TRYOUT-VPS HOLDING PASTE

K122974 · Crown Delta Corp. · EMA · May 17, 2013 · Dental

Device Facts

• Record ID: K122974
• Device Name: TRYOUT-VPS HOLDING PASTE
• Applicant: Crown Delta Corp.
• Product Code: EMA · Dental
• Decision Date: May 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2

Intended 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.

Device Story

TRYOUT is a translucent vinyl polysiloxane (VPS) holding paste used by dentists in clinical settings. It provides temporary stabilization for ceramic crowns and veneers on prepared teeth. The paste allows the clinician to evaluate fit, perform re-contouring or trimming, and conduct esthetic assessments before permanent fixation. The device acts as a temporary adhesive medium, enabling the dentist to verify the restoration's appearance and marginal integrity without permanent bonding. It benefits the patient by ensuring the final restoration is properly adjusted and esthetically acceptable before final cementation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Vinyl polysiloxane (VPS) based paste. Translucent formulation. Designed for temporary stabilization of dental restorations. Class II device under 21 CFR 872.3275 (Dental Cement).

Indications for Use

Indicated for temporary stabilization of ceramic crowns and veneers on prepared teeth to facilitate fit evaluation, re-contouring, trimming, and esthetic assessment by dentists prior to permanent cementation.

Regulatory Classification

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. 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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or waves.

#### 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Image /page/1/Picture/8 description: The image contains the words "Kwame Ulmer" in a bold, sans-serif font. The letters are arranged vertically, with "Kwame" on top and "Ulmer" below. To the right of the names is a geometric design that appears to be a stylized logo or symbol. The design incorporates lines and shapes, creating a visually interesting element alongside the text.

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: