IMTEC SENDAX MDI ORTHO6 AND ORTHO8

K023067 · Imtec Corp. · DZE · Dec 3, 2002 · Dental

Device Facts

• Record ID: K023067
• Device Name: IMTEC SENDAX MDI ORTHO6 AND ORTHO8
• Applicant: Imtec Corp.
• Product Code: DZE · Dental
• Decision Date: Dec 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is a self-tapping titanium threaded screw indicated for long-term intra-bony applications, or as an inter-radicular transitional application. This device will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial endentulism, and employment of minimally invasive surgical interventions. Representative applications include the following: - Temporary (transitional supports for fixed or removable implant-supported prosthesis while O conventional implants are integrating.) - Stabilizing interim prostheses in graft sites and guided tissue regeneration applications to O avoid iatrogenic damage to healing grafts, membranes or integrating implants. - Introductory system for nervous or apprehensive potential patients, offering a simple O methodology for testing the actual "feel" of bone anchored implants, without a major commitment to final restorations. - As an interim system for medically compromised, handicapped or terminally ill patients to O enhance their comfort by maintaining a reasonable level of speech, mastication and general well being, at modest cost levels.

Device Story

IMTEC Sendax MDI ORTHO is a self-tapping titanium threaded screw designed for dental applications. It functions as an endosseous implant to provide immediate splinting stability and long-term fixation for crown and bridge prostheses. Used by dental professionals in clinical settings, the device supports minimally invasive surgical interventions. It serves as a transitional support during conventional implant integration, a stabilizer for interim prostheses in graft sites, a trial system for apprehensive patients, and a comfort-enhancing solution for medically compromised or terminally ill patients. The device is placed directly into the bone to anchor dental restorations, improving patient mastication, speech, and overall well-being.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Self-tapping titanium threaded screw; endosseous implant design; intended for intra-bony application.

Indications for Use

Indicated for patients requiring long-term intra-bony fixation or inter-radicular transitional support for crown and bridge installations, including full or partial edentulism. Applicable for temporary support during conventional implant integration, stabilization of interim prostheses in graft sites, patient acclimation to bone-anchored implants, and comfort maintenance for medically compromised or terminally ill patients.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized symbol consisting of three curved shapes that resemble a person embracing another person.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 3 2002

Mr. Brad Vance Director, Regulatory Affairs & New Projects IMTEC Corporation 2401 North Commerce · Ardmore, Oklahoma 73401

Re: K023067

Trade/Device Name: IMTEC Sendax MDI ORTHO Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: August 28, 2002 Received: September 16, 2002

Dear Mr. Vance:

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. Vance

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,

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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## INDICATIONS FOR USE STATEMENT

Device Name:

IMTEC Sendax MDI ORTHO

#### Indications for Use:

This device is a self-tapping titanium threaded screw indicated for long-term intra-bony applications, or as an inter-radicular transitional application.

This device will permit immediate splinting stability and long-term fixation of new or existing crown and bridge installations, for full or partial endentulism, and employment of minimally invasive surgical interventions.

Representative applications include the following:

- Temporary (transitional supports for fixed or removable implant-supported prosthesis while O conventional implants are integrating.)
- Stabilizing interim prostheses in graft sites and guided tissue regeneration applications to O avoid iatrogenic damage to healing grafts, membranes or integrating implants.
- Introductory system for nervous or apprehensive potential patients, offering a simple O methodology for testing the actual "feel" of bone anchored implants, without a major commitment to final restorations.
- As an interim system for medically compromised, handicapped or terminally ill patients to O enhance their comfort by maintaining a reasonable level of speech, mastication and general well being, at modest cost levels.

# PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED

## CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Prescription Use (Per 21 CFR 801.109)

or

Over the Counter Use

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

510(k) Number.

KGa3067