(45 days)
Not Specified
No
The document describes a pre-mixed acrylic resin for dental prosthesis fabrication and repair. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies rely on similarity to predicate devices and biocompatibility, not algorithmic performance.
No.
The device is a pre-mixed acrylic resin intended for the laboratory fabrication of dental prosthesis and appliances, not a therapeutic device itself.
No
Explanation: The device is a pre-mixed acrylic resin used for the fabrication of dental prostheses and appliances, not for diagnosing medical conditions.
No
The device description clearly states it is a "pre-mixed acrylic resin," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for the "laboratory fabrication of dental prosthesis" and various dental appliances. This involves creating physical devices that are placed in the mouth, not performing tests on biological samples to diagnose a condition.
- Device Description: The device is described as a "pre-mixed acrylic resin" used for fabrication and repair. This is a material used to build something, not a reagent or instrument used for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information
- Using reagents or calibrators
The device is clearly intended for the creation of dental prosthetics and appliances, which falls under the category of medical devices used for treatment or support, not diagnosis.
N/A
Intended Use / 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.
Product codes
EBI, MOC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
SMH Flex "S" was also evaluated as follows: L929 Mem Elution Test - Non Cytotoxic Intracutaneous Injection Test -- Non Irritant Kligman Maximization Test - Non Sensitivity
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
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.(b)
Classification. Class II.
0
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
1
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.
2
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.
3
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
4
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