(38 days)
Not Found
Not Found
No
The description focuses on the material properties and dispensing mechanism of a temporary dental resin, with no mention of AI or ML.
No.
The device is a material for fabricating temporary prostheses, not a device that directly treats or prevents disease or injury. Its function is to create a temporary dental restoration until a permanent one is available.
No
The device is a composite material used to fabricate temporary dental restorations, not to diagnose a medical condition or disease.
No
The device description clearly states it is a composite material supplied in cartridges, indicating a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for making temporary prostheses (crowns or bridges) for use in the mouth until permanent restorations are fabricated. This is a direct application to the patient's body.
- Device Description: The description details a composite material used for fabricating provisional restorations for teeth. This is a material applied to the teeth, which are part of the patient's body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not involve testing samples from the body.
Therefore, this device falls under the category of a dental material used for direct application to the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For making temporary prostheses, such as crowns or bridges, for use until permanent restorations can be fabricated.
Product codes (comma separated list FDA assigned to the subject device)
EBG
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
MAY 21 1999
45
510(k) SUMMARY
| Submitter: | Parkell Products Inc.
155 Schmitt Blvd.
Box 376
Farmingdale, NY 11735
FAX: 516-249-1242
TEL: 516-249-1134 | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact: | Nelson J. Gendusa, DDS
Director of Research
Parkell
155 Schmitt Blvd.
Box 376
Farmingdale, 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-KE
and 3M QUIKPLUS. | |
| Description/Intended Use: | Parkell's temporary C&B resin is a composite material intended for
use as in the fabrication of provisional restorations for teeth prepar-
ed 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 mini-
mal 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 | |
1
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.
2
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
3
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
Image /page/3/Picture/7 description: The image shows a solid black circle. The circle is slightly irregular in shape, with some minor imperfections along its perimeter. The background is white, providing a stark contrast to the black circle. The image is simple and minimalist, focusing solely on the shape and color of the circle.