(11 days)
Not Found
No
The document describes a dental material and its intended use, with no mention of AI or ML technology.
No
The device is a temporary dental material used for fabricating crowns and bridges, which is a restorative rather than a therapeutic function.
No
The device is a temporary crown and bridge material used for restorative procedures, not for diagnosing medical conditions.
No
The device description clearly states it is a "two-component, methacrylate-based material," which is a physical substance, 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 "direct fabrication of TEMPORARY CROWN AND BRIDGE nlays, crowns or bridges used in indirect restorative procedures." This describes a material used in the mouth for dental restorations, not for testing samples outside the body to diagnose or monitor a medical condition.
- Device Description: The description mentions a "two-component, methacrylate-based material" and a "unit dose delivery system." This aligns with a dental material used for fabrication, not a diagnostic test.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or screening of a disease or condition.
Therefore, the TEMPORARY CROWN AND BRIDGE MATERIAL is a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TEMPORARY CROWN AND BRIDGE MATERIAL is indicated for direct fabrication of TEMI ORAN - ONO 177 veneers, inlays, onlays, crowns or bridges used in indirect restorative procedures.
Product codes
EBG
Device Description
The TEMPORARY CROWN AND BRIDGE MATERIAL is a two-component, methacrylate-based material. The volume mix of this automixed material is a 1:1 ratio. The unit dose delivery system matchui. "The votential risks associated with asepsis and the need for disinfection.
The TEMPORARY CROWN AND BRIDGE MATERIAL is a self-curing, provisional material that is initiated by mixing the catalyst and base. The material is composed of methacrylates, that is intracted of minute stabilizer. And a stabilizer. All of the components found in TEMPORARY CROWN AND BRIDGE MATERIAL have been used in legally marketed I ENI ORIN'T ENO WE's for dental use. We believe that the prior use of the components in devices or were roans bare bate provided, and the biocompatibility data provided legary manced do recor, and effectiveness of TEMPORARY CROWN AND BRIDGE MATERIAL for the indicated uses.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Luxatemp Automix, K924830
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.
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FEB 17 2006
510(k) SUMMAR
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
| CONTACT: | Helen Lewis |
|---|---|
| DATE PREPARED: | February 2, 2006 |
| TRADE OR PROPRIETARY NAME: TEMPORARY CROWN AND BRIDGE MATERIAL | |
| CLASSIFICATION NAME: | Temporary crown and bridge resin. 872.3770 |
| PREDICATE DEVICES: | Luxatemp Automix, K924830 |
DEVICE DESCRIPTION:
The TEMPORARY CROWN AND BRIDGE MATERIAL is a two-component, methacrylate-based material. The volume mix of this automixed material is a 1:1 ratio. The unit dose delivery system matchui. "The votential risks associated with asepsis and the need for disinfection.
INTENDED USE:
TEMPORARY CROWN AND BRIDGE MATERIAL is indicated for direct fabrication of TEMI ORAN - ONO 177 veneers, inlays, onlays, crowns or bridges used in indirect restorative procedures.
TECHNOLOGICAL CHARACTERISTICS:
The TEMPORARY CROWN AND BRIDGE MATERIAL is a self-curing, provisional material that is initiated by mixing the catalyst and base. The material is composed of methacrylates, that is intracted of minute stabilizer. And a stabilizer. All of the components found in TEMPORARY CROWN AND BRIDGE MATERIAL have been used in legally marketed I ENI ORIN'T ENO WE's for dental use. We believe that the prior use of the components in devices or were roans bare bate provided, and the biocompatibility data provided legary manced do recor, and effectiveness of TEMPORARY CROWN AND BRIDGE MATERIAL for the indicated uses.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
FEB 1 7 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Helen Lewis Mis. Helon Bornb
Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K060293
K000295
Trade/Device Name: Temporary Crown and Bridge Material Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: February 03, 2006 Received: February 06, 2006
Dear Ms. Lewis:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(K) prematically equivalent (for the indications for referenced above and nave decemblicated predicated wices marketed in interstate commerce
use stated in the enclosure) to legally market devices markeers, or to devices that use stated in the enclosure) to legally hianced president of the Amendments, or to devices that prior to May 28, 1976, the elacinent vals of the Miscon of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the PRA ) . You ma have been reclassified in accordance with the premations wal application (PMA). You may,
Act (Act) that do not require approval of a premarket approval application of the ge Act (Act) that do not require approval or a promatics apply on of the Act. The general therefore, market the device, subject to mis general sons and registration, listing of devices, good
controls provisions of the Act include requirements for anyisheseding and controls provisions of the Act metade requirements as and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) more courtes and consections affecting your device can be
may be subject to such additional controls. Existing major regulations FDA may be subject to such additions, Title 21, Parts 800 to 898 . In addition, FDA may publish found in the Code of I cacral resguinted in the Federal Register.
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Page 2 - Ms. Helen Lewis
- Sales and the same
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised mar 1 271 s issualled to but device complies with other requirements of the Act or that FDA nas made a decemination allery sistered by other Federal agencies. You must comply with ally rederal statutes and regulations as and not limited to: registration and listing (21 CFR Part 807); all the ACT s requirements, morading, butacturing practice requirements as set forth in the quality labeling (21 CFR Part 820); and if applicable, the electronic product radiation systems (QD) regallers (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) I his letter wif anow you to ough mating of substantial equivalence of your device to a legally prematics notification. - The PDF 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 If you desire specific acries is your 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 general internation on your 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,
Suca Ranses
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):
TEMPORARY CROWN AND BRIDGE MATERIAL -Device Name:
Indications for Use:
TEMPORARY CROWN AND BRIDGE MATERIAL is indicated for direct fabrication of TEMFORANT CROWN THD BRIDGE nlays, crowns or bridges used in indirect restorative procedures.
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)
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