(76 days)
Not Found
Not Found
No
The summary describes a dental cement and does not mention any AI or ML components or functionalities.
No
Explanation: This device is a cement used for temporary dental restorations. It does not exert any therapeutic effect on the body; its function is purely mechanical or structural.
No
Explanation: The "Intended Use / Indications for Use" states that the device is a "temporary resin-based cement designed to be used in conjunction with temporary restorations." This describes a therapeutic or restorative function, not a diagnostic one. Diagnostic devices are used to identify or detect medical conditions.
No
The device description clearly states it is a "dual cured, self-cured and visible light-cured, resin-based cement," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a temporary cement for dental restorations (crowns, bridges, etc.). This is a dental device used directly on the patient's teeth.
- Device Description: The description reinforces its use as a cement for temporary dental work.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) to provide diagnostic information. IVDs are used in vitro (outside the body) to diagnose conditions, monitor treatments, or screen for diseases.
Therefore, TempBond Clear - 2 falls under the category of a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of TempBond Clear - 2 is for temporary cementation of temporary restorations such as crowns, bridges, inlays and onlays.
TempBond Clear - 2 is a dual-cured, temporary resin-based cement designed to be used in conjunction with temporary restorations such as crowns, bridges, inlays and onlays.
Product codes
EMA
Device Description
The device is a dual cured, self-cured and visible light-cured, resin-based cement designed to be used in conjunction with temporary crowns, bridges, inlays and onlays. The highly translucent nature of TempBond Clear - 2 provides a pleasing, tooth-like appearance even when margins are exposed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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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)
TempBond Clear
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for Sybron Dental Specialties, Inc. The word "SYBRON" is in large, bold, sans-serif font at the top. Below that, "DENTAL SPECIALTIES, INC." is written in a smaller, sans-serif font. The logo is black and white.
Image /page/0/Picture/2 description: The image shows a handwritten string of characters and numbers. The string appears to be "K982390". The characters are written in a cursive style, with some connections between the letters and numbers. The writing is dark and clear against a white background.
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: July 1998
Device Name:
- Trade Name TempBond Clear 2 .
- . Common Name - Temporary Dental Cement
- Classification Name Dental Cement other than zinc oxide-eugenol, per 21 CFR & . 872.3275
Devices for Which Substantial Equivalence is Claimed:
- Kerr Corporation, TempBond Clear .
Device Description:
The device is a dual cured, self-cured and visible light-cured, resin-based cement designed to be used in conjunction with temporary crowns, bridges, inlays and onlays. The highly translucent nature of TempBond Clear - 2 provides a pleasing, tooth-like appearance even when margins are exposed.
Intended Use of the Device:
The intended use of TempBond Clear - 2 is for temporary cementation of temporary restorations such as crowns, bridges, inlays and onlays.
Substantial Equivalence:
TempBond Clear - 2 is substantially equivalent to several other legally marketed devices in the United States. The temporary dental cement marketed by Kerr Corporation functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Dental Materials Center.
Image /page/0/Picture/20 description: The image shows a recycling symbol next to the words "Printed on Recycled Paper". The recycling symbol is a triangle made of arrows, indicating the material can be recycled. The text indicates that the paper used for printing is made from recycled materials, promoting environmental consciousness.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular fashion around a stylized emblem. The emblem depicts a stylized caduceus, a symbol often associated with medicine and healthcare, with a distinctive design of intertwined snakes and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 8 1998
Ms. Colleen Boswell Senior Regulatory Affairs Specialist Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Oranqe, California 92867
Re : K982590 Trade Name: TempBond Clear - 2 Regulatory Class: II Product Code: EMA Dated: July 24, 1998 Received: July 24, 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 reqistration, 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 connect 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
Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section 1 - Indications for Use
510(k) Number:
TempBond Clear - 2 Device Name:
Indications for Use:
TempBond Clear - 2 is a dual-cured, temporary resin-based cement designed to be used in conjunction with temporary restorations such as crowns, bridges, inlays and onlays.
(Division Sign-Off)
(Division Sign-Off)
[Prescription Device
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K982590