VITRON H

K991220 · Espe Dental AG · EBI · May 20, 1999 · Dental

Device Facts

• Record ID: K991220
• Device Name: VITRON H
• Applicant: Espe Dental AG
• Product Code: EBI · Dental
• Decision Date: May 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

Fabrication of full and partial dentures

Device Story

VITRON® H is a pourable, heat-cured methylmethacrylate-based resin used for the fabrication of complete or partial removable dentures and other removable dental appliances. The device utilizes a barbituric acid-catalyzed polymerization process. It is intended for professional use by dental clinicians in a laboratory or clinical setting. The material is processed via a plugging-pressing procedure within a flask. By providing a stable, biocompatible denture base material, the device enables the creation of functional dental prosthetics to restore patient oral function and aesthetics.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by the long clinical history and established use of the underlying methylmethacrylate and barbituric acid-catalyzed technology in predicate devices.

Technological Characteristics

Methylmethacrylate-based denture base resin; heat-cured; barbituric acid-catalyzed polymerization system; pourable consistency; intended for flask polymerization via plugging-pressing procedure.

Indications for Use

Indicated for the fabrication of full and partial dentures in patients requiring removable dental appliances.

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.

Predicate Devices

• PALADON® 65 by Kulzer (K901789)
• PALAPRESS® VARIO by Kulzer
• LIQCRYLIC® by Dentsply (K972573)

Reference Devices

• SELECTA-PLUS®
• TREVAPRESS®

Submission Summary (Full Text)

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MAY 20 199

#### II. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

#### Submitter

| Name: | ESPE Dental AG |
|------------------------------------|-------------------------------------------|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number: | 9611385 |
| Contact: | Dr. Andreas Petermann, Regulatory Affairs |
| Phone: | 011-49-8152-7001395 |
| Fax: | 011-49-8152-7001869 |
| E-mail | Andreas_Petermann @ESPE.de |
| Date: | April 9, 1999 |

## Name of Device

| Proprietary Name: | VITRON ® H |
|----------------------|------------------------------------------------|
| Classification Name: | Denture relining, repairing, or rebasing resin |
| Common Name: | Denture base material |

## Predicate Devices

| PALADON® 65 by Kulzer | |
|----------------------------------|--|
| PALAPRESS® VARIO by Kulzer | |
| LIQCRYLIC® by Dentsply K 972573 | |

Description for the Premarket Notification

VITRON® H is classified as a denture relining, repairing, or rebasing resin (21 C.F.R. § 872.3760) because it is a device composed of methylmethacrylate intended to be used in the fabrication of complete or partial removable dentures and other removable dental appliances.

VITRON® H is a pourable, heat cured material for the production of dentures according to the plugging-pressing procedure of flask polymerization. It is thus similar and substantially equivalent in intended use and function to Kulzer's denture relining, repairing, or rebasing resin PALADON® 65 (K 901789).

Image /page/0/Picture/12 description: The image shows the text "510(k) VITRON® H" above the word "ESPE". To the left of the word ESPE is a logo of a tree inside of a square. The text and logo are all in black and white.

Page 2 of 47

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Though the composition of PALADON® 65 is not available it is known that it consists of the same common monomer system. Kulzer's PALAPRESS® VARIO and Dentsply's LIQCRYLIC® PRO DENTAL RESIN do also comprise similar monomers and use the same well-known barbituric acid catalyzed starting mechanism as Vitron® H.

Kulzer's PALADON® 65. PALAPRESS® VARIO and Dentsply's LIQCRYLIC® PRO DENTAL RESIN are well established and determined to be safe and effective devices.

PALAPRESS® VARIO is marketed in the United States since 1992. Dentsply has marketed the same device as SELECTA-PLUS® and TREVAPRESS® in Europe and South America for over 25 years. The technology of methyl methacrylate based denture base materials which are cured by a barbituric acid based catalyst system is over 30 years old and has a long clinical history. In our opinion biocompatibility studies are therefore not necessary to prove the safety and efficacy of VITRON® H's formulation.

In our opinion the substantial equivalence of VITRON® H to the predicate devices PALADON® 65, PALAPRESS® VARIO and LIQCRYLIC® PRO DENTAL RESIN with long marketing history and clinical experience, and the performance data support the safety and effectiveness of VITRON® H for the intended use.

Image /page/1/Picture/4 description: The image shows the text "510(k) VITRON H" on the top line. Below that is a logo of a leaf inside of a square. To the right of the logo is the text "ESPE" in large, bold letters. The image appears to be a product label or logo.

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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol. The logo is presented in black and white.

MAY 20 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Andreas Petermann Regulatory Affairs ESPE Dental AG ESPE Platz D-82229 Seefeld Bavaria, Germany

Re : K991220 Trade Name: Vitron®H Requlatory Class: II Product Code: EBI Dated: April 9, 1999 Received: April 12, 1999

Dear Dr. Petermann:

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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labelinq, 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Petermann

this response to your premarket notification Please note: submission does not affect any obligation you miqht have under sections 531 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 market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone]
or at its internet address "http://www.fda.gov/cdrh/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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K991220

# STATEMENT OF INDICATIONS FOR USE

Device Name:

Vitron® H

Indications for use:

Fabrication of full and partial dentures

Prescription use: 网

Over-the counter use □

Susan Runnr

(Division Sign-C Division of Dental, Int and General Hospital 510(k) Number