Abutments are intended to be placed into dental implants as support for prosthetic reconstructions such as crowns and bridges. The abutments are indicated for cemented restoration in areas of the mouth and used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.

Device Description

The Titan Dental Implant Attachments and accessories are an integrated system of endosseous implant abutments, which are designed to support prosthetic devices for partially, or fully edentulous patients. The system consists of a variety of dental implant abutments and accessories. The devices covered in this submission include abutments, combination transfer coping/permanent abutments and miscellaneous accessories.

AI/ML Overview

I'm sorry, but based on the provided document, I cannot fulfill your request for information about acceptance criteria and a study proving device performance.

Here's why:

The document is a 510(k) clearance letter. This type of document from the FDA indicates that a device has been found substantially equivalent to a predicate device already on the market. It does not typically contain detailed information about performance studies, acceptance criteria, or specific clinical trial results.
The content focuses on regulatory classification and substantial equivalence. The provided text discusses the device name, classification, intended use, and the FDA's determination that it is substantially equivalent to existing devices. There's no mention of performance metrics, study designs, sample sizes, or ground truth establishment.
The device is an "Endosseous Dental Implant Abutment." For devices like this, the 510(k) clearance often relies heavily on material equivalence, design equivalence, and established safety and effectiveness of the predicate device, rather than new, extensive clinical performance studies with specific statistical acceptance criteria for "device performance" in the way one might see for an AI diagnostic tool, for example.

Therefore, the specific information requested in your numbered points (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) is not present in the provided 510(k) summary.

Summary

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SUMMARY OF K042715

ADMINISTRATIVE INFORMATION

Manufacturer Name:	Titan Implants, Inc.18 Columbia Ave.Bergenfield, NJ 07621Telephone (201) 439-0027Fax (201) 439-1145
Official Contact:	Cyril Chen
DEVICE NAME:
Classification Name:	Abutment, Implant, Dental, Endosseous (NHA)
Trade/Proprietary Name:	TITAN Dental Implant Attachment
Common Name:	Endosseous Dental Implant Abutment
Predicate Device:	TITAN Titanium Abutment Heads for IMZ implants K00381

DEVICE CLASSIFICATION

FDA has classified endosseous dental implants as Class II devices (21 CFR 872.3640 according to revision 69 FR 26307, May 12, 2004. Endosseous dental implant abutments are Class II devices (21 CFR 872.3630). The product code for "Abutment, Implant, Dental, Endosseous" is (NHA). Endosseous dental implants and abutments are reviewed by the Dental Products Panel.

DEVICE DESCRIPTION

INTENDED USE

The titanium abutment heads are intended for use with the various implants, and are designed for restorations where standard crown and bridge techniques are desired. The range of application is from full arch restoration to single tooth placement. These devices may also be used as a base for transitional appliances.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2005

Mr. Cyril Chen Technical Coordinator Titan Implants, Incorporated 18 Columbia Avenue Bergenfield, New Jersey 07621

Re: K042715

Trade/Device Name: TITAN DENTAL IMPLANT ATTACHMENTS Regulation Number: 872.3630 Regulation Name: Endosseous Implant Abutments Regulatory Class: II Product Code: NHA Dated: March 14, 2005 Received: March 15, 2005

Dear Mr. Chen:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becares in ed the device is substantially equivalent (for the referenced above and have and no the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce prior to that have been reclassified in accordance with the provisions of Annonents, or to do roos man metic Act (Act) that do not require approval of a premarket the Federal F 60a; Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the sixting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 wr (), it may of back of Federal Regulations, Title 21, Parts 800 to 898. In your device carroe foundish further announcements concerning your device in the Eederal Register.

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Page 2 - Mr. Chen

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DTS Issualites of that your device complies with other requirements mean that 177A has made a determinations administered by other Federal agencies. of the Act of ally rederal statutes and regarments, including, but not limited to: registration You must comply with an the Fice org (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), labeling systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocean mains of substantial equivalence of your device to a premarket nothleation. The PDA maing of sassification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at vice for your as at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general missimational and Consumer Assistance at its toll-free Division of 01638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sylerte Michie, md.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (K042715):

Device Name: TITAN DENTAL IMPLANT ATTACHMENTS

Indication for use:

Prescription Use : Yes________________________________________________________________________________________________________________________________________________________

( Part 21 CFR 801 Subpart D)

Over-The- Counter Use_________________________________________________________________________________________________________________________________________________________

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE –CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation ( ODE)

Susent Kumar

General Hospital

Number: K042715

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)