(84 days)
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Not Found
No
The provided text describes a dental bonding agent and does not mention any AI or ML technology.
No
The device is a bonding agent used in dental restorations and does not directly treat or alleviate a disease or condition.
No
The provided text describes the intended use of Futurabond DC/Single Dose for dental restorations and bonding, which are treatment procedures, not diagnostic ones.
No
The provided text describes a dental bonding agent (Futurabond DC/Single Dose) which is a chemical substance, not a software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's application in dental procedures for bonding and restoring teeth. This is a direct application within the body or on the body, not for testing samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays for testing
Therefore, based solely on the provided text, Futurabond DC/Single Dose is a dental material used in restorative procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Futurabond DC/Single Dose is intended for direct self- or dual curing composite restaurations and core build-ups, direct light-curing composite/compomer/ormocer-based restaurations, fixing root pins/posts with dual- or self-curing composite cements, indirect restaurations with the application of dual-curing composite cements for bonding inlays, onlays, crowns and bridges.
Product codes
KLE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, clutching what appears to be a caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Thorsten Gerkensmeier Regulatory Affairs VOCO GmbH Anton-Flettner-Strasse 1-3 Cuxhaven, Germany 27472
JUN - 7 2007
Re: K070723
Trade/Device Name: Futurabond DC/Single Dose Regulation Number: 872.3200 Regulation Name: Resin Teeth Bonding Agent Regulatory Class: II Product Code: KLE Dated: March 13, 2007 Received: March 15, 2007
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, 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.
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 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" (21CFR 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,
Sybil Y. Michael MD
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
2
Indications for Use Statement
510(k) Number: K070723
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Futurabond DC/Single Dose is intended for direct self- or dual curing composite restaurations and core build-ups, direct light-curing composite/compomer/ormocer-based restaurations, fixing root pins/posts with dual- or self-curing composite cements, indirect restaurations with the application of dual-curing composite cements for bonding inlays, onlays, crowns and bridges.
Prescription Use X
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)
Susa Runser
Sign-Off)
ision of Anesthesiology, General Hospital
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
K01013