(167 days)
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No
The summary describes acrylic teeth for dentures, with no mention of AI, ML, or any related technologies.
No
The device, artificial acrylic teeth, replaces missing teeth but does not treat a disease or condition; it is a prosthetic device.
No
Explanation: The device, Acrylic Teeth, is used for making full and partial dentures and is fitted into a patient's mouth as a removable appliance. Its description and intended use do not suggest it is used for diagnosis or detecting medical conditions.
No
The device description clearly states "Artificial Teeth (Acrylic Teeth)" and describes their use in making dentures, which are physical objects. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for making dentures, which are prosthetic devices fitted into a patient's mouth. This is a mechanical and structural application, not a diagnostic one.
- Device Description: The device is described as "Artificial Teeth (Acrylic Teeth)". This further reinforces its role as a physical component for a dental appliance.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
IVD devices are specifically designed to perform tests on biological samples to diagnose diseases, monitor health, or determine treatment options. This device does not fit that description.
N/A
Intended Use / Indications for Use
ACRYLIC TEEHT ARE USE FOR MAKING, FULL AND PARTIAL DENTURES. THE ACRYLIC TEEHT ARE MOUNTED ON A APPLIANCE,MADE OF DENTAL ACRYLIC. ONCE THAT APPLIANCE IS MADE IS FITTED IN TO PATIENT MOUTH THIS APPLIANCE IS REMOVABLE ,IS NOT IMPLANTED.
Product codes
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines beneath them. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 7 2000
Mr. Juan Fernando Salazar MasterDent, Ltda. CRA. No. 39 Sur 90 A.A. 52101 Medellin Envigado, Columbia
Re : K992854 Artificial Teeth (Acrylic Teeth) Trade Name: Requlatory Class: II Product Code: ELM Dated: November 17, 1999 Received: November 30, 1999
Dear Mr. Salazar:
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 qeneral controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst 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 Regulations, Title 21, Parts 800 to 895. A 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 requlation 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
1
Page 2 - Mr. Salazar
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.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (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 (800) 638-2041 or (301) 443-6597 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
2
K94 2854/A1
Page
STO(K) NUMBER (IF KNOWN) :
ARTIFICIAL TEEHT(Acrylic_Teeht) DEVICE NAME : INDICATIONS FOR USE:
ACRYLIC TEEHT ARE USE FOR MAKING, FULL AND PARTIAL DENTURES. THE ACRYLIC TEEHT ARE MOUNTED ON A APPLIANCE,MADE OF DENTAL ACRYLIC. ONCE THAT APPLIANCE IS MADE IS FITTED IN TO PATIENT MOUTH THIS APPLIANCE IS REMOVABLE ,IS NOT IMPLANTED.
SINCERELY.
Juan Fernando Salazar .
(PLEASE DO MOT WRITE BELOW THIS TIME-CONTINUE ON ANO. IF NEEDED I
Suzakunna
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. 10992854
Concurrence of CDRH, Office of Device Evaluation
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Co
(Optional
FDA/OTPO/ODE/DHO
15 10
SK67
Image /page/2/Picture/11 description: The image is a black and white photograph. The image is mostly white with some black spots scattered throughout. The black spots are small and irregular in shape.