(145 days)
Not Found
No
The summary describes a resin material for covering metal in dental prosthetics and orthodontic appliances. There is no mention of AI, ML, image processing, or any data-driven algorithms. The performance studies focus on biocompatibility testing of the material.
No.
The device's intended use is to cover exposed metal on partial dentures and orthodontic appliances to reduce their visual impact, which is an aesthetic purpose, not a therapeutic one.
No
The device is intended to cover exposed metal on partial dentures and orthodontic appliances for aesthetic purposes, rather than to diagnose any medical condition.
No
The device description clearly states it is a "Resin material" that is cured by heat, indicating it is a physical material, not software. The performance studies also focus on the biocompatibility of this material.
Based on the provided information, this device, Masky, is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of Masky is to cover exposed metal on partial dentures and orthodontic appliances for aesthetic purposes (reducing visual impact). This is a physical modification of a medical device for cosmetic reasons, not a diagnostic test performed on a biological sample.
- Device Description: Masky is a resin material used to cover metal. This is a material used in the fabrication or modification of a prosthetic device.
- Performance Studies: The performance studies described focus on the biocompatibility and safety of the material when used in the mouth, not on its ability to diagnose a condition or provide information about a patient's health status. The tests are related to the material's interaction with biological systems, which is relevant for a medical device, but not specifically for an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Masky does not fit this definition.
N/A
Intended Use / 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.
Product codes
EBI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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:
-
- EVALUATION OF CHROMOSOMAL ABERRATIONS INDUCED IN VITRO BY HEAT CURING RESIN FOR THE COVERING OF CrCo PROSTHESES;
-
- EVALUATION OF THE EFFECT OF HEAT CURING RESIN FOR THE COVERING OF CrCo PROSTHESES ON CELL VIABILITY USING PROPIDIUM IODIDE UPTAKE;
-
- MUTAGENICITY OF HEAT CURING RESIN FOR THE COVERING OF CrCo PROSTHESES IN THE AMES SALMONELLA / MICROSOME TEST;
-
- 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.
- EVALUATION OF SISTER CHROMATID EXCHANGE IN VITRO INDUCED BY HEAT CURING RESIN FOR THE COVERING OF CACo PROSTHESES.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
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.(b)
Classification. Class II.
0
Pressing North America, Inc. 4311 SW Research Way Corvallis, Oregon 97333 541 754 1238 PHONE 541 754 7478 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 011 378909958 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 541 754 1238, Fax 541 754 7478
Proprietary Name: MASK Y
<> <>
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
1
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:
-
- EVALUATION OF CHROMOSOMAL ABERRATIONS INDUCED IN VITRO BY HEAT CURING RESIN FOR THE COVERING OF CrCo PROSTHESES;
-
- EVALUATION OF THE EFFECT OF HEAT CURING RESIN FOR THE COVERING OF CrCo PROSTHESES ON CELL VIABILITY USING PROPIDIUM IODIDE UPTAKE;
-
- MUTAGENICITY OF HEAT CURING RESIN FOR THE COVERING OF CrCo PROSTHESES IN THE AMES SALMONELLA / MICROSOME TEST;
-
- 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.
2
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
3
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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
4
| 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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)