(46 days)
SPECTRA FORM™ Chromatic Alginate Impression Material is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.
SPECTRA FORM™ Chromatic Alginate Impression Material is a color-changing alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to off-white indicating the end of the setting time in the mouth.
This document is a 510(k) premarket notification letter from the FDA regarding an alginate impression material. It does not contain information about acceptance criteria or a study proving device performance in the context of AI or software. The letter is a regulatory document confirming substantial equivalence to a predicate device for a physical dental impression material.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance using the provided text. The document does not discuss:
- Acceptance criteria and reported device performance
- Sample size and data provenance for a test set
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study or human reader improvement with AI
- Standalone (algorithm-only) performance
- Type of ground truth used (e.g., pathology, outcomes data)
- Sample size for the training set
- How ground truth for the training set was established
The provided text is a regulatory clearance for a dental material and does not involve AI/software performance studies.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
। 1898 MAY
Mr. Bernard Van Dujin ·Manager, Technical Services Cavex Holland B.V. Harmenjansweg 19-21 P.O. Box 852 2003 RW Haarlem THE NETHERLANDS
K980965 -Re : Spectra Form Chromatic Alginate Impression Trade Name: Material Requlatory Class: II ELW Product Code: Dated: March 13, 1998 Received: March 16, 1998
Dear Mr. Bernard Van Dujin:
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 ----requlations 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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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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,
K. Chilton
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) NUMBER (IF KNOWN) : K980965
DEVICE NAME: SPECTRA FORM™ Chromatic Alginate Impression Material
INDICATIONS FOR USE:
SPECTRA FORM™ Chromatic Alginate Impression Material is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc.
SPECTRA FORM™ Chromatic Alginate Impression Material is a color-changing alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to off-white indicating the end of the setting time in the mouth.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Over-The-Counter-Use (Optional Format 1-2-96)
Sason Kunes
(Division Sign-Off) Division of Dental, Infection Control. and General Hospital Device 510(k) Number
OR
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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).