(78 days)
StandOut 2 is an impression material system intended for use on all crown and bridge, edentulous, orthodontic and implant impressions.
StandOut 2 is a dental impression material system that is suitable for all crown and bridge, edentulous, orthodontic and impressions StandOut2 is a two-part, base/catalyst -paste/paste system. The product is available in two viscosities, Wash and Tray.
This 510(k) summary for K072622 describes a dental impression material (StandOut 2) and asserts its substantial equivalence to a predicate device (StandOut). The provided document does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria.
Instead, it focuses on the administrative process of 510(k) clearance, device description, intended use, and substantial equivalence to a legally marketed predicate device.
Therefore, I cannot provide a response with the requested information as it is not present in the provided text. The document does not describe performance testing against specific acceptance criteria.
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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 printed in a smaller, sans-serif font. The logo is black and white.
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7488 - Facsimile Wendy Garman - Centact Person
Date Summary Prepared: September 2007
Device Name:
- . Trade Name - StandOut 2
- . Common Name - Impression Material
- Classification Name Impression Material, per 21 CFR § 872.3660 .
Devices for Which Substantial Equivalence is Claimed:
- . Sybron Dental Specialties, Inc., StandOut
Device Description:
Stand()ut 2 is a dental impression material system that is suitable for all crown and bridge, edentulous, orthodontic and impressions StandOut2 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 StandOut 2 is as a dental impression material system suitable for all crown and bridge, edentulous, orthodontic and implant impressions.
Substantial Equivalence:
Stand()ut 2 is substantially equivalent to other legally marketed devices in the United States. StandOut 2 functions in a manner similar to and is intended for the same use as the product Stand()ut cleared for marketing for Sybron Dental Specialties, Inc.
DEC 0 4 2007
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle symbol.
DEC () 4 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kerr Corporation C/O Ms. Wendy Garman Manager, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K072622
Trade/Device Name: StandOut 2 Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: September 14, 2007 Received: September 17, 2007
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 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 yours,
Suan
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
510(k) Number (if known):
K 072622
Device Name: StandOut 2
Indications For Use:
StandOut 2 is an impression material system intended for use on all crown and bridge, edentulous, orthodontic and implant impressions.
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)
| -- | -------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology General Hospital, | |
| Infection Control, Dental Devices |
| 510(k) Number: | K072622 |
|---|---|
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§ 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).