(77 days)
Not Found
Not Found
No
The summary describes a dental filling material and does not mention any software, image processing, or AI/ML terms.
No
The device is a filling material for teeth and is not intended for the treatment, diagnosis, or prevention of a disease or condition.
No
The device is described as a "filling material for restoring function to teeth" due to caries, which indicates it is a therapeutic or restorative device, not a diagnostic one.
No
The intended use describes a filling material, which is a physical substance used in dentistry, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a filling material for restoring function to teeth. This is a direct treatment applied to the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator of whether a device is an IVD.
- Mentions image processing, AI, DNN, ML, Input Imaging Modality: None of these are mentioned, which are often associated with IVD devices that analyze images or data for diagnostic purposes.
- Anatomical Site: The anatomical site is "teeth," which is where the material is applied directly.
- Intended User: The intended user is a "dental professional," who applies the material directly to the patient.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
MICROHYBRID 12 is to be used as a filling material for restoring function to teeth which have lost portions due to caries: IDirect, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV Class V restorations, cervical caries, root erosion, wedge shaped defects. Posterior restorations, Class I, II. Splinting of mobile teeth. Preventive restorations in molars and premolars. Repair of composite and ceramic veneers. Inlavs/onlays with extra-oral post tempering
Product codes
EBF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professional such as DDS or DMD.
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): 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.
Not Found
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.
Not Found
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).
Not Found
§ 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
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
NOV 22 2002
AB Ardent C/O Mr. Clyde E. Ingersoll Ardent Product Development 54 Riverview Avenue Tonawanda, New York 14150-5260
Re: K022974
Trade/Device Name: MICROHYBRID 12 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 vour 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 - 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 (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 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 vours.
Patrice Cucinello
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
AB ARDENT
Generatorgatan 8
S. 195 60 Marsta.
K022974
S'vederi
Phone +046 8 591 210 20
FAX +046 8 591 161 83
MICROHYBRID 12 ATTACHMENT #4
INDICATIONS FOR USE
ludications:
MICRCHYBRID 12 is to be used as a filling material for restoring function to teeth which have lost portions due to caries:
IDirect, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV
Class V restorations, cervical caries, root erosion, wedge shaped defects.
Posterior restorations, Class I, II.
Splinting of mobile teeth.
Preventive restorations in molars and premolars.
Repair of composite and ceramic veneers.
Inlavs/onlays with extra-oral post tempering
( :ontra indications:
1 he pliacement of Microhybrid 12 is contraindicated
If a dry working field cannot be established or if the stipulated technique cannot the applied.
If the patient is known to be allergic to the components of Microhybrid 12.
I or use only by dental professional such as DDS or DMD. Not for use by general public or OTC.
Dr. Robert Betz for Dr. Susan Kummer
n of Anesthesidlogy, General Hospital. Infection Control, Dental Devices
510(k) Number: K022974