LUCITONE FRS FLEXIBEL DENTAL RESIN

K992956 · Dentsply Intl. · EBI · Oct 6, 1999 · Dental

Device Facts

• Record ID: K992956
• Device Name: LUCITONE FRS FLEXIBEL DENTAL RESIN
• Applicant: Dentsply Intl.
• Product Code: EBI · Dental
• Decision Date: Oct 6, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

LUCITONE® FRS™ FLEXIBLE DENTAL RESIN is used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.

Device Story

LUCITONE® FRS™ FLEXIBLE DENTAL RESIN is an injection-moldable, flexible thermoplastic resin. It is used by dental professionals to fabricate removable dental appliances, including partial or full dentures, occlusal splints, and night guards. The device functions as a restorative material; it is processed via injection molding to form the final appliance shape. The resulting appliance provides a flexible, durable structure for patient use. Safety and effectiveness are supported by biocompatibility testing and physical property comparisons to predicate materials.

Clinical Evidence

Bench testing only. Biocompatibility evaluations included MEM Elution, Ames Mutagenicity, Mucous Membrane Irritation, Hamster Cheek Pouch Irritation, and Kligman Maximization studies (NaCl and Cottonseed oil). Results demonstrated the material is non-cytotoxic, non-mutagenic, non-irritant, and a non-sensitizer.

Technological Characteristics

Injection-moldable, flexible thermoplastic resin. Components consist of materials previously used in legally marketed dental devices. Evaluated for biocompatibility per standard dental safety protocols.

Indications for Use

Indicated for patients requiring partial or full removable dentures, occlusal splints, or night guards.

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

• Valplast® Resin Material (Pre-1976 Device)

Submission Summary (Full Text)

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K992956

## 510(k) SUMMARY

#### DENTSPLY International

570 West College Avenue P.O. Box 872 York, PA 17405-0872 NAME & ADDRESS: [phone] × 1717-854-2343

P. J. Lehn Telefax [phone]

P. Jeffery Lehn CONTACT:

August 31, 1999 DATE PREPARED:

TRADE OR PROPRIETARY NAME:

COMMON OR USUAL NAME: Denture material

Denture relining, repairing or rebasing resin CLASSIFICATION NAME: 872.3760

PREDICATE DEVICE: Valplast® Resin Material Pre-1976 Device

DEVICE DESCRIPTION: LUCITONE® FRS™ FLEXIBLE DENTAL RESIN is an injection moldable, flexible thermoplastic resin designed for fabricating removable dental appliances.

Physical property testing indicates that LUCITONE® FRS™ FLEXIBLE DENTAL RESIN performs equal to or better than the predicate device.

INTENDED USE: LUCITONE® FRS™ FLEXIBLE DENTAL RESIN is used for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in LUCITONE® FRS™ FLEXIBLE DENTAL RESIN have been used in legally marketed devices or have been found to be safe for dental use.

LUCITONE® FRS™ FLEXIBLE DENTAL RESIN was evaluated as follows:

MEM Elution Test Ames Mutagenicity Test Mucous Membrane Irritation Hamster Cheek Pouch Irritation Test, Repeated Dose Kligman Maximization Study (NaCI) Kligman Maximization Study (Cottonseed oil)

Non-cytotoxic Non-mutagenic Non-irritant Non-irritant Non-sensitizer Non-sensitizer

We believe that the similarity in composition of LUCITONE® FRS™ FLEXIBLE DENTAL RESIN to the predicate device, the performance data, and the results of biocompatibility testing support the safety and effectiveness of LUCITONE® FRS™ FLEXIBLE DENTAL RESIN for the indicated uses.

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### Substantial Equivalence Comparison:

ID of Predicate Device:

Valplast® Resin Material, manufactured and distributed by Valplast International, is the predicate device for LUCITONE® FRS™ FLEXIBLE DENTAL RESIN.

Valplast Resin Material was labeled and promoted prior to May 28, 1976. The attached literature indicates the predicate device was marketed in 1954. The FDA establishment registration information for Valplast International is also attached.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 1999 ост

Mr. P. Jeffrey Lehn Director, Corporate Compliance and Regulatory Affairs DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872

K992956 Re :

> Lucitone® FRS™ Flexibel Dental Resin Trade Name: Requlatory Class: II Product Code: EBI Dated: August 31, 1999 September 2, 1999 Received:

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 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 Regulations, Title 21, Parts 800 to 895. ਸ 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 Register. 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.

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#### Page 2 - Mr. Lehn

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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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K992956

## PREMARKET NOTIFICATION

# INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 801.109)

K9929S6

Device Name: LUCITONE® FRS™ FLEXIBLE DENTAL RESIN

Used for fabrication of partial or full removable dentures, as well as occlusal splints and night guards.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

510(K) Number:

Over-The-Counter Use __

Susan Renner

OR

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number .

000007