(38 days)
For making temporary prostheses, such as crowns or bridges, for use until permanent restorations can be fabricated.
Parkell's temporary C&B resin is a composite material intended for use as in the fabrication of provisional restorations for teeth prepared to receive crowns or bridges until final restorations for these teeth are completed. It is supplied in 50ml AutoMix Cartridges that automatically mix and dispense the proper ratio of base and catalyst (i.e., 1:1). The material is self-curing and sets with minimal heat and shrinkage. SmarTemp features a "rubbery" stage that permits easy trimming with scissors prior to final polymerization. SmarTemp has good physical properties and is suitable for long-term and long-span temporary restorations
The provided text is a 510(k) Summary for a dental product called "SmarTemp Temporary C&B Resin". It describes the product, its intended use, and its substantial equivalence to other legally marketed predicate devices.
However, the summary does not contain any information about specific acceptance criteria, study designs, sample sizes, or performance data for the "SmarTemp" device. The document is typical of a 510(k) summary from 1999, which primarily focuses on demonstrating substantial equivalence through a comparison of technological characteristics and intended use, rather than presenting detailed performance study results against predefined acceptance criteria.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth, as this information is not present in the provided text. The document only states that the device has "good physical properties" but does not quantify them or provide data from a study.
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MAY 21 1999
45
510(k) SUMMARY
| Submitter: | Parkell Products Inc.155 Schmitt Blvd.Box 376Farmingdale, NY 11735FAX: 516-249-1242TEL: 516-249-1134 | |
|---|---|---|
| Contact: | Nelson J. Gendusa, DDSDirector of ResearchParkell155 Schmitt Blvd.Box 376Farmingdale, NY 11735 | |
| Submission Date: | 09 April 1999 | |
| Trade Name: | SmarTemp | |
| Common Name: | TEMPORARY C&B RESIN | |
| Classification Name: | TEMPORARY CROWN & BRIDGE RESIN (CFR §872.3770) | |
| Equivalence: | LUXATEMP, PROVIPONT, PROTEMP GARANT, PROV-KEand 3M QUIKPLUS. | |
| Description/Intended Use: | Parkell's temporary C&B resin is a composite material intended foruse as in the fabrication of provisional restorations for teeth prepar-ed to receive crowns or bridges until final restorations for theseteeth are completed. It is supplied in 50ml AutoMix Cartridgesthat automatically mix and dispense the proper ratio of base andcatalyst (i.e., 1:1). The material is self-curing and sets with mini-mal heat and shrinkage. SmarTemp features a "rubbery" stage thatpermits easy trimming with scissors prior to final polymerization.SmarTemp has good physical properties and is suitable for long-term and long-span temporary restorations |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 1 1999
Nelson J. Gendusa, DDS Director of Research Parkell Products, Incorporated 155 Schmitt Boulevard Box 376 Farmingdale, New York 11735
Re : K991270 Trade Name: SmarTemp Requlatory Class: II EBG Product Code: Dated: April 9, 1999 Received: April 13, 1999
Dear Dr. Gendusa:
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. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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.
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Page 2 - Dr. Gendusa
this response to your premarket notification Please note: 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 regulations.
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) 594-4692. 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,
Patricia Cusack Hfor
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Image /page/3/Picture/0 description: The image shows a sequence of characters and numbers in a bold, handwritten style. The sequence starts with the letter 'K', followed by the numbers '991270'. Below the sequence, there is the text 'Page 1 of 1', indicating that this is the first and only page of a document.
| 510(k Number (if known): | K991270 |
|---|---|
| -------------------------- | --------- |
Device Name: _SMARTEMP TEMPORARY C&B RESIN
| Indications for Use: | For making temporary prostheses, such as crowns or bridges, for use until permanent restorations can be |
|---|---|
| fabricated. |
のお気になる。
の 2007年の1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には1000年に1000
Susan Punne
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K991070
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§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.