(44 days)
Elite H-D impression products are vinyl polysiloxane dental impression materials intended to be used for making very accurate dental impressions. The resulting impressions are used to make plaster models of the teeth.
Elite H-D Hydrophilic Vinyl Polysiloxane Impression Materials - Light Body / Normal Setting - Light Body / Fast Setting - Regular Body - Heavy Body
I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding dental impression materials. It does not contain any information about acceptance criteria or a study that proves a device meets those criteria. Therefore, I cannot fulfill your request to describe acceptance criteria and a study based on this document.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 16 1997
Evan Dick, Ph.D. ·President C/O E.G. Dick & Associates Zhermack S.P.A. 7527 Westmoreland Avenue St. Louis, Missouri 63105
Re : K972027 Elite H-D Hydrophilic Vinyl Polysiloxane Trade Name: Impression Materials Requlatory Class: II Product Code: ELW May 28, 1997 Dated: Received: June 2, 1997
Dear Dr. Dick:
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 Requlations, Title 21, Parts 800 to 895. ਰੋ 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
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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 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 regulation (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
Time 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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K972027
Device Name:
Elite H-D Hydrophilic Vinyl Polysiloxane Impression Materials
- · Light Body / Normal Setting
- · Light Body / Fast Setting
- · Regular Body
- · Heavy Body
Indications For Use:
Elite H-D impression products are vinyl polysiloxane dental impression materials intended to be used for making very accurate dental impressions.
The resulting impressions are used to make plaster models of the teeth.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Kurr
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. K972027
Prescription Use_ 1 (per 21 CFR 01.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).