(18 days)
Not Found
No
The summary describes a material system for creating provisional dental restorations and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used to fabricate provisional dental restorations, which are used to restore a physiological function (dental structure) temporarily while awaiting a final restoration. This falls under the definition of a therapeutic device.
No
The device is described as a system for fabricating provisional dental restorations, indicating it is a therapeutic or restorative device, not one used for diagnosis.
No
The device description explicitly states it includes "visible light cured resin based composites and accessories," which are physical materials and components, 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 the "fabrication of provisional dental restorations." This is a direct application within the patient's mouth (or on models of the patient's mouth), not for testing samples taken from the body.
- Device Description: The device is described as "visible light cured resin based composites and accessories used to create provisional restorations." This aligns with materials used for dental procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to create a physical dental restoration.
N/A
Intended Use / Indications for Use
TEMPFX ESTHETIC PROVISIONAL SYSTEM is indicated for fabrication of provisional dental restorations.
Product codes
EBG
Device Description
The TEMPFX ESTHETIC PROVISIONAL SYSTEM includes visible light cured resin based composites and accessories used to create provisional restorations for patients awaiting final prosthodontic restoration.
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)
The device has been evaluated and passed biocompatibility testing for cytotoxicity, mutagenicity, dermal sensitization and irritation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(k) SUMMARY
MAY 2 3 2006
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
| CONTACT: | Helen Lewis |
|---|---|
| DATE PREPARED: | May 1, 2006 |
| TRADE OR PROPRIETARY NAME: | TEMPFX ESTHETIC PROVISIONAL SYSTEM |
| CLASSIFICATION NAME: | Temporary crown and bridge resin, 872.3770 |
| PREDICATE DEVICES: | New Triad VLC Crown & Bridge Provisional |
| Material, K904251 |
DEVICE DESCRIPTION:
The TEMPFX ESTHETIC PROVISIONAL SYSTEM includes visible light cured resin based composites and accessories used to create provisional restorations for patients awaiting final prosthodontic restoration.
INTENDED USE:
TEMPFX ESTHETIC PROVISIONAL SYSTEM is indicated for fabrication of provisional dental restorations.
TECHNOLOGICAL CHARACTERISTICS:
All of the components found in TEMPFX ESTHETIC PROVISIONAL SYSTEM have been used in legally marketed devices and/or were found safe for dental use. TEMPFX ESTHETIC PROVISIONAL SYSTEM has been evaluated and passed biocompatibility testing for cytotoxicity, mutagenicity, dermal sensitization and irritation.
We believe that the prior use of the components of TEMPFX ESTHETIC PROVISIONAL SYSTEM in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of the TEMPFX ESTHETIC PROVISIONAL SYSTEM for the indicated use.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping birds in flight, rendered in black.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2006
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K061264
Trade/Device Name: TempFX Esthetic Provisional System Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: May 01, 2006 Received: May 05, 2006
Dear Ms. Lewis:
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. Helen Lewis
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 (OS) 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.
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):
TEMPFX ESTHETIC PROVISIONAL SYSTEM Device Name:
11061264
Indications for Use:
TEMPFX ESTHETIC PROVISIONAL SYSTEM is indicated for fabrication of provisional dental restorations.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
... of Anachesiology, General Hospits),
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