(72 days)
Not Found
Not Found
No
The summary describes prefabricated denture teeth made of methyl methacrylate, with no mention of AI or ML technology.
No
The device is described as "prefabricated devices, composed of methyl methacrylate material, which are intended for use as teeth in a denture." While dentures replace missing teeth, the teeth themselves are a component of the denture, not a therapeutic device that treats or prevents a disease.
No
Explanation: The device is described as "prefabricated devices, composed of methyl methacrylate material, which are intended for use as teeth in a denture." There is no indication that it is used for diagnosing any condition.
No
The device description explicitly states it is composed of "methyl methacrylate material," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use as teeth in a denture." This describes a physical component used in a medical device (a denture) that is placed in the body.
- Device Description: The description is of a "prefabricated device, composed of methyl methacrylate material." This is a material and a physical object.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or treatment.
- Any kind of testing or diagnostic procedure.
IVDs are used to perform tests on samples taken from the body to provide diagnostic information. This device is a physical component of a prosthetic.
N/A
Intended Use / Indications for Use
ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V and Z-TONE Preformed Plastic Denture Teeth are prefabricated devices, composed of methyl methacrylate material, which are intended for use as teeth in a denture.
Product codes (comma separated list FDA assigned to the subject device)
ELM
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 872.3590 Preformed plastic denture tooth.
(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2002
Dental Manufacturing S.P.A C/O Mr. Kevin Walls Consultant Regulatory Insight Incorporated 13 Red Fox Lane Littleton, Colorado 80127
Re: K013824
Trade/Device Name: Acry Plus, Acry Lux, Acry Lux V, Acry Rock, Acry Rock V, and Z-Tone Preformed Plastic Denture Teeth Regulation Number: 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: ELM Dated: November 16, 2001 Received: November 19, 2001
Dear Mr. Walls:
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
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 modified in any Federal statutes and regulations administered by other Federal agencies. or the ret of any - with all the Act's requirements, including, but not limited to: registration r od intiles contrily ware 807); labeling (21 CFR Part 801); good manufacturing practice and ifsing (21 CF Part 827), and 1017, and (QS) regulation (21 CFR Part 820); and if requirements as bet form 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 110(k) premarket notification. The FDA finding of substantial equivalence of your device to s logic premiered 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 n you detime ally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/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
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510(k) Number (if known): K013824
ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY Device Name: ROCK V and Z-TONE Preformed Plastic Denture Teeth
Indications for Use: ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V and Z-TONE Preformed Plastic Denture Teeth are prefabricated devices, composed of methyl methacrylate material, which are intended for use as teeth in a denture.
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Pena
(Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________
Prescription Use × (Per 21 CFR 801.109)