JELDENT MULTICRYL

K990056 · J.F. Jelenko & Co., Inc. · EBI · Mar 25, 1999 · Dental

Device Facts

• Record ID: K990056
• Device Name: JELDENT MULTICRYL
• Applicant: J.F. Jelenko & Co., Inc.
• Product Code: EBI · Dental
• Decision Date: Mar 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Multicryl is a dual technique resin for auto- and heat cure technique. It is used as multipurpose acrylic for pour- and presspack technique with one powder and two liquids: COLD for pour technique and HEAT for presspack technique. Cold curing: -upper and lower full dentures (pour technique) -completion of partial dentures -repairs Heat Cure: - upper and lower full dentures (presspack technique)

Device Story

Multicryl is a multipurpose acrylic resin system consisting of one powder and two distinct liquids (COLD for pour technique; HEAT for presspack technique). Used by dental professionals for the fabrication of full and partial dentures and for denture repairs. The device functions as a restorative dental material; it is mixed and cured by the clinician to form the denture base or repair material. It provides a dual-technique solution for dental laboratories or clinics, allowing for both auto-curing and heat-curing workflows depending on the specific clinical or laboratory requirement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dual-technique acrylic resin system; consists of one powder and two liquids (cold-cure and heat-cure formulations). Used for dental prosthetic fabrication and repair. Class II device.

Indications for Use

Indicated for fabrication of upper and lower full dentures, completion of partial dentures, and repairs using either pour (cold cure) or presspack (heat cure) techniques.

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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles three overlapping human figures or a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 1999

Mr. Raphael Judkins Ouality Systems Administrator J.F. Jelenko & Company, Incorporated 99 Business Park Drive Armonk, New York 10504

Re : K990056 JelDent™ Multicryl Trade Name: Requlatory Class: II Product Code: EBI Dated: December 31, 1998 Received: January 7, 1999

Dear Mr. Judkins:

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 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). You may, therefore, market the device, subject to the qeneral 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. ಗ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS 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. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Judkins

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 Also, please note the Office of Compliance at [phone]. the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Palitrea Cucurbitafloe

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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Image /page/2/Picture/0 description: The image shows the logo for Jelenko Dental Health Products. The logo consists of the word "JELENKO" in large, bold, black letters. Below the word "JELENKO" are the words "DENTAL HEALTH PRODUCTS" and "ISO 9001 REGISTERED" in smaller, black letters.

BUSINESS PARK DRIVE, ARMONK, NEW YORK 10504 USA http://www.jelenko.com

[phone] PHONE: [phone] FAX: [phone]

## INDICATIONS FOR USE

Page 1 of 2

**510(k) Number:** K990056

Device Name:

Multicryl is a dual technique resin for auto- and heat cure technique. It is used as multipurpose acrylic for pour- and presspack technique with one powder and two liquids: COLD for pour technique and HEAT for presspack technique.

Cold curing: -upper and lower full dentures (pour technique) -completion of partial dentures -repairs

Heat Cure: - upper and lower full dentures (presspack technique)

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CONCURRENCE OF CHRD, OFFICE OF DEVICE EVALUATION (OED)

| | Susan Plummer |
|---------------------------------------------------------------------|---------------|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K990056 |

| Prescription use ✓ (Per 21 CFR 801.109) | OR | Over-The-Counter Use ______ |
|-----------------------------------------|----|-----------------------------|
|-----------------------------------------|----|-----------------------------|