TRANSITIONAL IMPLANTS

K021915 · Intra-Lock International · DZE · Dec 19, 2002 · Dental

Device Facts

• Record ID: K021915
• Device Name: TRANSITIONAL IMPLANTS
• Applicant: Intra-Lock International
• Product Code: DZE · Dental
• Decision Date: Dec 19, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is designed to provide immediate transitional splinting stability or fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients. It is indicated for a maximum of one year.

Device Story

Intra-Lock Transitional Implant System consists of root form dental implants and restorative components; used for cement-retained or removable overdenture restorations. Implants measure 1.8mm width by 8, 10, or 15mm length. System includes placement instrument; provided sterile. Used by dental professionals in clinical settings to provide temporary stabilization or fixation of dental prosthetics. Benefits include immediate transitional support for patients during healing or prior to permanent restoration. Device is intended for short-term use (max one year).

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Root form dental implants; 1.8mm diameter; 8, 10, 15mm lengths. Sterile packaging. Includes placement instrument. Class III device per 21 CFR 872.3640.

Indications for Use

Indicated for partially or fully edentulous patients requiring immediate transitional splinting stability or fixation of new or existing crown, bridge, and denture installations for a maximum duration of one year.

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

• Sendax Mini Dental Implant (K972351)
• Dentatus Transitional Implants MTI-MP (K980620)
• Imtec Sendax MDI (K990983)

Submission Summary (Full Text)

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K02 1915

## 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 System |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Intra-Lock International<br>1200 North Federal Highway<br>Suite 200<br>Boca Raton, FL 33432<br>Registration No.: Active; Awaiting assignment of registration number. |
| Device Generic Name: | Transitional Implants |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class III. |

Predicate Devices:

| Sendax Mini Dental Implant | K972351 |
|---------------------------------------|---------|
| Dentatus Transitional Implants MTI-MP | K980620 |
| Imtec Sendax MDI | K990983 |

#### Product Description:

The Intra-Lock International Transitional Implant System consists of root form Transitional Implants and restorative components which can be used for cement retained or and removable overdenture type restorative options. The implants are 1.8mm in width by 10, 15 and 8mm in length. The implants are sterile packaged and include a placement instrument.

#### Indications for Use:

This device is designed to provide immediate transitional splinting stability or fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients. It is indicated for a maximum of one year.

#### Safety and Performance:

This submission is a Special 510(k): Abbreviated 510(k) as described in FDA's guidance document entitled "The New SIO(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.

#### Conclusion:

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

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features an abstract image of an eagle with three lines representing its head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Public Health Service

DEC 1 9 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jeffery Sakoff Director of Operations Intra-Lock International, Incorporated 1200 North Federal Highway, Suite 200 Boca Raton, Florida 33432

Re: K021915

Trade/Device Name: Transitional Implants Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: October 3, 2002 Received: October 18, 2002

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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Patrice Cucumiffer

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page

510(k) Number (if known):

Device Name: Intra-Lock Transitional Implant System

Indications for Use:

This device is designed to provide immediate transitional splinting stability or fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients. It is indicated for a maximum of one year.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-the -Counter Use

Susan Runon

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

510(k) Number: K021915