HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)

K123273 · Temrex Corp. · EMA · Dec 7, 2012 · Dental

Device Facts

• Record ID: K123273
• Device Name: HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)
• Applicant: Temrex Corp.
• Product Code: EMA · Dental
• Decision Date: Dec 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hoffmann's cements (Phosphate- Normal, quick setting) is indicated for the temporary application of provisional crowns, bridges, inlay, and onlays. Luting/ lining cements.

Device Story

Hoffmann's Cement is a phosphate-based dental cement used for temporary fixation of provisional dental restorations (crowns, bridges, inlays, onlays) and as a luting or lining material. It is intended for professional use by dentists in a clinical setting. The device functions as a chemical adhesive/luting agent to secure temporary prosthetics. It is applied manually by the clinician during dental procedures to provide temporary retention and protection of prepared tooth structures. The device benefits the patient by facilitating the temporary restoration process during the interval between tooth preparation and final prosthetic placement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Phosphate-based dental cement. Formulated as normal or quick-setting variants. Used for luting and lining applications. Class II medical device (21 CFR 872.3275).

Indications for Use

Indicated for temporary cementation of provisional crowns, bridges, inlays, and onlays, and as a luting/lining cement in dental patients.

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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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 7, 2012

Mr. Ethan Levander President Temrex Corporation 300 Buffalo Avenue FREEPORT NY 11520

Re: K123273

Trade/Device Name: Hoffmann's Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: October 19, 2012 Received: October 19, 2012

Dear Mr. Levander:

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. Levander

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of acrised that i Dr winds on that your device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must or any I call 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 Cl it i art 607); fusomig (21 CFR 803); good manufacturing practice requirements as set de rece teater adverse overies) { i 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 11 you dostre spec.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for go to map.rwww.radiological Health's (CDRH's) Office of Compliance. Also, please the eenter rolled, "Misbranding by reference to premarket notification" (21CFR Part note the regulation entined. This 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 Tou may bound one: gefant only gefantional 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 yours,

# Kwame, O., Ulmer

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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## Indications for Use

### 510(k) Number (if known): K123273

Device Name: Hoffmann's Cement

**Indications For Use:**

Indications For Use: Hoffmann's cements (Phosphate- Normal, quick setting) is indicated for the temporary application of provisional crowns, bridges, inlay, and onlays. Luting/ lining cements.

x Prescription Use (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)

2012.12.07 Susan Runner DDS, MA -13:00:26 -05'00'

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthealology, Gental Devices Division of Anesules.org.org.
Infection Control, Dental Devices

K125273

510(k) Number:

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