(52 days)
Stand Out is an addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous and implant impression techniques.
The device is an addition-cure vinyl polysiloxane dental impression material that is used for all crowns and bridges, edentulous and implant impression techniques. Stand Out is a two-part, base/catalyst - paste/paste system. The product is available in two viscosities, Wash and Tray.
The provided text is a 510(k) Summary of Safety and Effectiveness for a dental impression material named "Stand Out." It contains information about the device's name, common name, classification, predicate devices, device description, and intended use. However, it does not include any information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical studies (such as MRMC or standalone studies).
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document focuses on regulatory submission for substantial equivalence rather than reporting detailed study results or performance metrics.
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Image /page/0/Picture/0 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized, interconnected design, with a curved line above the letters. Below the design, the words 'SYBRON DENTAL SPECIALTIES' are written in a simple, sans-serif font.
JUL 0 3 2003
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: May 2003
Device Name:
- Trade Name Stand Out ●
- Common Name -- Dental Impression Material .
- Classification Name Impression Material, per 21 CFR & 872.3660 .
Devices for Which Substantial Equivalence is Claimed:
- Dentsply Caulk, Aquasil UltraMonophase/Heavy/LV Smart Wetting Impression . Material
Device Description:
The device is an addition-cure vinyl polysiloxane dental impression material that is used for all crowns and bridges, edentulous and implant impression techniques. Stand Out is a two-part, base/catalyst - paste/paste system. The product is available in two viscosities, Wash and Tray.
Intended Use of the Device:
The intended use of Stand Out is for all crowns and bridges, edentulous and implant impressions.
Substantial Equivalence:
Stand Out is substantially equivalent to other legally marketed devices in the United States. Stand Out functions in a manner similar to and is intended for the same use as Aquasil UltraMonophase/Heavy/LV Smart Wetting Impression Material that is currently manufactured by Dentsply Caulk.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties. Incorporated 1717 W. Collins Avenue Orange, California 92867
JUL 03 2003
Re: K031484
Trade/Device Name: Stand Out Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Codes: ELW Dated: May 08, 2003 Received: May 12, 2003
Dear Ms. Boswell:
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. Colleen Boswell
Please be advised that FDA s issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.html
Sincerely yours.
Kein Mchuy
Sa Susan Runner, DDS, MA Interim 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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Section I - Indications for Use
Ver/ 3 - 4/24/96
Applicant: Kerr Corporation
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K031484 |
| Device Name: | Stand Out |
Indications For Use:
Stand Out is an addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous and implant impression techniques.
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| Labels | Values |
|---|---|
| 510(k) Number. | K031484 |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).