(88 days)
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 the study and for production of catestication study and for production of restorative prosthetic devices, such as gold inlays and dentures.
Novel Print Cyan Alginates
This appears to be a 510(k) clearance letter from the FDA for a dental impression material called "Novel Print Cyan Alginates." This document does not contain any information about acceptance criteria or a study proving device performance in the context of AI/ML or medical imaging algorithms.
The document is a regulatory approval for a physical dental product, confirming its substantial equivalence to a predicate device. It discusses the regulatory classification, general controls, and labeling requirements for the product.
Therefore, I cannot extract any of the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies because these concepts are not applicable to the content of this specific document.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a caduceus, which is a symbol often associated with healthcare.
SEP - 4 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Manufacturera Dental Continental C/O Mr. Gary Mocrik Official Correspondent Gary Mocnik & Associates 27881 La Paz Road, #G 316 Laguna Niguel, California 92677
Re : K011785
Trade/Device Name: Novel Print Cyan Alginates Regulation Number: 872.3660 Regulatory Class : II Product Code: ELW Dated: June 1, 2001 Received: June 8, 2001
Dear Mr. Mocnik:
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 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), 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 (Premarket Approval), 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 895. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulations. Facili action. In addition, FDA may publish further announcements
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Page 2 - Mr. Mocnik
concerning your device in the Federal Register. Please note: this response to your premarket notification submission hoes not affect any obligation you might have under sections 53c. through 542 of 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 maryen.
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) 594-4613. 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 807.97). Other general information on your responsibilities under the gctear 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 yours,
Timothy A. Ulatowski 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):
Device Name: Novel Print Cyan Alginates
Indication For Use:
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 the
study and for production of catestication study and for production of restorative prosthetic devices, such as gold 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_ Per 21 CFR 801.109 (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Pey 510(k) Number_
§ 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).