MONOPAQUE

K990315 · Ivoclar North America, Inc. · EBF · Mar 4, 1999 · Dental

Device Facts

• Record ID: K990315
• Device Name: MONOPAQUE
• Applicant: Ivoclar North America, Inc.
• Product Code: EBF · Dental
• Decision Date: Mar 4, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Intended Use

Monopaque is intended to be used for masking exposed metal in cases of defective ceramic and composite veneers.

Device Story

Monopaque is a dental material used by clinicians to mask exposed metal surfaces in defective ceramic or composite veneers. The device is applied directly to the metal surface to improve aesthetic outcomes. It functions as an opaque masking agent to hide underlying metal structures. Used in dental clinical settings by licensed professionals. Benefits include improved cosmetic appearance of dental restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental masking material for ceramic and composite veneers. Class II device (Product Code EBF).

Indications for Use

Indicated for masking exposed metal in patients with defective ceramic or composite veneers.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 4 1999

Mr. Peter P. Mancuso Ouality Assurance/Requlatory Affairs Manager Ivoclar North America, Incorporated 175 Pineview Drive Amherst, New York 14228

Re : K990315 Monopaque Trade Name: Regulatory Class: II Product Code: EBF Dated: January 25, 1999 February 1, 1999 Received:

Dear Mr. Mancuso:

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 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). 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 reqistration, 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Mancuso

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation (21 CFR Part 801 and additionally 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 807.97). Other qeneral 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/dsma/dsmamajn.html".

Sincerely yours,

Timothy A. Ulatowski

Direttor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): 14903) 5

Device Name:_ lono pague

Indications For Use:

Intended Use: Monopaque is intended to be used for masking exposed metal Incended ose. Monopuqal in increasin of defective ceramic and composite veneers.

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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)

Siman Runns

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number