TITANIUM HEALING CAPS

K960634 · The Straumann Co. · DZE · Jun 18, 1996 · Dental

Device Facts

• Record ID: K960634
• Device Name: TITANIUM HEALING CAPS
• Applicant: The Straumann Co.
• Product Code: DZE · Dental
• Decision Date: Jun 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Intended Use

The esthetic healing caps are intended to protect the inner configuration of the III implant and the outer 45° shoulder of the implant during the healing phase after implant placement. The esthetic healing cap also serves to maintain, form, and stabilize the soft tissue during the healing phase. The primary indication for the esthetic healing cap is in the intra-oral esthetic zone where soft tissue conditioning is essential to achieve optimal esthetic results with implant-borne restorations.

Device Story

Titanium healing caps designed for use with ITI dental implants; placed during post-surgical healing phase (6-12 weeks). Device protects implant inner configuration and 45° shoulder; maintains, forms, and stabilizes soft tissue in esthetic oral zones. Features a bevel for labial/buccal positioning to allow tension-free mucoperiosteal flap closure. Operated by dentists/oral surgeons in clinical settings. Output is physical tissue support and protection of implant components; aids clinician in achieving optimal esthetic results for subsequent restorations.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Composed of commercially pure Grade 4 titanium (ASTM F67-95). Two-part design: healing cap body and occlusal screw. Available in 2.0 mm and 3.5 mm heights. Beveled design for soft tissue flap management. Non-software device.

Indications for Use

Indicated for patients requiring dental implant soft tissue conditioning in the intra-oral esthetic zone to facilitate optimal esthetic outcomes with implant-borne restorations during the 6-12 week post-implant healing phase.

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 Large Closure Screw
• Brånemark Healing Abutments
• Steri-Oss Healing Abutments
• Implant Innovations' Healing Abutments

Submission Summary (Full Text)

{0}

K960634

# ATTACHMENT 7 - 510(k) Summary

JUN 18 1996

## 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: Ms. Carolyn M. Bitetti, Director, Regulatory Affairs
Summary prepared January 23, 1996

## 2. Name of the Device

Trade Name: ITI Esthetic Healing Caps
Common Name: Healing cap or healing abutment
Classification Name: Accessory to a dental implant (21 CFR 872.3640)

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

1. ITI Large Closure Screw
2. Brånemark Healing Abutments
3. Steri-Oss Healing Abutments
4. Implant Innovations' Healing Abutments

## 4. Description of the Device

The ITI esthetic healing caps are titanium devices which are mounted onto an ITI implant before the soft tissue is sutured in place around the implant. These healing caps are intended to protect the inner configuration of the ITI implant and the 45° outer shoulder of the implant during the healing phase after the placement of the implant. The esthetic healing caps also serve to maintain, form, and stabilize the soft tissue during the healing phase. The primary indication for the esthetic healing caps is in the esthetic zone of the oral cavity where soft tissue conditioning is essential to achieve an optimal esthetic result with implant-borne restorations. The esthetic healing cap remains in place for six to twelve weeks.

The ITI esthetic healing cap is available in two heights (2.0 mm and 3.5 mm). Each cap consists of two parts: the body of the healing cap itself and a corresponding occlusal screw which affixes the cap onto the implant. The healing caps and the occlusal screws are composed of commercially pure Grade 4 titanium meeting ASTM F67-95.

The esthetic healing caps are designed with a bevel which should be positioned either labially or bucally. This bevel enables positioning of the mucoperiosteal flap over the esthetic healing cap after implant placement without subjecting the flap to tension.

Page 53

{1}

Page 54

# 5. Intended Use of the Device

The esthetic healing caps are intended to protect the inner configuration of the III implant and the outer 45° shoulder of the implant during the healing phase after implant placement. The esthetic healing cap also serves to maintain, form, and stabilize the soft tissue during the healing phase. The primary indication for the esthetic healing cap is in the intra-oral esthetic zone where soft tissue conditioning is essential to achieve optimal esthetic results with implant-borne restorations.

# 6. Summary of Technological Characteristics of Device Compared to Predicate Devices

| Feature | Predicate Devices | | | |
| --- | --- | --- | --- | --- |
| | III Large Closure Screw | Brånemark Healing Abutments | Implant Innovations Healing Abutments | Steri-Oss Healing Abutments |
| Intended Use | | | | |
| To form, stabilize, and maintain the soft tissue. | YES | YES | YES | YES |
| Material | | | | |
| Titanium | YES | YES | YES | YES |
| Design | | | | |
| Diameters (mm) | 6.0 mm | 5.0 mm | 4.5 mm - 7.5 mm | 3.5 mm - 6.0 mm |
| Heights (mm) | 1.5 mm | 3.0 mm - 7.0 mm | 2.0 mm - 8.0 mm | 5.0 mm - 7.0 mm |
| Inserted directly into the implant during soft tissue healing period. | YES | YES | YES | YES |