(115 days)
Not Found
Not Found
No
The provided text describes a dental adhesive and its various applications. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as an adhesive and varnish used in dental restorations and treatments, which are not considered therapeutic actions.
No
Explanation: The provided text describes "Futurabond Universal" as an adhesive for various dental restoration procedures and treatments. Its intended uses are therapeutic (bonding, sealing, repairing, treating hypersensitive necks) rather than diagnostic (identifying or detecting a medical condition).
No
The intended use describes a dental adhesive, which is a physical material applied to teeth. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended uses listed for Futurabond Universal are all related to dental procedures performed directly on the tooth (an anatomical site).
- The intended uses describe a material used in dental restorations and treatments. This is a therapeutic or restorative function, not a diagnostic one.
The description clearly indicates a dental adhesive used in various procedures within the mouth, not a test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
Futurabond Universal is intended for use as:
- Adhesive for direct restorations of all classes of cavities using light-curing composite/compomer/Ormocer materials with a methacrylate base
- Adhesive for core build-ups made of light-curing composite materials
- Adhesive for indirect restorations with light-curing luting composites.
- Intracral repair of composite, compomer or Ormocer restorations, ceramic veneers and all ceramic restorations without an additional primer
- Treatment of hypersensitive tooth necks
- Protective vamish for glass ionomer cement restorations
- Sealing of cavities prior to amalgam restorations
- Sealing of cavities and core preparations prior to the temporary luting of indirect restorations
- Adhesive for direct self-curing or dual-curing composite restorations of all classes of cavities and for core build-ups
- Adhesive for indirect restorations using dual-curing or self-curing luting composites
- Luting of root posts with dual-curing or self-curing luting composites
Product codes
KLE, EMA
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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
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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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2013
Dr. Thorsten Gerkensmeier Regulatory Affairs VOCO GmbH Anton-Flettner-Strasse 1-3 D-27472 Cuxhaven GERMANY
Re: K130486
Trade/Device Name: Futurabond U Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE, EMA Dated: April 16, 2013 Received: April 24, 2013
Dear Dr. Gerkensmeier:
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. Iisting 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.
1
Page 2 - Dr. Gerkensmeier
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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 of medical devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 ﻠ (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Susan Runner DDS, MA Mary S.
Runner--S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Futurabond Universal Device Name:
Indications for Use:
ないです。このことを経営すると、ここではな
Futurabond Universal is intended for use as:
- Adhesive for direct restorations of all classes of cavities using light-curing composite/compomer/Ormocer materials with a methacrylate base
- Adhesive for core build-ups made of light-curing composite materials
- Adhesive for indirect restorations with light-curing luting composites .
- Intracral repair of composite, compomer or Ormocer restorations, ceramic veneers and all ceramic restorations without an additional primer
- Treatment of hypersensitive tooth necks
- Protective vamish for glass ionomer cement restorations
- Sealing of cavities prior to amalgam restorations
- Sealing of cavities and core preparations prior to the temporary luting of indirect restorations
- Adhesive for direct self-curing or dual-curing composite restorations of all classes of cavities and for core build-ups
- Adhesive for indirect restorations using dual-curing or self-curing luting composites
- Luting of root posts with dual-curing or self-curing luting composites
Prescription Use × OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Andrew I. Steen 2013.06.20 08:46:34 04'00'
(Division Sign-Off) (Division of Anesthesloiogy, General Hospital Infection Control, Dental Devices
510(k) Number: K130486