MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM

K070601 · Intra-Lock International · DZE · Oct 12, 2007 · Dental

Device Facts

• Record ID: K070601
• Device Name: MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM
• Applicant: Intra-Lock International
• Product Code: DZE · Dental
• Decision Date: Oct 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Mini Drive-Lock™ Dental Implants are intended for use as a self-tapping titanium screw for transitional or intra-bony long-term applications. Mini Drive-Lock™ Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants should be used and may be restored after a period of time or placed in immediate function.

Device Story

Mini Drive-Lock™ Dental Implant System consists of machined, self-tapping titanium alloy screw-form implants. Used for transitional or long-term maxillary and mandibular tissue-supported denture stabilization. Implants placed by dental professionals in clinical settings. System provides mechanical support for dentures; allows for immediate function or delayed restoration. Benefits include stabilization of dentures for patients requiring long-term or transitional support.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Titanium-6Al-4V ELI alloy (ASTM F 136). Form factor: Screw-form dental implants, 2.0mm and 2.5mm diameters, lengths 10mm-18mm. Energy source: None (mechanical). Connectivity: None. Sterilization: Sterile packaged.

Indications for Use

Indicated for long-term maxillary and mandibular tissue-supported denture stabilization in patients requiring transitional or intra-bony long-term applications. Multiple implants used; may be restored after a period or placed in immediate function.

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

• Dentatus Monorail™ (K040143)
• ERA™ Implant (K021045)
• Imtec Sendax™ MDI and MDI Plus (K031106)

Submission Summary (Full Text)

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# 510(k) Summary

OCT 1 2 2007

| Establishment: | Intra-Lock International, Inc.<br>1200 North Federal Highway<br>Suite 209<br>Boca Raton, FL 33432 |
|----------------------|---------------------------------------------------------------------------------------------------|
| Proprietary Name: | Mini Drive-Lock™ Dental Implant System |
| Classification Name: | Endosseous Dental Implant (21 CFR 872.3640) |

Device Classification: Class II

Product Name

Company

510(k)

## Predicate Devices:

| Product Name | Company | 510(k) |
|-----------------------------------|-------------------|---------|
| Dentatus Monorail™ | NATS Corporation | K040143 |
| ERA™ Implant | Sterngold | K021045 |
| Imtec Sendax™ MDI and MDI<br>Plus | Imtec Corporation | K031106 |

- Device Description: The Intra-Lock Mini Drive-Lock™ Dental Implant System consists of machined Titanium, screw-form dental implants, 2.0mm and 2.5mm in diameter and available in lengths of 10mm, 11.5mm, 13mm, 15mm and 18mm. The implant raw material consists of Titanium Alloy for Surgical Implant Applications (as per ASTM F 136 Standard Specification for Wrought Titanium-6Aluminium-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401). The implants are sterile packaged.

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Mini Drive-Lock" Dental Implants are intended for use as a self-tapping Intended Use: titanium screw for transitional or intra-bony long-term applications.

> Mini Drive-Lock™ Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants should be used and may be restored after a period of time or placed in immediate function.

This submission is a Traditional 510(k) as described in Safety and Performance: FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Intra-Lock International has provided information to demonstrate conformity with FDA's guidance document entitled Endosseous Implants 872-3640.

Based on the indications for use, technological Conclusion: characteristics, and comparison to predicate devices, the Intra-Lock Mini Drive-Lock™ Implant System has been shown to be safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized human figure embracing a sphere, symbolizing the department's mission to protect and promote the health and well-being of Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 2 2007

Mr. Jeffery Sakoff Director of Operations Intra-Lock International, Incorporated 1200 North Federal Highway, Suite 209 Boca Raton, Florida 33432

Re: K070601

Trade/Device Name: Mini Drive-Lock™ Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 16, 2007 Received: August 16, 2007

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/industry/support/index.html.

Sincerely yours.

Syville y. Michie Davis.

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 (if known): K070601

Device Name: Mini Drive-Lock™ Dental Implant System

Indications for Use:

- Mini Drive-Lock™ Dental Implants are intended for use as a self-tapping titanium screw 3. for transitional or intra-bony long-term applications.
- Mini Drive-Lock™ Dental Implants are indicated for long-term maxillary and mandibular ধ ..
বাংলাদেশে পার্টির পাতালে বাংলাদেশ করে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে পারে করে পারে করে পারে করে পারে করে পারে করে পারে করে পারে করে পা tissue-supported denture stabilization. Multiple implants should be used and may be restored after a period of time or placed in immediate function.

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

Over the Counter Use (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)

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Sween Burns.

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

510(k) Number: KOTOGO)