VERSYO.DIRECT

K043295 · Heraeus Kulzer, Inc. · EBI · Jan 5, 2005 · Dental

Device Facts

• Record ID: K043295
• Device Name: VERSYO.DIRECT
• Applicant: Heraeus Kulzer, Inc.
• Product Code: EBI · Dental
• Decision Date: Jan 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

Versyo.direct is a 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.direct is a light-curing, methyl methacrylate-free conditioner; functions as a bonding agent for dental prosthetics. Applied by dental professionals in a clinical setting to facilitate adhesion between light-curing prosthetic base materials and PMMA-based denture bases or artificial teeth. Enhances structural integrity of dental prostheses by ensuring chemical bonding between disparate resin materials.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-curing, methyl methacrylate-free resin conditioner. Designed for chemical bonding of PMMA-based dental materials. Class II device (21 CFR 872.3760).

Indications for Use

Indicated for use as a bonding agent for 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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 5 2005

Ms. Cheryl V. Zimmerman Director, Quality Operations and Compliance Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614

Re: K043295

Trade/Device Name: Versyo®.direct Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: November 17, 2004 Received: December 06, 2004

Dear Ms. Zimmerman:

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 – 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 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 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,

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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K043295 510(k) Number (if Known):

Device Name: Veryso.direct

Indications For Use:

Versyo.direct is a 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 Runne

OR

(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices

510(k) Number: K04324