(77 days)
Vivadent, Fermit-N, Cosmedent, Inc., E-Z TEMP
Not Found
No
The 510(k) summary describes a temporary dental filling material and does not mention any AI or ML components or functionalities.
No
The device is a temporary filling material for dental use, not a therapeutic device. It is used for mechanical repair (filling), not to treat a disease, injury, or condition in a therapeutic manner.
No
The device is a temporary filling material, not a diagnostic tool. Its purpose is to fill preparations, not to identify or diagnose conditions.
No
The device description clearly states it is a "visible light-cured, single component temporary filling material," which is 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 describes the material being used directly in the mouth for temporary dental fillings, inlays, onlays, and implant screw-access openings. This is a direct application to the patient's body.
- Device Description: The description reinforces that it's a "temporary filling material" used for "temporary inlays and onlays."
- 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. The description of TempFil F - 2 does not involve any such testing or analysis of biological samples.
Therefore, TempFil F - 2 is a dental material used for direct application in the mouth, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of TempFil F - 2 is for temporary filling of inlay and onlay preparations, implant screw access openings and for the emergency replacement of lost fillings.
TempFil F - 2 is a light oured, single component temporary filling material intended l emplil F - Z is a light-successingle compensions in the go
to be used for inlay and only preparations, implantserew-access openings andto be assurement of lost fillings for the emergency
Product codes
EBU
Device Description
The device is a visible light-cured, single component temponery filling material. It is specifically designed for temporary inlays and onlays. TempFil F - 2 has a permanent elastic phase which allows for easy removal even in the presence of preparation undercuts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Vivadent, Fermit-N, Cosmedent, Inc., E-Z TEMP
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the date "SEP 30 1998" at the top. Below the date is the word "SYBRON" in large, bold letters. Underneath "SYBRON" is the text "DENTAL SPECIALTIES, INC." in smaller, bold letters. The image appears to be a logo or header for a dental company.
5982459
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Fassimile Colleen Boswell - Contact Person
Date Summary Prepared: July 1998
Device Name:
- Trade Name TempFil F 2 .
- Common Name Temporary Dental Restorative Material ●
Seetion III - 510(k) Summary of Safety and Effectiveness
- Classification Name Temporary Crown and Bridge Resin, per 21 CFR § 872.3770 .
Devices for Which Substantial Equivalence is Claimed:
- Vivadent, Fermit-N .
- Cosmedent, Inc., E-Z TEMP .
Device Description:
The device is a visible light-cured, single component temponery filling material. It is specifically designed for temporary inlays and onlays. TempFil F - 2 has a permanent elastic phase which allows for easy removal even in the presence of preparation undercuts.
Intended Use of the Device:
The intended use of TempFil F - 2 is for temporary filling of inlay and onlay preparations, implant screw access openings and for the emergency replacement of lost fillings.
Substantial Equivalence:
TempFil F - 2 is substantially equivalent to several other legally marketed devices in the United States. The temporary dental restoratives marketed by Vivadent and Cosmedent. Inc. function in a manner similar to and are intended for the same use as the product manufactured by Kerr Dental Materials Center.
Image /page/0/Picture/19 description: The image shows a recycling symbol next to the words "Printed on Recycled Paper." The recycling symbol is a triangle made of three arrows pointing in a clockwise direction. The text is in a simple, sans-serif font and is right-aligned to the recycling symbol. The image is likely used to indicate that the paper on which it is printed is made from recycled materials.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird-like figure, composed of three overlapping profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 1998
Ms. Colleen Boswell Senior Requlatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92867
Re : K982459 Trade Name: TempFil F - 2 Requlatory Class: II Product Code: EBU Dated: July 13, 1998 Received: July 15, 1998
Dear Ms. Boswell:
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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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. 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 regulations.
2
Page 2 - Ms. Boswell
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 fo
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 vours.
Susan Hugo
Timothy Alan Wharton
Timothy A. Ulatowski Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section I - Indications for Use
510(k) Number:
TempFil F - 2 Device Name:
Indications for Use:
TempFil F - 2 is a light oured, single component temporary filling material intended l emplil F - Z is a light-successingle compensions in the go
to be used for inlay and only preparations, implantserew-access openings andto be assurement of lost fillings for the emergency
Sissy Ruape
(Division Sign ( rif ) (Continent of Donus), Infection Control, and General Hospital Devi 510(k) Number ﺳﻌ Katzy