(157 days)
These dental plastic teeth are parts used for denture fabrication. PMMA is mixed with monomer in a polymenzation process. The plastic teeth are part of dentures made to fit a patient's mouth which are removable or may be attached to dental implant devices.
The synthetic plastic teeth are used in the production of dentures. They are produced from a I he synuletic process. Polymethylmethacrylate or PMMA is mixed with methylmethacrylate monomer, a cross linking agent and non-toxic pigments under heat and pressure. Once the monomer, a cross iniking agoit and non teen are checked for flash and polished according to the relevant model characteristics.
The provided text is a 510(k) summary for "Denture Preformed Plastic Teeth Proprietary Models: Dentavit, Monarch, Acrotone, Senator, Dentorium". This document is a premarket notification to the FDA for medical devices.
Crucially, this document describes a device that is a physical product (plastic teeth for dentures), not an AI/ML powered device, a diagnostic device, or a software device that would require performance criteria in the way your request outlines.
Therefore, the requested information about acceptance criteria, study details, sample sizes, experts, MRMC studies, standalone performance, and ground truth types is not applicable to this document.
The 510(k) summary focuses on demonstrating Substantial Equivalence to legally marketed predicate devices, meaning it argues that the new device is as safe and effective as existing, approved devices.
Here's a breakdown of what the document does provide, related to its safety and effectiveness, in the context of substantial equivalence:
1. Acceptance Criteria and Reported Device Performance (as applied to Substantial Equivalence):
Instead of performance metrics like sensitivity, specificity, or AUC for an AI device, this document demonstrates equivalence through material composition, manufacturing process, and adherence to established standards.
| Acceptance Criterion | Reported Device Conformance/Evidence |
|---|---|
| Chemical Composition (material) | "The plastic teeth have comparable chemical composition as the predicate devices." (Utilizes Polymethylmethacrylate or PMMA, methylmethacrylate monomer, cross-linking agent, non-toxic pigments.) |
| Physical Characteristics (size, shape, color) | "The models are similar in size, shape, color, and usage to the predicate devices." |
| Manufacturing Process | "The added models use the same materials and controls established for over 20 years." and "PMMA is mixed with monomer in a polymerization process." |
| Intended Use | "The intended use for these plastic teeth is to make partial or full dentures." (Matches predicate devices). "These dentures are made to fit the patient's mouth as a removable device, not implanted. These plastic tech may also be attached to dental implants." |
| Conformity to Standards | - CE Medical Directive 93/42/EEC 2007/47/EC- ISO9001/GMP/ISO13485: Quality System Certification- ADA specification No. 15:2008 Artificial Teeth- BS EN ISO22112:2006- Biocompatibility Standards ISO10993-1, ISO7405:2008 |
| Lack of New Safety/Effectiveness Questions | "This control activity shows that there are no new questions of safety and effectiveness for the plastic teeth models made by Wright." "The minor differences raise no new issues of safety or effectiveness." |
| Company History/Experience | "Wright has been a manufacturer for about 100 years and has been in the market for over 40 years and has met preamendment rules. There are no significant health incidents in that time." |
The following points cannot be answered from the provided text as they relate to AI/ML or diagnostic device studies, which is not what this document describes:
- Sample sizes used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML algorithm evaluation. The "testing" referred to is physical materials reliability and safety testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth in the AI/ML sense.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical product, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. There is no AI/ML model with a training set.
- How the ground truth for the training set was established: Not applicable.
In summary: This 510(k) pertains to denture teeth, a traditional medical device, not a software or AI-powered one. Therefore, the typical performance criteria and study design elements for AI/ML devices or diagnostics as requested are not present in this submission. The "study" proving acceptance criteria is a compilation of material testing, adherence to manufacturing quality standards, and comparison to predicate devices, all aimed at demonstrating substantial equivalence.
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510(K) SUMMARY August 10, 2012
SUBMITTER INFORMATION: (3003103749)
Wright Health Group Ltd. Dunsinane Industrial Estate Kingsway West Dundee, Scotland DD2 3QD UK
FDA AGENT/CORRESPONDING OFFICIAL INFORMATION:
North American Technical Services (NATS) Corp. 30 Northport Rd Sound Beach, NY 11789 Tel: 631-744-0059 Fax: 631-744-0192 Email: natscorp@aol.com Contact: Stephen T. Micoch
DEVICE NAME:
Name: Denture Preformed Plastic Teeth Proprietary Models: Dentavit, Monarch, Acrotone, Senator, Dentorium Classification: II Product Code: ELM Regulation: 21 CFR 872.3590
PREDICATE DEVICES:
Union Dental S.A./ Unidesa Odi K070591 - model Replica Dental Vipi Ltd K022300 - model Vipi Dent Plus Vident K914476 - model Vitapan Huge Dental Material Co., Ltd. K101029 -- model Kaili
DESCRIPTION:
The synthetic plastic teeth are used in the production of dentures. They are produced from a I he synuletic process. Polymethylmethacrylate or PMMA is mixed with methylmethacrylate monomer, a cross linking agent and non-toxic pigments under heat and pressure. Once the monomer, a cross iniking agoit and non teen are checked for flash and polished according to the relevant model characteristics.
SUBSTANCIAL EQUIVALENCE AND TECHNOLOGY:
The plastic teeth have comparable chemical composition as the predicate devices. The models I he piastic tecur have comparable chesage to the predicate devices. Also, preamendment are similal in size, shape, color, and asage to the productive. The added models use the same materials and controls established for over 20 years.
MAR 0 1 2013
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The intended use for these plastic teeth is to make partial or full dentures. These dentures are made to fit the patient's mouth as a removable device, not implanted. These plastic tech may also be attached to dental implants.
Federal law restricts this device to sale by or on the order of a physician. It is intended to be used only by appropriately trained and qualified healthcare professionals and servicing staff in clinical environments.
SUMMARY OF NONCLINICAL TESTS AND DESIGN CONTROL ACTIVITIES:
The performance and safety testing activities were conducted on acceptable dental materials to establish the reliability characteristics of these teeth devices. Validation and verification of compliance with the following mandatory and voluntary standards has been made
- CE Medical Directive 93/42/EEC 2007/47/EC t
- ISO9001/GMP/ISO13485: Quality System Certification . Factory control procedures are established for production QA and QC with use of ADA specification No. 15:2008 Artificial Teeth, and BS EN ISO22112:2006, with Biocompatibility Standards ISO10993-1, ISO7405:2008
This control activity shows that there are no new questions of safety and effectiveness for the plastic teeth models made by Wright.
CONCLUSION:
For and and the transity
The plastic teeth are substantially equivalent to the predicate teeth and have the same intended use. They are suitable for equivalent use on dentures according to the specifications stated based on the same materials, production process and technology.
Wright has been a manufacturer for about 100 years and has been in the market for over 40 years and has met preamendment rules. There are no significant health incidents in that time. These models have the same intended use and similar indications, technical characteristics and function as the predicate devices. Suitable dental industry materials have been used by Wight and predicate companies that solve biocompatibility, durability and esthetic concerns. The minor differences raise no new issues of safety or effectiveness. These models are substantially equivalent to the predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the staff and two snakes intertwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 1, 2013
Wright Health Group, Limited C/O Mr. Stephen Mlcoch Chief Executive Officer North American Technical Services (NATS) Corporation 30 Northport Road Sound Beach NY 11764
Re: K122955
Trade/Device Name: Plastic Teeth Models Dentavit, Monarch, Acrotone, Senator, and Dentorium Regulation Number: 21 CFR 872.3590 Regulation Name: Prosthetic Devices Regulatory Class: II Product Code: ELM Dated: January 15, 2013 Received: February 13, 2013
Dear Mr. Mlcoch:
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.
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Page 2 - Mr. Mlcoch
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 (QS) 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.htm.
Sincerely vours.
Kwame O. Ulmer for
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):
Device Name:
Plastic teeth models Dentavit, Monarch, Acrotone, Senator, and Dentorium.
Indications for Use:
These dental plastic teeth are parts used for denture fabrication. PMMA is mixed with monomer in a polymenzation process. The plastic teeth are part of dentures made to fit a patient's mouth which are removable or may be attached to dental implant devices.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S. Runner -S 2013.02.27 15:20:12 -05'00'
(Division Sign-Off) . Division of Anesthesiology, General Hospital ntection Control, Dental Devices
510(k) Number: K1208955
Page 1 of 1
§ 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.