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 Description

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 171 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 cavily.

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 171 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.

AI/ML Overview

The document provided is a 510(k) summary for a dental abutment, not a study reporting on the performance of an AI/ML powered device. As such, it does not contain the information required to answer your prompt regarding acceptance criteria and a study proving a device meets those criteria for an AI/ML system.

The document describes the ITI Angled Abutment and compares its features to other legally marketed predicate devices. It clearly outlines the intended use, design, and composition of the device. However, it does not mention any acceptance criteria in the context of device performance metrics or any study that would typically be conducted for an AI/ML powered medical device (e.g., a standalone performance study, MRMC study, or details about training and test sets).

Therefore, I cannot provide the requested table and information as it is not present in the provided text.

Summary

{0}------------------------------------------------

K962647
oct. 7, 1996

ATTACHMENT 9 - 510(k) Summary

Applicant's Name and Address 1.

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

Name of the Device 2.

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

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

ITI Angled Abutment (K941393) 1.
1. Branemark Angled Abutment (K905434)
1. Calcitek Angled Abutment (K number unknown)
1. 3i Angled Abutment (K number unknown)

4. Description of the Device

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 abulment 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

{1}------------------------------------------------

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 transter pin. The impression cylinder and transfer pin are reinserted into the impression material and the cast is poured, incorporating the transter 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. It 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

	Subject Device	Predicate Devices
	ITI ModifiedAngled Abutment	PreviouslyCleared ITIAngledAbutment	BrånemarkAngledAbutment	Calcitek AngledAbutment	3i AngledAbutment
Intended Use
Provide support fordental prosthesis	Yes	Yes	Yes	Yes	Yes
For use withcementedrestorations	Yes	Yes	Yes	Yes	Yes
For use withscrew-retainedrestorations	Yes	Yes	No	No	No
Design
Screwed into implantto be used as a basefor dental prosthesis	Yes	Yes	Yes	Yes	Yes
Available degreesof angulation	15 ° and 20°	15 ° and 20°	17° and 30°	15° and 25°	15°, 25°,and 35°
Composition
Composed ofTitanium	Yes	Yes	Yes	Yes	Yes
K Number			K905434	unknown	unknown

Summary of Device Compared to Predicate Devices ర్.

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.