(80 days)
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No
The 510(k) summary describes a dental impression material, which is a physical substance used to create molds. There is no mention of software, algorithms, or any computational processing that would indicate the use of AI or ML.
No.
The device is a dental impression material used to reproduce the structure of teeth and gums for models, not for direct therapeutic treatment.
No
This device is a dental impression material used to reproduce the structure of teeth and gums, and to provide models for study and for the production of restorative prosthetic devices. It is not used to diagnose a medical condition.
No
The device is a dental impression material, which is a physical substance, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or to monitor health. Examples include blood tests, urine tests, and genetic tests.
- This device is a dental impression material. Its purpose is to create a physical mold of a patient's teeth and gums. This mold is then used for study or to create dental prosthetics. It does not involve the examination of bodily fluids or tissues for diagnostic purposes.
The intended use clearly describes a physical process of creating an impression, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
Zhermack Elite Monophase is a dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. It is also intended to provide models for study and for the production of restorative prosthetic devices, such as dental inlays and dentures.
Product codes
ELW
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
patient's teeth and gums
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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PEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gerald Shipps Regulatory Affairs Consultant Cascades Device Consulting Associates 19379 Blue Lake Loop Bend, Oregon 97702
Re: K022653
Trade/Device Name: ELITE MONOPHASE Tray Material/ Maxi Tray Material, Medium Viscosity/ Maxi Monophase, Low Viscosity Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: August 6, 2002 Received: August 9, 2002
Dear Mr. Shipps:
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.
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.
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Page 2 - Mr. Shipps
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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
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
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Indications for Use Statement
510(k) Number: K022653
Device Name: ELITE MONOPHASE Tray Material/Maxi Tray Material, Medium Viscosity/Maxi Monophase, Low Viscosity
Indications for Use: Zhermack Elite Monophase is a dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. It is also intended to provide models for study and for the production of restorative prosthetic devices, such as dental inlays and dentures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓ OR Over-The-Counter Use __
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number ..
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