(221 days)
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No
The summary describes a CAD/CAM system for fabricating dentures using digital impressions and additive printing, which is a digital manufacturing process, not AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is a material (resin) for fabricating and repairing dental prosthetics, which is a structural rather than a therapeutic function. Therapeutic devices are typically used for treatment, diagnosis, or prevention of disease.
No
The device is a material (light-curable resin) used for fabrication and repair of dental prosthetics, not for diagnosing conditions.
No
The device description explicitly states it includes a stereolithographic additive printer and curing light equipment, which are hardware components.
Based on the provided information, DENTCA Denture Base II is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens taken from the human body. The intended use of DENTCA Denture Base II is for the fabrication and repair of dental prosthetics (dentures and baseplates). This involves working with materials that will be placed in the body, but not analyzing biological samples from the body.
- The description focuses on the material and the manufacturing process. It describes a light-curable resin used with a CAD/CAM system, printer, and curing light. This is a manufacturing process for a medical device, not a diagnostic test.
- There is no mention of analyzing biological samples. The input is a "digital impression," which is a digital representation of the patient's oral anatomy, not a biological specimen like blood, urine, or tissue.
Therefore, DENTCA Denture Base II falls under the category of a medical device used for fabrication, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
DENTCA Denture Base II is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins.
Fabrication of dental prosthetics with Dentca Denture a computer-aided design and manufacturing (CAD/ CAM) system that includes the following components: digital denture base files based on a digital impression, stereolithographic additive printer, and curing light equipment.
Product codes
EBI
Device Description
DENTCA Denture Base II is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental prosthetics with Dentca Denture a computer-aided design and manufacturing (CAD/ CAM) system that includes the following components: digital denture base files based on a digital impression, stereolithographic additive printer, and curing light equipment.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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
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§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 3, 2017
Dentca, Inc. % Mr. Claude Berthoin President 510(k) FDA Consulting 100 East Granada Blvd., Suite 219 Ormond Beach, Florida 32176
Re: K160244
Trade/Device Name: Dentca Denture Base II Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: December 26, 2016 Received: January 3, 2017
Dear Mr. Berthoin:
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. 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.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Susan Runner DDS, MA
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160244
Device Name Dentca Denture Base II
Indications for Use (Describe)
DENTCA Denture Base II is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins.
Fabrication of dental prosthetics with Dentca Denture a computer-aided design and manufacturing (CAD/ CAM) system that includes the following components: digital denture base files based on a digital impression, stereolithographic additive printer, and curing light equipment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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