SMH FLEX S

K073040 · Smh Biomaterial AG · EBI · Dec 13, 2007 · Dental

Device Facts

• Record ID: K073040
• Device Name: SMH FLEX S
• Applicant: Smh Biomaterial AG
• Product Code: EBI · Dental
• Decision Date: Dec 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

SMH Flex "S" is intended for the laboratory fabrication of dental prosthesis including the repair and relining of complete and/or partial dentures, occlusal splints, night guards. tooth positioners, snoring and sleep apnea devices, and other appliances as prescribed

Device Story

SMH Flex "S" is a pre-mixed acrylic resin used by dental laboratory technicians for the fabrication, repair, and relining of dental prostheses and appliances. The material is processed in a laboratory setting to create custom dental devices such as occlusal splints, night guards, and sleep apnea appliances. It functions as a structural material for dental restorations. The device is intended for professional use as prescribed by a dentist.

Clinical Evidence

No clinical data. Evidence consists of bench testing including L929 Mem Elution (non-cytotoxic), intracutaneous injection (non-irritant), and Kligman Maximization (non-sensitivity) tests.

Technological Characteristics

Pre-mixed acrylic resin. Characteristics include mechanical properties, water absorption, solubility, residual monomer concentration, biocompatibility, opaque factor, and density/consistency.

Indications for Use

Indicated for laboratory fabrication, repair, and relining of dental prostheses, including complete/partial dentures, occlusal splints, night guards, tooth positioners, and snoring/sleep apnea devices. Prescription use only.

Regulatory Classification

Identification

A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.

Predicate Devices

• Talon & Revere (K071245)
• Ivocap Elastomer (K896130)

Submission Summary (Full Text)

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# k073040

# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

#### Submitter Information: SMH BioMaterial AG

DEC 1 3 2007

Date Summary Prepared: 10th October 2007

## Contact Persons: Ashley Truitt

#### Device Name:

Trade Name(s): SMH Flex "S" Classification Name: Denture resin, relining, repairing or rebasing resin Panel: Dental Product Code: EBI

#### Predicate Device Information:

| Device Name | Manufacturer | 510(k) Reference |
|------------------|-----------------------|------------------|
| Talon & Revere | Comfort Acrylics | K071245 |
| Ivocap Elastomer | Ivoclar Vivodent GmbH | K896130 |

## Device Description:

The submitted device SMH Flex "S" is a pre-mixed acrylic resin for use in the laboratory fabrication of dental prosthesis such as the repair and relining of complete and/or partial dentures, dental appliances including, occlusal splints, night guards, tooth positioners, snoring and sleep apnea devices.

# Intended Use:

SMH Flex "S" is intended for the laboratory fabrication of dental prosthesis including the repair and relining of complete and/or partial dentures, occlusal splints, night guards. tooth positioners, snoring and sleep apnea devices, and other appliances as prescribed

Technological Characteristics Compared with Predicate Device Mechanics, Water Absorption & Solubility, Rest Monomer Concentration, Biocompatibility, Opaque Factor and Density & Consistency.

SMH Flex "S" was also evaluated as follows: L929 Mem Elution Test - Non Cytotoxic Intracutaneous Injection Test -- Non Irritant Kligman Maximization Test - Non Sensitivity

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# Performance Test Data and Conclusions:

We conclude that the similarity in composition between SMH Flex "S" and the predicate we concided that the performance data and biocompatibility results, supports the safety and effectiveness of SMH Flex "S" for the indicated uses.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)" around the perimeter. Inside the circle is a stylized image of three human figures facing to the right, represented by curved lines.

DEC 1 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SMH BioMaterial AG C/O Ms. Ashley Truitt Consultant Sonomed, Incorporated 3537 Teasley Lanc Denton, Texas 76210

Re: K073040

Trade/Device Name: SMH Flex "S" Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Codes: EBI and MOC Dated: October 10, 2007 Received: October 29, 2007

Dear Ms. Truitt:

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 vour 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- Ms. Truitt

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 vours.

Sylette Y. Michauds

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 K073040 510(k) Number (if known):

Device Name: SMH Flex "S"

Indications for Use:

SMH Flex "S" is intended for the laboratory fabrication of dental prosthesis including the repair and relining of complete and/or partial dentures, occlusal splints, night guards, tooth positioners, snoring and sleep apnea devices, and other appliances as prescribed.

Prescription Use XX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Swam

K073040