(33 days)
Versyo.bond is light curing, methyl methacrylate free conditioner for the bonding of light curing prosthetic base materials to heat, self or light curing PMMA denture base materials and artificial teeth based on PMMA.
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I am sorry, but based on the provided document, I cannot fulfill your request. The document is a 510(k) premarket notification approval letter for a dental bonding agent named "Versyo®.bond". It confirms the device's substantial equivalence to a legally marketed predicate device and outlines regulatory compliance requirements.
However, the document does not contain any information about clinical studies, performance data, acceptance criteria, sample sizes, ground truth establishment, or expert qualifications. The approval letter is a regulatory document, not a scientific study report.
Therefore, I cannot extract the specific details you've requested regarding acceptance criteria and a study proving device performance because that information is not present in the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 2003
Ms. Cheryl V. Zimmerman Manager, Quality Operations and Compliance Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614
Re: K033629
Trade/Device Name: Versyo®.bond Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: November 17, 2003 Received: November 24, 2003
Dear Ms. Zimmerman:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) presidentially equivalent (for the indications for referenced above and have delemined the devices marketed in interstate comments, or to devices that use stated in the enclosure) to legally mankeed president Device Amendments, or to devices that prior to May 28, 1976, the chacinent date of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Featlestion (PMA). You may have been reclassified in accordance with the premations wal application (PMA). You may,
Act (Act) that do not require approval of a premarket approval approval of the Act. Act (Act) that do not require approval or a prematiconsplay of the Act. The general therefore, market the device, subject to the general one on anyal registration, listing of devices, good
controls provisions of the Act include requirements for annual regis controls provisions of the Act merade requirements against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into Englishing major regulations affecting your device can be may be subject to such additions, Title 21, Parts 800 to 898 . In addition, FDA may publish
found in the Code of Federal Regulations, Title 21, Parts 800 to 898 . found in the Code of I cachar regar your device in the Federal Register.
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Page 2 - Ms. Cheryl V. Zimmerman
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 It you added 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) you may obtain. 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Clus
Chiu S. Lin. PhD 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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Page 1 of
K033629 510(k) Number (if Known):
Device Name: Veryso.bond
Indications For Use:
Versyo.bond is light curing, methyl methacrylate free conditioner for the bonding of light curing prosthetic base materials to heat, self or light curing PMMA denture base materials and artificial teeth based on PMMA.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use _
(Optional Format 1-2-96)
Susan Rumpp
OR
Anesthesiology, G neral Hospital. Control, Dent
510(k) Number: K033129
§ 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.