The esthetic healing caps are intended to protect the inner configuration of the M 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 fissue conditioning is essential to achieve optimal esthetic results with implant-borne restorations.

Device Description

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 45s 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 aftixes 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 mucoperiosted! flap over the esthetic healing cap after implant placement without subjecting the flap to tension.

AI/ML Overview

This is a pre-amendment 510k submission for a medical device from 1996. The provided text is a 510(k) Summary, which is a regulatory document to demonstrate substantial equivalence to legally marketed devices. It outlines the device's features and intended use but does not contain information about acceptance criteria, clinical studies, sample sizes, ground truth establishment, or expert involvement. These types of details are typical for modern AI/ML device submissions, which did not exist at the time this document was created.

Therefore, I cannot provide the requested information based on the provided text.

Summary

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K960634

ATTACHMENT 7 - 510(k) Summary

Applicant's Name and Address 1.

JUN 1 8 1996

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 Classitication Name: Accessory to a dental implant (21 CFR 872,3640)

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

ITI Large Closure Screw 1.
Branemark Healing Abutments 2.
1. Steri-Oss Healing Abutments
র্ব Implant Innovations' Healing Abutments

র্ব Description of the Device

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Intended Use of the Device ನ.

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

	Predicate Devices
Feature	ITI Large ClosureScrew	BrånemarkHealingAbutments	ImplantInnovationsHealingAbutments	Steri-OssHealingAbutments
Intended Use
To form,stabilize, andmaintain thesoft 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 directlyinto the implantduring softtissue healingperiod.	YES	YES	YES	YES

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
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.(b)
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.