FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000

K052073 · Schutz-Dental GmbH · EBI · Oct 26, 2005 · Dental

Device Facts

• Record ID: K052073
• Device Name: FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000
• Applicant: Schutz-Dental GmbH
• Product Code: EBI · Dental
• Decision Date: Oct 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

Cold-curing, methyl methacrylate resin for adding the saddles to cobalt chrome denture bases, repairs, additions and relines. FuturaPress N: Cold-curing, methyl methacrylate resin for the completion of full and partial dentures. FuturaJet: Cold-curing, methyl methacrylate resin intended specifically for injection moulding techniques (e. g. Unipress). FuturaSelf: Cold-curing repair resin for additions, replacing teeth and other repairs. FuturAcryl 2000: Heat-curing, methyl methacrylate resin for fabricating partial and full dentures using flasks and clamps or injection moulding systems. FuluraPress HP: Heat-curing, methyl methacrylate resin, with liquid phase, for adding the saddles to cobalt chrome denture bases and relining dentures.

Device Story

Device consists of a line of methyl methacrylate resins (cold-curing and heat-curing) used by dental technicians in laboratory settings. Products include FuturaPress LT, N, and HP; FuturaJet; FuturaSelf; and FuturAcryl 2000. Resins are applied to denture bases or used for full/partial denture fabrication via flask/clamp or injection molding techniques. These materials facilitate structural modifications to dental prosthetics, such as relining, repairing, or adding components to cobalt chrome bases. Final output is a cured, rigid dental appliance component. Benefits include restoration of denture fit, structural integrity, and aesthetic function for patients requiring prosthetic dental care.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Methyl methacrylate resin-based dental materials. Available in cold-curing and heat-curing formulations. Designed for manual application or injection molding techniques. Class II device under 21 CFR 872.3760.

Indications for Use

Indicated for dental laboratory use in the fabrication, repair, relining, or rebasing of full and partial dentures, including addition of saddles to cobalt chrome denture bases and tooth replacement.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 2005

Mr. Michael Wierz Export Sales Manager Schutz-Dental GMBH Dieselstrasse 5-6 Rosbach, Hessen GERMANY D-61191

Re: K052073

Trade/Device Name: FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTRAGEN Regulation Number: 21 CFR 872.3760 Regulation Name: Denture relining, repairing, or rebasing resin Regulatory Class: II Product Code: EBI Dated: July 28, 2005 Received: August 1, 2005

Dear Mr. Wierz:

This letter corrects our substantially equivalent letter of October 26, 2005

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Wierz

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Ruane

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

| 510(k) Number (if known): | |
|---------------------------|--|
| Device Name: | |
| Indications for Use: | |

Cold-curing, methyl methacrylate resin for adding FuturaPress LT the saddles to cobalt chrome denture bases, repairs, additions and relines,

and relines.

other repairs.

moulding systems.

FuturaPress N

FuturaJet

FuturaSelf

FuturAcryl 2000

FuluraPress HP

FuturaGen

relining dentures. Cold-curing, methyl methacrylate resin for the completion of full and partial dentures.

Cold-curing, methyl methacrylate resin for adding

for injection moulding techniques (e. g. Unipress).

saddles to cobalt chrome dentures bases, repairs, additions

Cold-curing, methyl methacrylate resin intended specifically

Cold-curing repair resin for additions, replacing teeth and

Heat-curing, methyl methacrylate resin for fabricating partial and full dentures using flasks and clamps or injection

Heat-curing, methyl methacrylate resin, with liquid phase, for adding the saddles to cobalt chrome denture bases and

Prescription Use
(Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

Sin Sinn-Off) Micron of Anesthes intripy. General Hospital, Interion Control, Demal Devices

Number: 16052073

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