are composed of stainless steel. The impression cylinder is mounted into the occlusal threads on the coronal portion of the abutment when the impression is taken. The impression cylinder is then removed from the abutment and attached to the transfer pin. The impression cylinder and transfer pin are reinserted into the impression material and the cast is poured, incorporating the transfer pin and obtaining a precise replication of the abutment in the implant in the mouth. If the clinician decides to screw retain the prosthesis, as opposed to cementing, the occlusal screw is required to secure the final restoration to the abutment. The screw is composed of Grade 4 titanium. If occlusal space allows, the extension shell can be placed over the abutment to serve as an extended screw bed and screw channel for the occlusal screw.

## 5. Intended Use of the Device

The modified angled abutment is indicated to be used in cases where the angle of placement of the implant requires an angled reconstruction for an aesthetic result. The abutment can be used to restore both crowns for single tooth replacements and bridges for bound situations.

## 6. Summary of Device Compared to Predicate Devices

| | Subject Device | Predicate Devices | | | |
| --- | --- | --- | --- | --- | --- |
| | ITI Modified Angled Abutment | Previously Cleared ITI Angled Abutment | Brånemark Angled Abutment | Calcitek Angled Abutment | 3i Angled Abutment |
| Intended Use | | | | | |
| Provide support for dental prosthesis | Yes | Yes | Yes | Yes | Yes |
| For use with cemented restorations | Yes | Yes | Yes | Yes | Yes |
| For use with screw-retained restorations | Yes | Yes | No | No | No |
| Design | | | | | |
| Screwed into implant to be used as a base for dental prosthesis | Yes | Yes | Yes | Yes | Yes |
| Available degrees of angulation | 15° and 20° | 15° and 20° | 17° and 30° | 15° and 25° | 15°, 25°, and 35° |
| Composition | | | | | |
| Composed of Titanium | Yes | Yes | Yes | Yes | Yes |
| K Number | | K941393 | K905434 | unknown | unknown |