TEMPO CEM (MULTIPLE)

K970775 · Foremost Dental Mfg., Inc. · EMA · Jun 3, 1997 · Dental

Device Facts

• Record ID: K970775
• Device Name: TEMPO CEM (MULTIPLE)
• Applicant: Foremost Dental Mfg., Inc.
• Product Code: EMA · Dental
• Decision Date: Jun 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TempoCem is a dental luting agent for the temporary cementation of provisional crowns and bridges. Federal law restricts this device to sale by, or on the order of a dentist, or other practitioner licensed by the law of the state in which he or she practices to use or order the use of this device.

Device Story

TempoCem is a dental luting agent used by dentists for temporary cementation of provisional crowns and bridges. It functions as a bonding material to secure temporary restorations during the interim period before permanent cementation. The device is applied by the clinician in a dental office setting. It provides temporary retention, allowing for easy removal of the provisional restoration when necessary. Benefits include clinical convenience and protection of the prepared tooth structure during the provisional phase.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental luting agent; chemical composition typical of temporary dental cements. Formulated for temporary adhesion and manual removal. No electronic, software, or complex mechanical components.

Indications for Use

Indicated for temporary cementation of provisional crowns and bridges in dental patients. 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
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN - 3 1997

Mr. D. Tim Wolf
Regulatory Affairs Manager
Foremost Dental Mfg, Incorporated
242 - South Dean Street
Englewood, New Jersey 07631

Re: K970775
Trade Name: TempoCem (Multiple)
Regulatory Class: II
Product Code: EMA
Dated: April 25, 1997
Received: April 29, 1997

Dear Mr. Wolf:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your

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Page 2 - Mr. Wolf

premarket notification submission does not affect any obligation you
might have under sections 531 through 542 of
the Act for devices under the Electronic Product Radiation Control
provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as
described in your 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 and additionally 809.10 for in vitro
diagnostic devices), please contact the Office of Compliance at (301)
594-4692. Additionally, for questions on the promotion and
advertising of your device, please contact the Office of Compliance
at [phone]. Also, please note the regulation entitled,
"Misbranding by reference to premarket notification" (21 CFR 807.97).
Other general information on your responsibilities under the Act may
be obtained from the Division of Small Manufacturers Assistance at
its toll-free number [phone] or [phone] or at its
internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control,
and General Hospital Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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K970775/A1
Page ___ of ___

510(k) Number (if known): K970775

Device Name: TEMPOCEM (Multiple)

Indications For Use:

TempoCem is a dental luting agent for the temporary cementation of provisional crowns and bridges.

Federal law restricts this device to sale by, or on the order of a dentist, or other practitioner licensed by the law of the state in which he or she practices to use or order the use of this device.

(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 Dental, Infection Control,
and General Hospital Devices
510(k) Number K970775

Prescription Use: 2-4
(Per 21 CFR 801 709)

Over-the-Counter Use: No
(Optional Format 1-2-96)

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