LIQCRYLIC PRO DENTAL RESIN

K972573 · Dentsply Intl. · EBI · Sep 16, 1997 · Dental

Device Facts

• Record ID: K972573
• Device Name: LIQCRYLIC PRO DENTAL RESIN
• Applicant: Dentsply Intl.
• Product Code: EBI · Dental
• Decision Date: Sep 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

LIQCRYLIC™ PRO DENTAL RESIN is used in the fabrication, repair or rebasing of complete or partial removable dentures and other removable dental appliances.

Device Story

LIQCRYLIC™ PRO DENTAL RESIN is a pourable, cold-curing powder and liquid polymethyl methacrylate (PMMA) denture base material. It utilizes a barbituric acid-based catalyst system, replacing conventional benzoyl peroxide/amine systems to improve color stability. The device is intended for use by dental professionals in the fabrication, repair, or rebasing of removable dentures and dental appliances. It offers faster mixing, shorter cure cycles, and easier finishing compared to conventional pour resins. The device is marketed in standard denture base shades.

Clinical Evidence

No clinical data provided. The manufacturer relies on the long clinical history of the underlying technology (over 30 years) and substantial equivalence to a predicate device to support safety and efficacy.

Technological Characteristics

Pourable, cold-curing powder and liquid polymethyl methacrylate (PMMA) denture base material. Utilizes a barbituric acid-based catalyst system. Marketed in Lucitone® 199 shades.

Indications for Use

Indicated for the fabrication, repair, or rebasing 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 Resin (K902115)

Submission Summary (Full Text)

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## 510(k) SUMMARY

Image /page/0/Picture/21 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and are closely spaced together. The word appears to be a logo or brand name. The font is a solid black color, and the background is white.

NAME & ADDRESS:

DENTSPLY International

570 West College Avenue P.O. Box 872 York, PA 17405-0872 [phone]

SEP 1 6 1997

K972573

P. J. Lehn Telefax [phone]

CONTACT: P. Jeffery Lehn

DATE PREPARED: July 9, 1997

TRADE OR PROPRIETARY NAME: LIQCRYLIC™ PRO DENTAL RESIN

Denture relining, repairing or rebasing resin 872.3760 CLASSIFICATION NAME:

K902115 PREDICATE DEVICE: Palapress Vario Resin

DEVICE DESCRIPTION: LIQCRYLIC™ PRO DENTAL RESIN is a pourable, cold-curing powder and liquid polymethyl methacrylate denture base material. It is color stable due to the fact that it utilizes a barbituric acid based catalyst system in lieu of the conventional benzoyl peroxide/amine catalyst system. It will be marketed in the popular Lucitone® 199 denture base shades. LIQCRYLIC™ PRO DENTAL RESIN mixes more quickly, has a shorter cure cycle and can be finished easier than the conventional pour resins currently available in the U.S. market.

INTENDED USE: LIQCRYLIC™ PRO DENTAL RESIN is used in the fabrication, repair or rebasing of complete or partial removable dentures and other removal dental appliances.

TECHNOLOGICAL CHARACTERISTICS: LIQCRYLIC™ PRO DENTAL RESIN is substantially equivalent to Palapress Vario (K902115) by Kulzer.

Kulzer has marketed the predicate device, Palapress Vario, in the United States since 1992 (K902115), and DENTSPLY has marketed this device (as Selecta-plus® Material and Trevapress® Material) in Europe and South America for over 25 years. The technology is over 30 years old and has a long clinical history. Therefore, we believe that biocompatibility studies are not necessary to prove the safety and efficacy of this formulation.

We believe that the substantial equivalence of LIQCRYLIC™ PRO DENTAL RESIN to the predicate device (K902115) marketed in the U.S., the long market history of the device of the U.S., and the performance data support the safety and effectiveness of LIQCRYLIC™ PRO DENTAL RESIN for the intended use.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of a bird-like figure composed of three human profiles facing right, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 1 6 1907

Mr. P. Jeffrey Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue York, Pennsylvania 17405

Re: K972573 Trade Name: Liqcrylic™ Pro Dental Resin Requlatory Class: II Product Code: EBI Dated: July 9, 1997 Received: July 10, 1997

Dear Mr. Lehn:

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 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 (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. ਬ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq 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. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Lehn

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 requlations.

Please also be advised that FDA is examining whether the Modified Human Draize Test, as it is currently conducted on medical gloves, is a valid means of predicting the sensitization potential of latex or synthetic materials. I E FDA finds that the test is not a scientifically sound means to predict latex or synthetic materials hypersensitivity reactions in users, then hypoallergenic claims included in labeling for medical gloves may be considered misleading, and we will move to have the claim removed from labeling for all medical gloves.

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 regulation (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 gener 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,

Patrici Cucureatz /for

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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## PREMARKET NOTIFICATION

## INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 801.109)

510(K) Number:

1972573

Device Name:

LIQCRYLIC™ PRO DENTAL RESIN

Indications for Use:

Used in the fabrication, repair or rebasing of complete or partial

removable dentures and other removable dental appliances.

Susan Rump

rence of CDRH, Office of Device Evaluation (ODE) Divisio and Gene 510(k) Numb Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR Prescription

000007