(43 days)
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No
The document describes a dental cement and does not mention any AI or ML components or functionalities.
No.
The device is a temporary dental cement used for restorations, not a device that treats, prevents, or diagnoses a disease or condition. The inclusion of triclosan, an antibacterial agent, does not automatically classify it as therapeutic; its primary function remains to temporarily hold dental restorations in place.
No
Explanation: The device is a temporary dental cement used for securing restorations. It does not perform any diagnostic function; rather, it is a therapeutic/restorative material.
No
The device description clearly indicates it is a physical cement product packaged in a syringe, not a software application.
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 direct application within the body (or on a structure that will be placed in the body), not for testing samples taken from the body.
- Device Description: The description details a dental cement, its properties, and how it's packaged and used in a dental context.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the body (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The intended use of TempBond Clear with Triclosan is for the temporary cementation of temporary restorations such as crowns, bridges, inlays, onlays and splints.
TempBond Clear with Triclosan is a dual-cured, temporary, eugenol-free, transparent, resin-based cernent with triclosan designed to be used in conjunction with temporary restorations such as crowns, bridges, inlays, onlays and splints.
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
TempBond Clear with Triclosan is a dual-cured, temporary, eugenol-free, resin-based cement with triclosan. This base/catalyst cement is flexible and transparent when cured. The device will be packaged in a dual-barrel syringe to eliminate hand mixing. It has excellent flow to permit the restoration to be easily and completely seated. It is strong enough to withstand the stresses of mastication, yet permits easy removal of the restoration when it is desired. TempBond Clear with Triclosan contains triclosan.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.
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Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters "SDS" in a stylized font, with a swooping line above the letters. Below the letters, the words "SYBRON DENTAL SPECIALTIES" are printed in a simple, sans-serif font. The logo is black and white.
FEB 3 2006
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 100 Bayview Circle, Suite 6000 Newport Beach, California 92660 (949) 255-8766 - Phone (949) 255-8763 - Facsimile Colleen Boswell - Contact Person
December 2005 Date Summary Prepared:
Device Name:
- Trade Name -- TempBond Clear with Triclosan .
- Common Name Temporary Dental Cement .
- Classification Name Dental Cement other than zinc oxide-eugenol, per 21 CFR . 8 872.3275 (b)
Devices for Which Substantial Equivalence is Claimed:
- Kerr Corporation, TempBond Clear .
Device Description:
TempBond Clear with Triclosan is a dual-cured, temporary, eugenol-free, resin-based cement with triclosan. This base/catalyst cement is flexible and transparent when cured. The device will be packaged in a dual-barrel syringe to eliminate hand mixing. It has excellent flow to permit the restoration to be easily and completely seated. It is strong enough to withstand the stresses of mastication, yet permits easy removal of the restoration when it is desired. TempBond Clear with Triclosan contains triclosan.
Intended Use of the Device:
The intended use of TempBond Clear with Triclosan is for the temporary cementation of temporary restorations such as crowns, bridges, inlays, onlays and splints.
Substantial Equivalence:
TempBond Clear with Triclosan is substantially equivalent to other legally marketed devices in the United States. This temporary dental cement which will be manufactured by Kerr Corporation functions in a manner similar to and is intended for the same use as the product currently marketed by Kerr.
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Sybron Dental Specialties 100 Bayview Circle, Suite 6000 Newport Beach, CA 92660-8915 800.537.7824 949.55.8700 www.sybrondental.com
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 department's name around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.
FEB 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 100 Bayview Circle, Suite 6000 Newport Beach, Califorina 92660
Re: K053565
Trade/Device Name: TempBond Clear with Triclosan Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: December 21, 2005 Received: December 22, 2005
Dear Ms. Boswell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -- Ms. Colleen Boswell
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chau S. Lin, PhD
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): |