INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS

K031322 · Intra-Lock International · DZE · Dec 23, 2003 · Dental

Device Facts

• Record ID: K031322
• Device Name: INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS
• Applicant: Intra-Lock International
• Product Code: DZE · Dental
• Decision Date: Dec 23, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intra-Lock Hydroxyapatite Coated Implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or maxilla and to support removable or fixed prosthesis, from single tooth replacement to full arch reconstruction.

Device Story

Intra-Lock Hydroxyapatite Coated Implants are root-form dental implants manufactured from commercially pure titanium (CP Ti) with a hydroxyapatite coating. Available in threaded or smooth cylindrical designs, these implants are surgically placed into the mandible or maxilla by dental professionals to support fixed or removable dental prostheses. They serve as anchors for tooth replacement, ranging from single-tooth restorations to full-arch reconstructions. The device functions as a mechanical support structure for prosthetic dentistry, facilitating osseointegration through its hydroxyapatite-coated surface. Clinical benefit includes restoration of oral function and aesthetics for edentulous patients.

Clinical Evidence

Bench testing only. The submission relies on demonstrating conformity with the FDA's 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments' to establish safety and effectiveness.

Technological Characteristics

Root-form dental implants; material: CP Ti with hydroxyapatite coating; designs: threaded or smooth cylindrical; intended for endosseous placement in mandible or maxilla.

Indications for Use

Indicated for partially or fully edentulous patients requiring restoration in the mandible or maxilla; supports removable or fixed prosthesis ranging from single tooth replacement to full arch reconstruction.

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

• Ace HA Screw Implant System (K021244)
• HA-TI Implant (K003045)
• BMR Dental Implant System (K010343)
• Replace Ha Coated Implants (K962845)
• Sterngold HA Coated Screws (K981516)
• Restore HA Coated Implants (K960288)

Submission Summary (Full Text)

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K031322

# DEC 2 3 2003

## 510(k) Summary

Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Intra-Lock International is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." Intra-Lock International chooses to submit a summary of the safety and effectiveness information. The summary is as follows:

| Trade Name: | Intra-Lock Hydroxyapatite Coated Implants |
|----------------------|--------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Intra-Lock International<br>1200 North Federal Highway, Suite 200<br>Boca Raton, FL 33432<br>Registration No.:3003631996 |
| Device Generic Name: | HA Coated Dental Implants |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class III. |

#### Predicate Devices:

| Ace HA Screw Implant System | K021244 |
|-----------------------------|---------|
| HA-TI Implant | K003045 |
| BMR Dental Implant System | K010343 |
| Replace Ha Coated Implants | K962845 |
| Sterngold HA Coated Screws | K981516 |
| Restore HA Coated Implants | K960288 |

#### Product Description:

The Intra-Lock Hydroxyapatite Coated Implants consists of root form dental implants that are manufactured from CP Ti and have a Hydroxyapatite coating. These implant designs are either threaded or smooth cylindrical shapes and are substantially equivalent to devices previously marketed. They have the same indications and applications for surgical restoration of partially or fully edentulous patients as pre-amendment devices.

#### Indications for Use:

The Intra-Lock Hydroxyapatite Coated Implants have been designed to restore partially or fully edentulous The implants have been designed to be used in either the mandible or maxilla and to support patients. removable or fixed prosthesis, from single tooth replacement to full arch reconstruction.

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## Safety and Performance:

This submission is a Special 510(k): Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Previoret Notifications." In support of this 510(k), Intra-Lock International has provided information to demonstate conformity with FDA's guidance document entitled: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments Draft Guidance for Industry and FDA.

### Conclusion:

Based on the indications for use, technological characteristics, and comparison to predicate devices, the Intra-Lock Hydroxyapatite Coated Implants have been shown to be safe and effectiver for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 2003

Mr. Jeffrey Sakoff Vice Present & Director of Operations Intra-Lock International 1200 N. Federal Highway, Suit #200 Boca Raton, Florida 33432

Re: K031322

Trade/Device Name: Intra-Lock Hydroxyapatite Coated Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: September 29, 2003 Received: September 30, 2003

Dear Mr. Sakoff:

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 approval application (PMA). You may, therefore, market the device, subject to the general controls provisions 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 your device can 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 Federal Register.

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Page 2 - Mr. Sakoff

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact 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 Division 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,

Kein Muley

Se 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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Intra-Lock Hydroxyapatite Coated Dental Implants Device Name:

Indications for Use:

The Intra-Lock Hydroxyapatite Coated Implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or maxilla and to support removable or fixed prosthesis, from single tooth replacement to full arch reconstruction.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-the -Counter Use

M. Ulich for MSR

(Division Sigr (Division Sign-Oll)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K031522