(57 days)
Premise Modified is a dental composite restorative material intended to be used in all classes of cavities.
The device is a light cured resin based composite dental restorative designed for direct placement. By utilizing three types of fillers, Premise Modified is designed to offer high polishability, high mechanical strength, and decreased polymerization shrinkage.
The provided text is a 510(k) summary for a dental composite restorative material called "Premise Modified." This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way an AI/ML device would. Instead, it focuses on demonstrating that the new device (Premise Modified) is substantially equivalent to an existing device (Premise) based on its intended use, design, and function.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study to prove device performance as it does not exist in the provided text for this type of medical device submission. The questions like "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance," "type of ground truth used," "sample size for the training set," and "how ground truth for the training set was established" are not applicable to this document because it is not describing an AI/ML device or a performance study with such metrics.
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Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a simple, sans-serif font. The logo is black and white.
APR - 3 2009
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: February 2009
Device Name:
- Trade Name - Premise Modified
- . Common Name - Dental Composite Restorative Material
- . Classification Name - Tooth Shade Resin Material, per 21 CFR § 872.3690
Devices for Which Substantial Equivalence is Claimed:
- . Kerr Dental Materials Center, Premise
Device Description:
The device is a light cured resin based composite dental restorative designed for direct placement. By utilizing three types of fillers, Premise Modified is designed to offer high polishability, high mechanical strength, and decreased polymerization shrinkage.
Intended Use of the Device:
The intended use of Premise Modified is for use in all classes of cavities.
Substantial Equivalence:
Premise Modified is substantially equivalent to other legally marketed devices in the United States. Premise Modified functions in a manner similar to and is intended for the same use as Premise that is currently marketed by Kerr Corporation.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Kerr Corporation C/o Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
APR - 3 2009
K090292 Re:
Trade/Device Name: Premise Modified Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: March 23, 2009 Received: March 25, 2009
Dear Ms. Garman:
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 - Ms. Garman
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runner
Ginette Y. Michaud, M.D. Acting 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
510(k) Number (if known):
Device Name: Premise Modified
Indications For Use:
Premise Modified is a dental composite restorative material intended to be used in all classes of cavities.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Purver
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K040921
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§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.