(86 days)
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No
The summary describes a cold-curing and heat-curing methyl methacrylate resin for dental applications, with no mention of AI or ML technology.
No.
The device is a cold-curing or heat-curing methyl methacrylate resin for dental prosthetics (dentures, repairs, additions), not for treating a disease or condition.
No
The "Intended Use / Indications for Use" section describes the device as various types of methyl methacrylate resins used for fabricating, repairing, and relining dentures. This indicates a therapeutic or restorative purpose rather than a diagnostic one.
No
The 510(k) summary describes a methyl methacrylate resin, which is a physical material used in dentistry, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are all related to the fabrication, repair, and modification of dentures and denture bases. These are procedures performed outside of the body, on materials that will be placed in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples from the human body (like blood, urine, tissue, etc.) to provide information about a person's health, disease state, or condition.
IVDs are specifically designed to be used in vitro (in glass, or outside the body) to examine specimens from the human body. This device is used to create and modify dental prosthetics, which is a different category of medical device.
N/A
Intended Use / Indications for Use
Cold-curing, methyl methacrylate resin for adding the saddles to cobalt chrome denture bases, repairs, additions and relines, and relines. Cold-curing, methyl methacrylate resin for the completion of full and partial dentures. Cold-curing, methyl methacrylate resin for adding saddles to cobalt chrome dentures bases, repairs, additions for injection moulding techniques (e. g. Unipress). Cold-curing, methyl methacrylate resin intended specifically. Cold-curing repair resin for additions, replacing teeth and other repairs. Heat-curing, methyl methacrylate resin for fabricating partial and full dentures using flasks and clamps or injection moulding systems. Heat-curing, methyl methacrylate resin, with liquid phase, for adding the saddles to cobalt chrome denture bases and relining dentures.
Product codes
EBI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/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 an abstract image of what appears to be an eagle.
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.
1
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
2
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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the