(72 days)
Not Found
No
The document describes a composite resin system for creating provisional dental restorations and does not mention any AI or ML components or functionalities.
No
The device is a material used to create temporary dental restorations, not a device that treats or diagnoses a medical condition or disease.
No
The device description indicates it is a system used to create provisional dental restorations, not to diagnose a condition. Its intended use is for fabrication of restorations, not for diagnostic purposes.
No
The device description explicitly states it is a "visible light cured composite based resin and accessories," which are physical 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 clearly states the device is for fabricating provisional dental restorations. This is a direct treatment or restorative purpose, not a diagnostic one.
- Device Description: The description confirms it's a "visible light cured composite based resin and accessories used to create provisional restorations." This aligns with a material used for physical restoration, not for analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely restorative and temporary.
N/A
Intended Use / Indications for Use
The Modified TempRx Esthetic Provisional System is:
- · Indicated for the fabrication of all provisional dental restorations for a term of use of up to 6 months.
- · Indicated for fabrication of the following long-term provisional dental restorations (without metal substructures) for a term of use greater than 6 months up to 3 years:
- Inlays/ Onlays ■
- = Veneers
- Crowns
- 3-unit bridges through the 2nd bicuspid. 대
· Indicated for the build up of a tooth on denture base resins.
Product codes
EBG, EBD
Device Description
The Modified TempRx Esthetic Provisional System is a visible light cured composite based resin and accessories used to create provisional restorations for patients waiting for final prosthodonic restorations.
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
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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)
TempFx Esthetic Provisional System, K061264
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
APR 1 8 2008
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
| CONTACT: | Helen Lewis |
|---|---|
| DATE PREPARED: | February 4, 2008 |
| TRADE OR PROPRIETARY NAME: | Modified TempRx Esthetic Provsisional System |
| CLASSIFICATION NAME: | Temporary Crown and Bridge Resin, EBG, 872.3770 |
| PREDICATE DEVICES: | TempFx Esthetic Provisional System, K061264 |
DEVICE DESCRIPTION: The Modified TempRx Esthetic Provisional System is a visible light cured composite based resin and accessories used to create provisional restorations for patients waiting for final prosthodonic restorations.
INTENDED USE: The Modified TempRx Esthetic Provisional System is:
- · Indicated for the fabrication of all provisional dental restorations for a term of use of up to 6 months.
- · Indicated for fabrication of the following long-term provisional dental restorations (without metal substructures) for a term of use greater than 6 months up to 3 years:
- Inlays/ Onlays ■
- = Veneers
- Crowns
- 3-unit bridges through the 2nd bicuspid. 대
· Indicated for the build up of a tooth on denture base resins.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in Modified TempRx Esthetic Provisional System have been used in legally marketed devices and/or were found safe for dental use. Modified TempRx 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 Modified TempRx Esthetic Provisional System in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of the Modified TempRx Esthetic Provisional System for the indicated uses.
Premarket Notification
000010
1
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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Helen Lewis Director of Corporate Compliance & Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
APR 1 8 2008
Re: K080311
Trade/Device Name: Modified TempRx Esthetic Provisional System Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Codes: EBG, EBD Dated: February 4, 2008 Received: February 6, 2008
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.
2
Page 2- Ms. 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 (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 Parl 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,
Sayite H. Michau. Dds.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
6902
510(k) Number (if known):
Device Name: Modified TempRx Esthetic Provisonal System
Indications for Use:
The Modified TempRx Esthetic Provisional System is:
- · Indicated for the fabrication of all provisional dental restorations for a term of use of up to 6 months.
- · Indicated for fabrication of the following long-term provisional dental restorations (without metal substructures) for a term of use greater than 6 months up to 3 years:
- Inlays/ Onlays 체
- 보 Veneers
- 제 Crowns
- 3-unit bridges through the 2nd bicuspid. 트
· Indicated for the build up of a tooth on denture base resins.
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)
Suga Quaar
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K050311
000000