(141 days)
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.
The New Stetic Acrylic Teeth are made of acrylic resin; the teeth come in various shades and sizes to fit the requirements of the specific patient.
The provided text details the 510(k) summary for the New Stetic Artificial Teeth, which is a preformed plastic denture tooth. The submission asserts substantial equivalence to a predicate device (King Dental Corp - King-Hue, Royal Coral, Super-C Artificial Teeth, K931162).
Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Device Performance
The device, New Stetic Artificial Teeth, is a Class II device (Preformed Plastic Denture Tooth) with product code ELM. The performance testing was conducted according to ISO 22112 First edition 2005-11-01, Dentistry -- Artificial teeth for dental prostheses.
The text does not explicitly list specific numerical acceptance criteria (e.g., minimum flexural strength, maximum water absorption) or reported device performance values in a table format. Instead, it states that "Performance testing was completed to ISO 22112 First edition 2005-11-01." This implies that the device met all the requirements outlined in this international standard for artificial dental prostheses.
Without specific performance values from the standard or the study, a "reported device performance" column cannot be fully populated with numerical data. However, based on the FDA's clearance, it is understood that the device did meet all applicable criteria within ISO 22112.
| Acceptance Criterion (from ISO 22112) | Reported Device Performance (Implied by FDA Clearance) |
|---|---|
| (Specific physical, mechanical, and chemical properties as defined by ISO 22112)* | Met all specified requirements of ISO 22112 |
*Note: The 510(k) summary does not reproduce the detailed specifications of ISO 22112. These would typically include tests for properties like bond strength, color stability, water sorption, solubility, hardness, and mechanical strength relevant to dental prostheses.
Study Information
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Sample sizes used for the test set and the data provenance:
The document does not specify the sample size used for the test set during performance testing. It also does not mention the country of origin of the data or whether the study was retrospective or prospective. The testing was conducted to an international standard (ISO 22112), which dictates testing methodologies but not necessarily data provenance in this context. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the 510(k) summary. Given that the testing was based on a laboratory standard (ISO 22112) for physical and material properties, the "ground truth" would be established through calibrated laboratory instruments and adherence to testing protocols, rather than expert human interpretation. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable or provided. Laboratory-based performance testing following an ISO standard typically relies on objective measurements rather than human adjudication of results in the way clinical studies might. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study was done. This device is a preformed plastic denture tooth, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant. The assessment focuses on the material and physical properties of the teeth. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a physical product (artificial teeth), not an algorithm or software. Its performance is inherent in its material properties and manufacturing. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for this type of device is established by objective measurements of material properties and performance characteristics defined by the international standard ISO 22112. This standard specifies tests for things like flexural strength, water absorption, color stability, and bond strength as relevant to artificial teeth. There is no "pathology" or "outcomes data" in the clinical sense for this type of premarket submission, as it relates to the physical product itself. -
The sample size for the training set:
Not applicable. This device is a physical product, not a machine learning algorithm, so there is no "training set." -
How the ground truth for the training set was established:
Not applicable. As there is no training set for a physical product, this question is not relevant.
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510(k) SUMMARY (as required by 807.92(c))
New Stetic
Regulatory Correspondent:
AJW Technology Consultants, Inc 445 Apollo Beach Blvd Apollo Beach, FL 33572 John O'Brien jobrien@ajwtech.com 813-645-2855 813-645-2856
Submitter of 510(k):
Date of Summary:
Trade/Proprietary Name:
Classification Name:
Product Code:
Intended Use:
Device Description:
Predicate Device:
September 11, 2012
Carrera 33, No 50-09
Andres Arango Velez Arango@newstetic.com Tel: + 57 4 350 47 00
Guarne, Antioquia, Colombia
New Stetic Artificial Teeth
Denture, Plastic, Teeth
ELM
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.
The New Stetic Acrylic Teeth are made of acrylic resin; the teeth come in various shades and sizes to fit the requirements of the specific patient.
K931162 - King Dental Corp - King-Hue, Royal Coral, Super-C Artifical Teeth
FEB 1 2 2013
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Technological Characteristics and Substantial Equivalence:
New Stetic claims the proposed devices to be substantially equivalent to the devices previously cleared by FDA in K931162. New Stetic claims this equivalence because the proposed devices have an equivalent intended use, manufacturing materials, operating principles and physical operational specifications as compared to the predicate devices.
There are no differences between the New Stetic Artificial Teeth K122925 and the King Dental Artificial Teeth K931162 with respect to indications for use or technology.
Performance Testing:
Performance testing was completed to ISO 22112 First edition 2005-11-01, Dentistry -- Artificial teeth for dental prostheses. (Dental/ENT).
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
February 12, 2013
New Stetic C/O Mr. John O'Brien Regulatory and Quality Systems Lead AJW Technology Consultants, Incorporated 445 Apollo Beach Boulevard APOLLO BEACH FL 33572
Re: K122925
Trade/Device Name: New Stetic Artificial Teeth Regulation Number: 21 CFR 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: ELM Dated: January 10, 2013 Received: January 25, 2013
Dear Mr. O'Brien:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.hum.
Sincerely yours,
Kwame O. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, 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): K122925
Device Name: New Stetic Artificial Teeth
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
1 of 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
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| Susan Runner DDS, MA | 08:22:07 |
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(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K122925 |
|---|---|
| ---------------- | --------- |
§ 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.