(54 days)
DMG, Luxatemp Automix Plus
Not Found
No
The description focuses on the chemical and physical properties of a dental restorative material and does not mention any computational or analytical capabilities that would suggest AI/ML.
No
A therapeutic device is used to treat or alleviate a medical condition. This device is a restorative material used for temporary crowns and bridges, which is a prosthetic application rather than a therapeutic treatment.
No
The device, Fill-In, is described as a restorative material for fabricating temporary crowns and bridges. Its purpose is to physically restore or replace dental structures, not to diagnose a condition or disease.
No
The device description clearly states it is a "chemically catalyzed, highly filled, resin-based restorative material" and a "two-component, catalyst and base, material dispensed and mixed". This describes a physical material, 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 to "fabricate short and long term crown and bridge temporaries." This is a direct application within the patient's mouth (or on a model of the patient's mouth), not for testing samples taken from the body.
- Device Description: The description details a material used for creating temporary dental restorations. It's a physical material used in a dental procedure.
- 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 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 Fill-In is to be used to fabricate both short and long term crown and bridge temporaries.
Fill-In is a chemically catalyzed, highly filled, resin-based restorative material used to fabricate short and long term crown and bridge temporaries.
Product codes
EBG
Device Description
Fill-In temporary crown and bridge material is a two-component, catalyst and base, material dispensed and mixed in both Unidose™, single use syringe, and cartridge delivery. Fill-In is intended for use in both short and long term crown and bridge temporaries. The material is compatible with light cured composites for repair and characterization. Fill-In contains methacrylate components and is radiopaque for easy radiographic identification.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
DMG, Luxatemp Automix Plus
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
Image /page/0/Picture/0 description: The image shows a document with the date July 2, 2003, at the top. Below the date is the logo for "sds". The text "SYBRON DENTAL SPECIALTIES" is printed below the logo. The document is titled "Section III - 510(k) Summary of Safety and Effectiveness".
031476
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: May 2003
Device Name:
- Trade Name Fill-In .
- 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:
- DMG, Luxatemp Automix Plus .
Device Description:
Fill-In temporary crown and bridge material is a two-component, catalyst and base, material dispensed and mixed in both Unidose™, single use syringe, and cartridge delivery. Fill-In is intended for use in both short and long term crown and bridge temporaries. The material is compatible with light cured composites for repair and characterization. Fill-In contains methacrylate components and is radiopaque for easy radiographic identification.
Intended Use of the Device:
The intended use of Fill-In is to be used to fabricate both short and long term crown and bridge temporaries.
Substantial Equivalence:
Fill-In is substantially equivalent to other legally marketed devices in the United States. Fill-In functions in a manner similar to and is intended for the same use as Luxatemp Automix Plus that is manufactured by DMG.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 2003 JUL
4 2003
Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92867
Re: K031476
Trade/Device Name: FILL-INTM Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Codes: EBG Dated: May 07, 2003 Received: May 09, 2003
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.
2
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours.
Susan Munro
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Section I
Indications for Use Statement
Ver/ 3 - 4/24/96 Applicant: Kerr Dental Materials Center KO3 476 510(k) Number (if known): Device Name: Fill-In Indications For Use: Fill-In is a chemically catalyzed, highly filled, resin-based restorative material used to fabricate short and long term crown and bridge temporaries. Division Sinn. ivision of Anesthesiolog Infection Control. Denta 510(k) Number: (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96)