MASKY

K973542 · Pressing DI Monticelli Rag. Stefano · EBI · Feb 10, 1998 · Dental

Device Facts

• Record ID: K973542
• Device Name: MASKY
• Applicant: Pressing DI Monticelli Rag. Stefano
• Product Code: EBI · Dental
• Decision Date: Feb 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

To cover exposed portions of metallic frameworks in partial denture prostheses, for more natural appearance.

Device Story

Masky is a resin material used to cover exposed metallic frameworks in partial denture prostheses and orthodontic wires. The device is applied to the metal surface and cured via heat to create a biologically inert coating. By masking the metal, the device provides a more natural appearance for the patient. It is intended for use by dental professionals in a clinical or laboratory setting. The primary benefit is the reduction of the visual impact of metallic dental components.

Clinical Evidence

Bench testing only. Biocompatibility studies performed by Istituti Ortopedici Rizzoli in 1996 included: in vitro chromosomal aberration evaluation, cell viability testing using propidium iodide uptake, Ames Salmonella/microsome mutagenicity test, and sister chromatid exchange evaluation. Results indicated no negative findings contraindicating use in dental prostheses.

Technological Characteristics

Resin material for dental prosthetics; heat-cured; biologically inert post-curing; intended for application over metallic frameworks (CrCo).

Indications for Use

Indicated for patients requiring partial denture prosthetics with exposed metal framework or orthodontic appliances with visible wires to improve aesthetic appearance.

Regulatory Classification

Identification

A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.

Predicate Devices

• ArtGlass (K954115)

Submission Summary (Full Text)

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K973542

Pressing North America, Inc. 4311 SW Research Way Corvallis, Oregon 97333 541 754 1238 PHONE [phone] FAX

September 15, 1997

## 510(k) Summary

This is to notify you of the intention of Pressing North America, Inc. to import and distribute the following device for:

ressing Di Monticelli Italy Emilia Romagna 233 033 Cattolica, Italy 011 378909948 Phone [phone] Fax Stefano Monticelli, Administrator Establishment #9026751

Contact person for Pressing North America, Inc. (submitter): Thomas D. Maddux, 4311 SW Research Way, Corvallis, Oregon, 97333. Phone [phone], Fax [phone]

Proprietary Name: MASK Y

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Common or Usual Name:. Tooth shade resin material

Establishment Registration Number: 3031160

Classification name: 872.690

Performance Standard: Unknown

Substantial Equivalence: This product is similar in design, composition, and function to ArtGlass, manufactured by Hereaus Kulzer which was the subject of Premarket Notification #K954115.

510(k) summary

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Intended Use: To cover exposed portions of metallic frameworks in partial denture prostheses, for more natural appearance.

Technological Characteristics: Resin material that is biologically inert once cured on the metallic framework, similar to ArtGlass, with exception of curing methodology. ArtGlass cures by light; Masky by heat.

Clinical Performance Summary: Both ArtGlass and Masky are biologically inert once cured; tests as performed by the Istituti Ortopedici Rizzoli for Pressing Italy on the material address standard tests for biocompatibility. The tests, performed in December 1996, are enclosed in this 510(k) application; as follows:

- 1. EVALUATION OF CHROMOSOMAL ABERRATIONS INDUCED IN VITRO BY HEAT CURING RESIN FOR THE COVERING OF CrCo PROSTHESES;
- 2. EVALUATION OF THE EFFECT OF HEAT CURING RESIN FOR THE COVERING OF CrCo PROSTHESES ON CELL VIABILITY USING PROPIDIUM IODIDE UPTAKE;
- 3. MUTAGENICITY OF HEAT CURING RESIN FOR THE COVERING OF CrCo PROSTHESES IN THE AMES SALMONELLA / MICROSOME TEST;
- 4. EVALUATION OF SISTER CHROMATID EXCHANGE IN VITRO INDUCED BY HEAT CURING RESIN FOR THE COVERING OF CACo PROSTHESES.

Clinical Performance Conclusions: Masky had no negative results in testing that contraindicates use with dental prostheses.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 1998

Mr. Thomas D. Maddux Corporate Secretary Pressing DI Monticelli Rag. Stefano C/O Pressing North America Incorporated 4311 SW Research Way Corvallis, Oregon 97333

Re : K973542 Trade Name: Masky Requlatory Class: II EBI Product Code: Dated: January 28, 1998 Received: January 30, 1998

Dear Mr. Maddux:

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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895 ... A .. . . . substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 regulation 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. Maddux

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" (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

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

Enclosure

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| Page | |
|------|---|
| 01 | 1 |

| 510(k) Number (if known): | K973542 |
|---------------------------|---------|
| Device Name: | Masky |

Indications For Use:

## Statement of Indications for Use:

Masky is indicated for use when patients require a partial denture prosthetic that has a substantial amount of exposed metal in the frame. Masky covers exposed metal areas to reduce visual impact of framework in the mouth. Can also cover wires used in orthodontic appliances to make appliances less visible.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Suank Rurrer

(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control, and General Hospital Devices 10 510(k) Number

Prescription Use ી (Per 21 CFR 801.109)

OR

Over-The-Counter Use No

(Optional Format 1-2-96)