(89 days)
TempFlex is indicated for the fabrication of temporary crowns and bridges, inlays, onlays and veneers.
TempFlex is a two component resin based material dispensed and mixed by a cartridge/static mixing tip combination. TempFlex is compatible with light cured composites for repair and characterization.
The document describes the submission of a 510(k) premarket notification for a dental device called TempFlex. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the typical format of a clinical or performance study with defined metrics.
Instead, the submission focuses on demonstrating substantial equivalence to an existing legally marketed predicate device (Temphase) based on non-clinical test data.
Here's an attempt to structure the information based on your request, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Compared to Predicate) |
|---|---|
| Biocompatibility ISO 10993 | Meets ISO 10993 standards (demonstrates safety for intended use) |
| Working Time (Comparable to predicate) | Bench tested against Temphase |
| Setting Time (Comparable to predicate) | Bench tested against Temphase |
| Compressive Strength (Comparable to predicate) | Bench tested against Temphase |
| Diametral Strength (Comparable to predicate) | Bench tested against Temphase |
| Flexural Strength (Comparable to predicate) | Bench tested against Temphase |
| Shore D Hardness (Comparable to predicate) | Bench tested against Temphase |
Note: The document does not provide specific numerical acceptance criteria (e.g., "Working Time must be X +/- Y minutes") or the exact numerical results for TempFlex and the predicate device. It only states that these characteristics were "evaluated" and used to support substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified for any of the bench tests (Working Time, Setting Time, Compressive Strength, etc.).
- Data Provenance: The studies were non-clinical bench tests. No specific country of origin is mentioned for the data, but the company is based in California, USA. The data is implicitly retrospective in the sense that it was generated for this regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. The "test set" for this submission consists of material properties measured via bench testing, not clinical data requiring expert assessment for ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. As per point 3, this was bench testing of material properties, not clinical data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. The document explicitly states: "Clinical testing has not been conducted on this product." Therefore, no MRMC study was performed.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a dental material, not an algorithm or AI system.
7. The Type of Ground Truth Used
- For Biocompatibility: Adherence to ISO 10993 standards.
- For Performance Characteristics (Working Time, Setting Time, etc.): Comparison to the predicate device (Temphase)'s performance, as measured through standard laboratory bench tests. The predicate's established performance serves as the "ground truth" for demonstrating substantial equivalence.
8. The Sample Size for the Training Set
- Not Applicable. This is a dental material, not a machine learning model. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As per point 8.
Summary of Device and Study:
The device, TempFlex, is a two-component resin-based material for temporary dental restorations. The study presented in the 510(k) submission is a non-clinical bench study designed to establish substantial equivalence to an existing legally marketed device (Temphase).
Substantial equivalence was demonstrated by:
- Confirming biocompatibility according to ISO 10993 standards.
- Evaluating and comparing key performance characteristics (Working Time, Setting Time, Compressive Strength, Diametral Strength, Flexural Strength, and Shore D Hardness) of TempFlex against the predicate device, Temphase, through bench testing.
No clinical testing, human reader studies, or AI/software evaluations were performed or reported in this submission. The regulatory pathway chosen relied on demonstrating that the new device's material properties and safety profile were comparable to a predicate device already on the market.
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Section III - 510(k) Summary of Safety and Effectiveness
JUN 1 4 2011
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7472 - Facsimile Wendy Garman - Contact Person
Date Summary Prepared: March 2011
Device Name:
- Trade Name TempFlex ●
- Common Name Temporary Dental Restorative Material .
- Classification Name Temporary Crown and Bridge Resin, per 21 CFR § 872.3770 .
Devices for Which Substantial Equivalence is Claimed:
- Kerr Corporation, Temphase .
Device Description:
TempFlex is a two component resin based material dispensed and mixed by a cartridge/static mixing tip combination. TempFlex is compatible with light cured composites for repair and characterization.
Intended Use of the Device:
TempFlex is indicated for the fabrication of temporary crowns and bridges, inlays, onlays and veneers.
Substantial Equivalence:
TempFlex is substantially equivalent to one other legally marketed device in the United States. TempFlex functions in a manner similar to and is intended for the same use as Temphase which is currently marketed by Kerr Corporation. TempFlex differs from
800-537-7824 714-516-7400 1717 West Collins Avenve, Orange, CA 92867
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Temphase in that it utilizes a different initiator system including the addition of a photoinitiator allowing the product to be dual cured and is available in a 4:1 mixing ratio. 2115141
Non-Clinical Test Data
Biocompatibility studies have been completed according to ISO 10993, which demonstrates that TempFlex is safe for its intended use.
This 510(k) submission also includes data from bench testing used to evaluate the performance characteristics of TempFlex compared to the predicate device, Temphose. The characteristics evaluated include Working Time, Setting Time, Compressive Strength, Diametral Strength, Flexural Strength and Shore D Hardness.
Clinical Testing
Clinical testing has not been conducted on this product.
Conclusion:
Based upon the biocompatibility tests and the bench testing, the clinical performance of TempFlex is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem featuring a stylized caduceus, a symbol often associated with healthcare and medicine. The caduceus consists of a staff with two snakes coiled around it and wings at the top.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Kerr Corporation C/O Ms. Wendy Garman Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
JUN 1 4 201
Re: K110747
Trade/Device Name: TempFlex Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: May 6, 2011 Received: May 9. 2011
Dear Ms. Garman:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Garman
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
for
Anthony D. Watson, B.S., M.S., M.B.A. 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): K110747
Device Name: TempFlex
Indications For Use:
. TempFlex is indicated for the fabrication of temporary crowns and bridges, inlays, onlays and veneers.
X Prescription Use __ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K110747 |
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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.