TITAN DENTAL IMPLANT SYSTEM

K042971 · Titan Implants, Inc. · DZE · Jan 14, 2005 · Dental

Device Facts

• Record ID: K042971
• Device Name: TITAN DENTAL IMPLANT SYSTEM
• Applicant: Titan Implants, Inc.
• Product Code: DZE · Dental
• Decision Date: Jan 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TITAN Dental Implant System is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch and to provide support for crowns, bridges or overdentures.

Device Story

TITAN Dental Implant System consists of root-form solid screw-type implants and various abutments; used for dental restoration. Implants feature cylindrical, tapered, or stepped designs with external thread forms (V, square, buttress). Anti-rotational features include internal/external elements. Implants/abutments are surgically placed in maxillary or mandibular bone by dental professionals to support crowns, bridges, or overdentures. System includes healing abutments, temporary abutments, and laboratory components. Device provides structural foundation for prosthetic teeth, restoring oral function and aesthetics for patients.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Materials: CP titanium (ASTM F67, ISO 5832-2), Ti-6Al-4V ELI (ASTM F136, ISO 5832-3), Ti-13Nb-13Zr (ASTM F1713), gold alloy. Surface treatments: as-machined, grit blasted/acid etched, resorbable blast media (RBM), plasma-sprayed titanium (TPS), hydroxyapatite (HA) coating, titanium nitride. Dimensions: 3.25-6.5 mm diameter, 5.0-20.0 mm length. Mechanical design: root-form solid screw-type, cylindrical/tapered/stepped shapes. Non-software device.

Indications for Use

Indicated for patients requiring dental restoration via support for crowns, bridges, or overdentures through surgical placement in the maxillary or mandibular arch bone.

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

• Implant Innovations Osseotite Implants (K031632)
• Implant Innovations TG Osseotite Implants (K033430)
• Bicon Dental Implant II (K972029)
• Bicon Dental Implant II 4.5 mm (K994037)
• Bicon Dental Implant II 6.0 x 5.7 mm (K010185)
• BioHorizons Maestro Dental Implant (K972313)
• BioHorizons Maestro Dental Implant (K010458)
• Frialit-2 Dental Implant (K994376)
• Friadent XiVE Dental Implant (K021318)
• INNOVA Endopore Dental Implant (K032140)
• INNOVA Endopore Dental Implant (K040714)
• Lifecore Dental Implant (K002037)
• SteriOss (now Nobel Biocare) Replace Tapered Implant (K964220)
• SteriOss (now Nobel Biocare) Replace Cylindrical Implant (K980439)
• Straumann ITI Dental Implant System (K030007)
• Astra Tech Dental Implant System (K931767)

Submission Summary (Full Text)

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# TITAN Dental Implant System

04297/
Page

JAN | 4 2005

## ADMINISTRATIVE INFORMATION

.

| Manufacturer Name: | Titan Implants, Inc.<br>18 Columbia Ave.<br>Bergenfield , NJ 07621<br>Telephone [phone]<br>Fax [phone] |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Cyril Chen |
| Representative/Consultant: | Floyd G. Larson<br>PaxMed International<br>4329 Graydon Road<br>San Diego, CA 92130<br>Telephone [phone]<br>FAX [phone] |
| DEVICE NAME | |
| Classification Name: | Implant, Dental, Endosseous (DZE)<br>Abutment, Implant, Dental, Endosseous (NHA) |
| Trade/Proprietary Name: | TITAN Dental Implant System |
| Common Name: | Endosseous Dental Implant<br>Endosseous Dental Implant Abutment |

# ESTABLISHMENT REGISTRATION NUMBER

The Establishment Registration number for Titan Implants, Inc. is 2249649. The Owner/Operator number is 9041410.

## 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). The product code for "Implant, Dental, Endosseous" is DZE. 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.

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#### INTENDED USE

The TITAN Dental Implant System is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch and to provide support for crowns, bridges or overdentures.

#### DEVICE DESCRIPTION

#### Design Characteristics

The TITAN Dental Implant System is comprised of 26 root-form solid screw-type implant designs and a broad range of abutment designs, all of which are based on existing dental implant systems that are cleared for marketing in the United States. Implant design features include external shapes that are cylindrical (15 designs), tapered (10 designs) and stepped (1 design). Both transgingival and submerged designs are included. External implant thread forms include V, square and buttress designs. Anti-rotational features include external and internal design elements. All implants are made from titanium or titanium alloys conforming to ASTM and ISO standards. Surfaces include as-machined surfaces, grit blasted and acid etched surfaces, surfaces treated with resorbable blast media (RBM) and surfaces coated with plasma-sprayed titanium (TPS) or hydroxyapatite (HA). Diameters range from 3.25 mm to 6.5 mm, and lengths from 5.0 mm to 20.0 mm..

Abutment designs include long and short conical abutments, stepped abutments, gold cylinder abutments, gold/plastic castable abutments and ball head abutments. Antirotational features include external and internal design elements. All abutments are made from titanium or titanium alloys conforming to ASTM and ISO standards or from gold alloy. Surfaces include as-machined surfaces and surfaces treated with titanium nittide. Platform diameters range from 3.25 mm to 6.5 mm.

Abutment screws appropriate to each implant/abutment combination, healing abutments, temporary abutments and laboratory components are included in the TITAN Dental Implant System.

#### Material Composition

The implants, abutments and accessories for the TITAN Dental Implant System are made from CP titanium Grades 2 & 4 conforming to ASTM F67 and ISO 5832-2, Ti-6Al-4V ELI alloy conforming to ASTM F136 and ISO 5832-3 or Ti-13Nb-13Zr alloy conforming to ASTM F1713. The surface of the threaded portion of the TITAN dental implants is one of the following: as-machined, grit blasted and acid etched, treated with resorbable blast media (RBM), coated with plasma-sprayed titanium or coated with plasma-sprayed hydroxyapatite (HA). Collar portions are smooth machined. The abutment surfaces are as-machined or coated with titanium nitride. In addition, one design of abutment screw is surface treated using the Tiodize process.

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# TITAN Dental Implant System

# EQUIVALENCE TO MARKETED PRODUCT

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For the purposes of FDA's regulation of medical devices, the TITAN Dental Implant System is substantially equivalent in indications and design principles to the following predicate devices:

- Implant Innovations Osseotite Implants cleared on September 16, 2003 under K031632 .
- Implant Innovations TG Osseotite Implants cleared November 7, 2003 under K033430 .
- Bicon Dental Implant II cleared August 18, 1997 under K972029 .
- Bicon Dental Implant II 4.5 mm cleared January 11, 2000 under K994037 .
- Bicon Dental Implant II 6.0 x 5.7 mm cleared December 30, 2002 under K010185 .
- BioHorizons Maestro Dental Implant cleared September 16, 1997 under K972313 .
- BioHorizons Maestro Dental Implant cleared May 16, 2001 under K010458 .
- Frialit-2 Dental Implant cleared March 24, 2000 under K994376 ●
- Friadent XiVE Dental Implant cleared July 2, 2002 under K021318 .
- INNOVA Endopore Dental Implant cleared October 2, 2003 under K032140 .
- INNOVA Endopore Dental Implant April 9, 2004 under K040714 .
- Lifecore Dental Implant cleared May 16, 2001 under K002037 .
- SteriOss (now Nobel Biocare) Replace Tapered Implant cleared March 5, 1997 . under K964220
- SteriOss (now Nobel Biocare) Replace Cylindrical Implant cleared March 16, . 1998 under K980439
- Straumann ITI Dental Implant System cleared March 31, 2003 under K030007 .
- Astra Tech Dental Implant System cleared February 8, 1994 under K931767. .

The TITAN Dental Implant System has the following similarities to the predicate devices:

- · has the same intended use,
- · uses the same operating principle,
- · incorporates the same basic design,
- · incorporates the same materials, and
- · is packaged and sterilized using the same or equivalent materials and processes.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three branches instead of the usual one.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2005

Titan Implants, Incorporated C/O Mr. Floyd G. Larson PaxMed International 4329 Graydon Road San Diego, California 92130

Re: K042971

Trade/Device Name: TITAN Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: October 25, 2004 Received: October 28, 2004

Dear Mr. Larson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket the Fouchar F 600; Drag). You may, therefore, market the device, subject to the general approvial upprivious of the Act. The general controls provisions of the Act include requirements for annual registration, listing 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 (1111), it ancan be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

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Page 2 - Mr. Larson

Please be advised that FDA's issuance of a substantial equivalence determination does not I Tease be advisod that I Dr. determination that your device complies with other requirements mount that 127 may made statutes and regulations administered by other Federal agencies.

You must comply with all the Act's requirements, including, but not limited to: registration 1 od listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 ce read in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quarty ijon control provisions (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 anon you to began finding of substantial equivalence of your device to a premaired predicate device results in a classification 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), 11 you deente the Office of Compliance at [phone]. 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 overn of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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: K042971

Device Name: TITAN Dental Implant System

Indications for Use:

The TITAN Dental Implant System is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch and to provide support for crowns, bridges or overdentures.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Re Muly for MSP

(Division Sign-Off) Division of Anesthesiology, Generai Hospital Infection Control, Dental Device

510(k) Number: K042971

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