(77 days)
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No
The summary describes a dental filling material and its intended uses, with no mention of AI, ML, image processing, or any computational analysis of data.
No
The device is a dental filling material used for restoring teeth, not for treating diseases or health conditions.
No
Explanation: The device is described as a "filling material for restoring function to teeth" and is used for various dental restorations. Its intended use is therapeutic (restoring) rather than diagnostic (identifying or detecting a condition).
No
The device is described as a "filling material" for restoring teeth, 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 describes the device as a filling material for restoring teeth. This is a direct treatment applied to the patient's body (in this case, their teeth).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
The description clearly indicates a material used in vivo (within the living body) for restorative purposes, not a test performed in vitro (outside the living body) on a sample.
N/A
Intended Use / Indications for Use
MICROFILL 13 is to be used as a filling material for restoring function to teeth that have lost portions due to caries:
Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV and V Corrections of anomalies such as peg shaped teeth Splinting of mobile anterior teeth. Repair of resin and ceramic veneers. Reconstruction of anterior trauma cases Veneering of discolored anterior teeth
Product codes (comma separated list FDA assigned to the subject device)
EBF
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
teeth
Indicated Patient Age Range
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Intended User / Care Setting
dental professional such as DDS or DMD. Not for use by general public or OTC.
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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§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
od and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AB Ardent C/O Mr. Clyde E. Ingersoll Ardent Product Development 54 Riverview Avenue Tonawanda, New York 14150-5260
Re: K022972
Trade/Device Name: Microfill 13 Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 5, 2002 Received: September 6, 2002
Dear Mr. Ingersoll:
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.
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Page 2 - Mr. Ingersoll
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,
Patricia Cucente / fte
Timothy A. Ulatowski 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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AB ARDENT
Generatorgatan 8 S-195 60 Marsta Sweden Phone +046 8 591 210 20 +046 8 591 161 83 FAX
510 (k MICROFILL 13 ATTACHMENT #4
INDICATIONS FOR USE
Indications:
MICROFILL 13 is to be used as a filling material for restoring function to teeth that have lost portions due to caries:
Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV and V Corrections of anomalies such as peg shaped teeth Splinting of mobile anterior teeth. Repair of resin and ceramic veneers. Reconstruction of anterior trauma cases Veneering of discolored anterior teeth
Contra indications:
The placement of Microfill 13 is contraindicated
If a dry working field cannot be established or if the stipulated technique cannot be applied.
If the patient is known to be allergic to the components of Microfill 13.
For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.
Robert Batz, DDS for Dr. Susan Kuemer
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology General Hospital, Infection Control. Dental Devices
510(k) Number: K022972