IMCOR 4.00 & 5.00MM SELF-TAPPING LOCKTITE IMPLANTS, IMCOR 4.00 & 5.00MM SELF-TAPPING HA COASTED LOCKTITE IMPLANTS, AND I

K983563 · Imcor · DZE · Jan 11, 1999 · Dental

Device Facts

• Record ID: K983563
• Device Name: IMCOR 4.00 & 5.00MM SELF-TAPPING LOCKTITE IMPLANTS, IMCOR 4.00 & 5.00MM SELF-TAPPING HA COASTED LOCKTITE IMPLANTS, AND I
• Applicant: Imcor
• Product Code: DZE · Dental
• Decision Date: Jan 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

IMCOR implants are indicated to replace missing tooth roots for single tooth, partial tooth and fully edentulous patients. The IMCOR Implant System is designed to become an osseointegrated prostheses allowing the attachment of partial or complete prosthodontic appliances. The use of the IMCOR implant is the same as currently accepted uses for dental implants already in the marketplace. All components are to be used as labeled. Components are not intended to be bent by the clinician.

Device Story

IMCOR LockTite Implants are dental implants designed to replace missing tooth roots. Available in 4.00mm and 5.00mm diameters, they feature self-tapping designs with either HA (hydroxyapatite) coating or RBM (Resorbable Blast Media) surface treatments. Used by dental clinicians to achieve osseointegration, these implants serve as anchors for partial or complete prosthodontic appliances. The device is implanted surgically into the jawbone. By providing a stable foundation for prosthetic teeth, the system restores oral function and aesthetics for patients with tooth loss. No electronic or software components are involved.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use comparison to existing dental implants.

Technological Characteristics

Self-tapping dental implants; 4.00mm and 5.00mm diameters; surface finishes include HA coating and RBM (Resorbable Blast Media). Mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients with missing tooth roots, including single tooth, partial tooth, and fully edentulous cases, to support partial or complete prosthodontic appliances via osseointegration.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 1 1999

Robert S. Ura, D.D.S. IMCOR™ 74 Northeastern Boulevard, Building 19 Nashua, New Hampshire 03062

Re: K983563

> IMCOR™ 4.00 and 5.00mm Self-Tapping Trade Name: LockTite Implants, IMCOR™ 4.00 and 5.00mm Self-Tapping HA Coated LockTite Implants, and IMCOR™ 4.00 and 5.00mm Self-Tapping RBM Surface LockTite Implants Requlatory Class: III Product Code: DZE Dated: October 9, 1998 Received: October 13, 1998

Dear Dr. Ura:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Dr. Ura

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510/k) Number .<br>1000 9<br>KIIOWIII. | | |
|----------------------------------------|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | LAND STATE COLLECTION COLLECTION OF CLEAR | .<br>ANNE BELL FOR CO<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

IMCOR Implant Device Name:

## Indications For Use:

IMCOR implants are indicated to replace missing tooth roots for single tooth, partial tooth and fully edentulous patients.

The IMCOR Implant System is designed to become an osseointegrated prostheses allowing the attachment of partial or complete prosthodontic appliances. The use of the IMCOR implant is the same as currently accepted uses for dental implants already in the marketplace.

All components are to be used as labeled. Components are not intended to be bent by the clinician.

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runny

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number

Prescription Use _

OR

Over-The-Counter Use

(Per 21 CFR 801-109)

(Optional Format 1-2-96)