MODIFICATION TO IMTEC SENDAX MDI

K990983 · Imtec Corp. · DZE · Apr 13, 1999 · Dental

Device Facts

• Record ID: K990983
• Device Name: MODIFICATION TO IMTEC SENDAX MDI
• Applicant: Imtec Corp.
• Product Code: DZE · Dental
• Decision Date: Apr 13, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

To provide immediate transitional splinting stability or ongoing fixation of new/ existing crown, bridge and denture instillations in partial or fully endentulous settings.

Device Story

IMTEC Sendax MDI is a self-tapping titanium screw (1.8 mm width; 13, 15, 18 mm lengths) used as a dental anchor post. Operated by dental professionals in clinical settings, the device is surgically placed into bone to provide immediate transitional stability or fixation for dental prostheses. It serves as a temporary support during conventional implant integration, a stabilizer for interim prostheses in graft sites, or a low-commitment introductory system for patients. By providing stable anchorage, the device enables improved mastication, speech, and patient comfort. The device is intended for prescription use.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Self-tapping titanium screw; 1.8 mm diameter; 13, 15, and 18 mm lengths. Mechanical fixation device. Biocompatible titanium construction. Sterilization method not specified.

Indications for Use

Indicated for partial or fully edentulous patients requiring intra-bony and inter-radicular transitional support for crown, bridge, and denture fixation. Used for temporary support during conventional implant integration, stabilization of interim prostheses in graft sites, and as an introductory system for apprehensive patients or medically compromised/terminally ill patients to improve mastication and speech. Contraindicated in patients with local infection, vascular impairment, uncontrolled diabetes, chronic high-dose steroid use, clotting disorders, anticoagulant therapy, metabolic bone disease, or other systemic disorders affecting bone/wound healing.

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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4/13/99

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#### 510 (k) Summary :IMTEC Sendax MDI

#### SUBMITTED BY:

M. K. Patterson, Jr. PhD Sr Vice President Regulatory Affairs IMTEC Corporation 2401 North Commerce Ardmore. Oklahoma 73401 [phone]

F.D.A Registration Number: 1645158 Owner / Operator Number: 9003407

Date Submitted: March 22,1999

## CLASSIFICATION/COMMON OR USUAL NAME/ DEVICE NAME:

Classification Name: Splint, Endonic Stabilizing (CFR 872.3890) Common/ Usual Name: Dental Anchor Post Proprietary Name: IMTEC Sendax MDI™M

## DEVICE DESCRIPTION:

Self-tapping titanium screw, 1.8 mm in width by 13, 15and 18 mm lengths.

## INDICATIONS FOR USE:

To provide immediate transitional splinting stability or ongoing fixation of new/ existing crown, bridge and denture instillations in partial or fully endentulous settings.

#### CONTRAINDICATIONS:

Contraindications customary to the placement of dental implants should be observed. These include, but are not limited to, current local infection, vascular impairment, uncontrolled diabetes, chronic high doses of steroids, clotting disorders, current anticoagulant therapy, metabolic bone disease, and other metabolic or systemic disorders which will affect bone or wound healing. Excessive loading or placement of implants in inadequate bone may result in fracture.

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summary con't.

# COMPLICATIONS:

Possible complications with any oral reconstructive surgery include infection, closure perforation, abscess formation, bone loss, pain, soft tissue irregularities, and additional complications associated with anesthesia and dental surgery.

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

Comparable biocompatabile titanium material, manufactur, sterilization methods, and intended application

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads, representing health, human services, and prevention. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 3 1999

M.K Patterson, Jr., Ph.D. Senior Vice President, Requlatory Affairs IMTEC Corporation 2401 North Commerce Ardmore, Oklahoma 73401

Re: K990983 Modification to IMTEC Sendax MDI Trade Name: Regulatory Class: III Product Code: DZE March 22, 1999 Dated: Received: March 24, 1999

Dear Dr. Patterson:

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 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 The general controls provisions of the Act 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 (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. ಗಿ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Dr. Patterson

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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.fdp.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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990983 510(k) Number -972351

Device Name:IMTEC Sendax MDI

Indications For Use:

This device is a self- tapping titanium threaded screw indicated for intra-bony and inter-radicular transitional application, to permit immediate splinting stability and ongoing fixation of new or existing crown and bridge instillations, for full or partial edentulism, an employing minimally invasive surgical intervention.

Representative applications include the following:

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div align="center"><i>Susen</i></div> |
|---------------|----------------------------------------|
| | (Division Sign-Off) |
| | Division of Dental, Infection Control, |
| | and General Hospital Devices |
| 510(k) Number | 19990983 |

Prescription Use✓

Over-The-Counter Use (Optional Format 1-2-96)