(63 days)
For the fabrication of temporary crowns and bridges until the permanent restoration can be delivered.
Not Found
The provided text is a 510(k) substantial equivalence determination letter from the FDA for a dental device called "Systemp.c&b Plus" (K042820). This type of document confirms that a new device is as safe and effective as a legally marketed predicate device.
Crucially, this document does NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications for a medical device AI/ML model.
Instead, it's a regulatory approval letter for a temporary crown and bridge resin, a material used in dentistry, not a diagnostic or AI-powered device. The content focuses on regulatory compliance, legal marketing, and general controls provisions of the Act.
Therefore, I cannot provide the requested information based on the provided text. The questions are relevant to the evaluation of AI/ML medical devices, which this document does not describe.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three overlapping, curved shapes that resemble an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2004
Ms. Donna Marie Hartnett Director of Quality Assurance/Regulatory Affairs Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228
Re: K042820
Trade/Device Name: Systemp.c&b Plus Regulation Number: 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: October 7, 2004 Received: October 13, 2004
Dear Mr. Hartnett:
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.
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Page 2 - Mr. Hartnett
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); 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. 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
510(k) Number (if known): K042826
Device Name: Systemp.c&b Plus Indications For Use:
Intended Use:
Intended Use:
For the fabrication of temporary crowns and bridges until the permanent restoration can be delivered.
AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of ____________________________________________________________________________________________________________________________________________________________________
spre SU Jen
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.