VITRON M

K990763 · Espe Dental AG · EBI · May 25, 1999 · Dental

Device Facts

• Record ID: K990763
• Device Name: VITRON M
• Applicant: Espe Dental AG
• Product Code: EBI · Dental
• Decision Date: May 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

Denture base material for: Completion of metal frameworks Partial and total denture rebasing Extension of partial dentures Repairs Fabrication of partial and total dentures

Device Story

VITRON M is a pourable, cold-cured methylmethacrylate-based denture base material. It is used by dental professionals in a clinical or laboratory setting for the fabrication, repair, rebasing, and extension of removable dental appliances, including complete and partial dentures and metal frameworks. The material utilizes a barbituric acid-based initiator system for curing. By providing a stable, moldable resin that hardens to form the denture base, the device enables the restoration of dental function and aesthetics for patients requiring prosthetic support. The device is applied manually by the clinician or technician during the dental appliance construction or repair process.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by the established clinical history of the methylmethacrylate and barbituric acid-based catalyst technology used in the predicate devices.

Technological Characteristics

Methylmethacrylate-based resin; cold-cured; barbituric acid-based initiator system; pourable consistency. No specific ASTM standards or connectivity features described.

Indications for Use

Indicated for patients requiring fabrication, repair, rebasing, or extension of complete or partial removable dentures and other 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

• PALAPRESS® VARIO (K 902115)
• LIQCRYLIC® (K 972573)

Submission Summary (Full Text)

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# K990762

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

### 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 | [e-mail] |
| Date: | March 3, 1999 |

#### Name of Device

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

#### Predicate Devices

| PALAPRESS® VARIO by Kulzer | K 902115 |
|----------------------------|----------|
| LIQCRYLIC® by Dentsply | K 972573 |

### Description for the Premarket Notification

VITRON® M 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, repair, rebasing of complete or partial removable dentures and other removal dental appliances.

VITRON® M is a pourable, cold cured denture base material and, thus similar and substantially equivalent in intended use and function to Kulzer's denture relining, repairing, or rebasing resin PALAPRESS® VARIO (K 902115) and Dentsply's LIQCRYLIC® PRO DENTAL RESIN (K 972573). Though the exact composition of PALAPRESS® VARIO and LIQCRYLIC® is not available, it is known that they consist of

Image /page/0/Picture/12 description: The image shows the text "510(k) VITRON® M ESPE". The text is arranged in three lines, with "510(k) VITRON® M" on the top line and "ESPE" on the bottom line. There is a logo to the left of the text.

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the same monomers and prepolymerized oligomers and are cured by the same well-known barbituric acid based initiator system as VITRON® M.

Kulzer's denture base material PALAPRESS® VARIO and Dentsply's LIQCRYLIC® PRO DENTAL RESIN are well established and determined to be safe and effective.

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® M's formulation.

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

Image /page/1/Picture/4 description: The image shows the text "510(k) VITRON M" on the top line. Below that is a logo of a tree inside of a square. To the right of the logo is the word "ESPE" in large, bold letters. The image is in black and white.

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Image /page/2/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 a stylized image of an eagle with three lines representing its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 1999

Dr. Andreas Petermann Requlatory Affairs ESPE DENTAL AG ESPE Platz D-82229 Seefeld Bavaria, Germany

Re : K990763 Vitron® M Trade Name: Regulatory Class: II Product Code: EBI March 3, 1999 Dated: Received: March 8, 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, labeling, 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 requlations 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) requlation (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 Reqister.

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Page 2 - Dr. Petermann

Please note: this response to your premarket notification submission does not affect any obligation you might 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,

Patricia Cucurullo

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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## STATEMENT OF INDICATIONS FOR USE

Device Name:

VITRON® M

Indications for use:

Denture base material for: Completion of metal frameworks Partial and total denture rebasing Extension of partial dentures Repairs Fabrication of partial and total dentures

Prescription use: 区

Over-the counter use □

Susan Kunz

(Division Si Division of Dental, Infection Control, and General Hospi r ´´´/k) Number