DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT

K120283 · Novocol, Inc. · EMA · Jul 31, 2012 · Dental

Device Facts

• Record ID: K120283
• Device Name: DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT
• Applicant: Novocol, Inc.
• Product Code: EMA · Dental
• Decision Date: Jul 31, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3275
• Device Class: Class 2

Intended Use

Dimer Dual Cure Temporary Resin Cement is indicated for the temporary cementation of provisional restorations such as crowns and Bridges, inlays and onlays, Maryland bridges, veneers or for the temporary cementation of permanent dental restorations. Dimer Dual Cure Permanent Resin Cement is indicated for the final cementation of implant prostheses, crowns and bridges, inlays and onlays, Maryland bridges, veneers, pins and posts and also periodontal splinting.

Device Story

Dimer Dual Cure Resin Cements (Temporary and Permanent) are dental materials used by dentists for the cementation of various dental restorations. The devices function as adhesive agents to secure crowns, bridges, inlays, onlays, veneers, implant prostheses, pins, and posts to tooth structure or implants. The dual-cure mechanism allows for both light-curing and self-curing, providing flexibility in clinical application. These cements are applied by the clinician during restorative dental procedures to ensure the stability and retention of the prosthetic device. The benefit to the patient is the secure attachment of dental restorations, facilitating proper function and aesthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dual-cure resin cement system. Materials include resin-based components. Formulated for both light-cure and self-cure polymerization. Intended for dental restorative applications.

Indications for Use

Indicated for temporary cementation of provisional restorations (crowns, bridges, inlays, onlays, Maryland bridges, veneers) or temporary cementation of permanent restorations; and final cementation of implant prostheses, crowns, bridges, inlays, onlays, Maryland bridges, veneers, pins, posts, and periodontal splinting. Prescription use only.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

Ms. Cora Breacho-Trosonis Director of Scientific and Regulatory Affairs Novocol, Incorporated 416 South Taylor Avenue Louisville, Colorado 80027

JUL 3 1 2012

Re: K120283

Trade/Device Name: Dimmer Dual Cure Permanent Resin Cement, Dimer Dual Cure Temporary Resin Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: July 11, 2012 Received: July 12, 2012

Dear Ms. Breacho-Trosonis:

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- Ms. Breacho-Trosonis

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. 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: "Dimer Dual Cure Temporary Resin Cement"

Indications for Use:

"Dimer Dual Cure Temporary Resin Cement" is indicated for the temporary cementation of provisional restorations such as crowns and Bridges, inlays and onlays, Maryland bridges, veneers or for the temporary cementation of permanent dental restorations.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology. General Hospital
Division of Anesthesiology. Dental Devices Division of Antonicental Devices

510(k) Number:

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## INDICATIONS FOR USE

510(k) Number (if known):

Device Name: "Dimer Dual Cure Permanent Resin Cement"

Indications for Use:

. : " . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

"Dimer Dual Cure Permanent Resin Cement" is indicated for the final cementation of implant prostheses, crowns and bridges, inlays and onlays, Maryland bridges, veneers, pins and posts and also periodontal splinting.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

ﺴﺴ

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Wh for

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K120283