(233 days)
Crown Delta's TRYOUT – Translucent Shade VPS Holding Paste is to be used for the temporary stabilization of ceramic crowns and veneers on prepared teeth while the dentist evaluates fit, re-contours and/or trims, and performs an esthetic assessment prior to permanent fixation with cement.
TRYOUT - Translucent Shade VPS Holding Paste
I am sorry, but the provided text from the FDA 510(k) K122974 letter for "TRYOUT - Translucent Shade VPS Holding Paste" does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications that you have requested.
This document is a letter from the FDA to Crown Delta Corporation stating that their device, TRYOUT - Translucent Shade VPS Holding Paste, is substantially equivalent to a legally marketed predicate device. It confirms the regulatory classification and general controls applicable to the device.
The "Indications for Use" section (page 3) describes the intended use of the product, but it does not include any performance metrics or study results.
Therefore, I cannot provide the requested information based on the text provided.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 17, 2013
Mr. Mark Konopka Crown Delta Corporation 1550 Front Street YORKTOWN HEIGHTS NY 10598
Re: K122974
Trade/Device Name: TRYOUT - Translucent Shade VPS Holding Paste Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: March 29, 2013 Received: April 9, 2013
Dear Mr. Konopka:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Mr. Konopka
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
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for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and
Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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Crown Delta Corporation 510(k) Submission TRYOUT - Translucent Shade VPS Holding Paste
Section D - Page 1 of 1 (Rev. 3)
Indications for Use
510 (k) Number (if known): K122974
Device Name: TRYOUT – Translucent Shade VPS Holding Paste
Indications for Use:
Crown Delta's TRYOUT – Translucent Shade VPS Holding Paste is to be used for the temporary stabilization of ceramic crowns and veneers on prepared teeth while the dentist evaluates fit, re-contours and/or trims, and performs an esthetic assessment prior to permanent fixation with cement.
Prescription Use __ X
(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 AS NEEDED)
- Susan Runner, DDS, MA
Digitally signed by Mary S. Runner -S
DN: c=US, o=U.S. Government, ou=HHS
ou=FDA, ou=People, cn=Mary S. Runner
0.9.2342.19200300.100.1.1=1300087956
00 Date: 2013.05.10 10:57:20 -04'00'
esthestology, General Hospital on Control. Dental I
510(k) Number:
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.