(56 days)
Not Found
Not Found
No
The summary describes a dental impression material, which is a physical substance and does not involve software or data processing typically associated with AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly "Not Found".
No.
The device is described as polysiloxane impression materials used prior to fabrication of crowns, bridges, and inlays. Its function is to create an impression, not to treat or cure a disease or condition, which is the domain of therapeutic devices.
No
The description states it is an impression material used prior to fabrication of dental restorations, not for diagnosing a condition.
No
The device description explicitly states it is "polysiloxane impression materials," which are physical materials, 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 create impressions for dental prosthetics (crowns, bridges, inlays). This is a physical process of capturing the shape of teeth and surrounding structures.
- Device Description: It's an impression material, which is a substance used to make a mold.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the diagnosis of diseases or conditions based on such analysis.
IVDs are typically used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment decisions. This device's function is purely mechanical in creating a physical impression.
N/A
Intended Use / Indications for Use
Honigum® Automix and Honigum® Quick are polysiloxane impression materials to be applied by the dental professional prior to fabrication of crowns, bridges and inlays for their patients.
Product codes
ELW
Device Description
Honigum® Automix and Honigum® Quick are polysiloxane impression materials.
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
dental professional
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a stylized eagle. The eagle is depicted with three overlapping lines forming its body and wings, giving it a modern and abstract appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 1 1998
Foremost Dental Mfg. Co., Incorporated C/O Ms. An-Shih Cheng Chenq & Associates, Incorporated 415 West Aldine Avenue, #10-A Chicago, Illinois 60657-3602
Re : K980963 Honigum® Automix Impression Material (Foil Trade Name: Bags) and Honigum® Quick Regulatory Class: II Product Code: ELW Dated: March 13, 1998 March 16, 1998 Received:
Dear Ms. An-Shih Cheng:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Ms. An-Shih Cheng
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Timothy A Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K980963/Ai
FDA/CDRH/ODE/DMC
Page of
3 / Har 99 1458
510(k) Number (if known): K980923
Honigum® Automix and Honigum® Quick Device Name:
Indications for Use:
Honigum® Automix and Honigum® Quick are polysiloxane impression materials to be applied by the dental professional prior to fabrication of crowns, bridges and inlays for their patients.
(PLEASE DO NOT WRITE BELOW THIS LINE---CONTINUE ON ANOTHER PAGE IF NEEDED) ##ee*************************************************************************************************************************************************************************
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number _
589
' '' '' '' '' '' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' Prescription Use × (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________