VERSYO.BOND

K033629 · Heraeus Kulzer, Inc. · EBI · Dec 22, 2003 · Dental

Device Facts

• Record ID: K033629
• Device Name: VERSYO.BOND
• Applicant: Heraeus Kulzer, Inc.
• Product Code: EBI · Dental
• Decision Date: Dec 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended 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.

Device Story

Versyo.bond is a light-curing, methyl methacrylate-free conditioner used in dental laboratories. It functions as an adhesive agent to facilitate the bonding of light-curing prosthetic base materials to PMMA-based denture components, including heat-cured, self-cured, or light-cured denture bases and artificial teeth. The device is applied by dental professionals during the fabrication or repair of dental prosthetics. By ensuring a chemical bond between the prosthetic base and the artificial teeth or base materials, it improves the structural integrity of the dental appliance, benefiting the patient by providing a more durable and reliable prosthetic.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-curing, methyl methacrylate-free chemical conditioner. Formulated for bonding light-curing prosthetic base materials to PMMA-based substrates. Class II device (Product Code EBI).

Indications for Use

Indicated for use as a conditioner to bond light-curing prosthetic base materials to heat, self, or light-curing PMMA denture base materials and PMMA-based artificial teeth.

Regulatory Classification

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.

Submission Summary (Full 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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