(46 days)
Elite H-D putties are thick, vinyl polysiloxane dental impression materials intended to be used in conjunction with more fluid vinyl polysiloxane impression materials in order to make dental impressions. The resulting impressions are used to make plaster models of the teeth.
Elite H-D Vinyl Polysiloxane Impression Materials - Putty Soft/Normal Setting & Fast Setting
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a dental impression material, establishing its substantial equivalence to a predicate device. It defines the intended use of the device but does not detail performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment for a performance study.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Evan Dick, Ph.D. President Zhermack S.P.A. C/O E.G. Dick & Associates 7527 Westmoreland Avenue St. Louis, Missouri 63105
Re: K972239 Trade Name: Elite H-D Vinyl Polysiloxane Impression Materials - Putty Soft/Normal Setting & Fast Setting Regulatory Class: II Product Code: ELW Dated: June 16, 1997 Received: June 16, 1997
AUG - I 1997
Dear Dr. Dick:
【【相】【德德登】 张】【 】【
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 Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical
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General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 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 labelinq 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski 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: K972239
Device Name:
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Elite H-D Vinyl Polysiloxane Impression Materials
- · Putty Soft / Normal Setting
· Putty Soft / Fast Setting
Indications For Use:
Elite H-D putties are thick, vinyl polysiloxane dental impression materials intended to be used in conjunction with more fluid vinyl polysiloxane impression materials in order to make 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 Runner | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K972239 |
| Prescription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| (per 21 CFR 01.109) |
(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).