SR IVOCRON

K013869 · Ivoclar Vivadent, Inc. · EBG · Aug 28, 2002 · Dental

Device Facts

• Record ID: K013869
• Device Name: SR IVOCRON
• Applicant: Ivoclar Vivadent, Inc.
• Product Code: EBG · Dental
• Decision Date: Aug 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cold technique: With the Cold Liquid, SR Ivocron may be used for temporaries, securing ground denture teeth, and repair of PMMA. Hot technique: When used with the Hot Liguid, this technique may be used for temporaries and inexpensive crowns and bridges. For crowns and bridges, SR lvocron must be layered over a metal framework. Press (flasking) technique: For the press technique, SR Ivocron is mixed with the Press Liquid and may be used for temporaries and inexpensive crowns and bridges. For crowns and bridges, the material must be pressed over a metal framework.

Device Story

SR Ivocron is a dental resin material used for fabrication of temporary crowns, bridges, repair of PMMA, and securing denture teeth. Device utilized by dental professionals in clinical settings. Three application techniques: Cold (with Cold Liquid), Hot (with Hot Liquid), and Press/Flasking (with Press Liquid). For crowns and bridges, material requires application over a metal framework. Product serves as a restorative material for temporary dental applications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Temporary crown, bridge, and tooth shade resin material. Classified as Class II (Product Codes EBG and EBF). Utilizes specific liquid components (Cold, Hot, or Press) for polymerization/curing based on the chosen technique. Requires metal framework for crown and bridge applications.

Indications for Use

Indicated for dental patients requiring temporary crowns, bridges, repair of PMMA, or securing of ground denture teeth. Contraindicated for use without a metal framework when used for crowns and bridges.

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 8 2002

Ms. Donna M. Hartnett Assistant Corporate Counsel Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

Re: K013869

Trade/Device Name: SR Ivocron Regulation Number: 872.3770 and 872.3690 Regulation Name: Temporary Crown, Bridge Resin and Tooth Shade Resin Material Regulatory Class: II Product Code: EBG and EBF Dated: May 28, 2002 Received: May 30, 2002

Dear Ms. Hartnett:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controle Existing major regulations affecting vour 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.

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.

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Page 2 - Ms. Hartnett

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone] . 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski 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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510(k) Number (if known): K013869

Device Name:

SR Ivocron

Indications For Use:

Cold technique: With the Cold Liquid, SR Ivocron may be used for temporaries, securing ground denture teeth, and repair of PMMA.

Hot technique: When used with the Hot Liguid, this technique may be used for temporaries and inexpensive crowns and bridges. For crowns and bridges, SR lvocron must be layered over a metal framework.

Press (flasking) technique: For the press technique, SR Ivocron is mixed with the Press Liquid and may be used for temporaries and inexpensive crowns and bridges. For crowns and bridges, the material must be pressed over a metal framework.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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Division of Anesthesiology. General Hospital, Intection Control. Der

510(k) Number: