(125 days)
It is intended for use as a tooth in a denture.
These teeth are used for making full or partial dentures. The artificial resin teeth are mounted on an appliance made of dental acrylic resin. The appliance is made to fit the patient's mouth and is a removable. It is not implanted.
The Synthetic Polymer Teeth (Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, MAIST and Kaitong/Royal) used in the production of dentures are produced through a dough molding process. Polymethylmethacrylate (PMMA) is mixed with methylmethacrylate monomer and a crosslinking agent.
Once the polymerization process has been carried out, the teeth are obtained and the next step is to remove any burrs and polish them.
The provided text describes a 510(k) premarket notification for "SYNTHETIC POLYMER TEETH". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies.
Therefore, the document explicitly states:
- "Discussion of Clinical Tests Performed: None"
This means there was no clinical study conducted to establish performance and acceptance criteria for the device itself. Instead, the submission relies on the established safety and effectiveness of the predicate devices and the new device's material and manufacturing similarity to them.
As a result, I cannot provide the requested information in the format of acceptance criteria and reported device performance based on a study, as such a study was not performed as part of this 510(k) submission.
To answer your request based on the provided document, here's what can be extracted:
No Clinical Study Performed for this Device
The submission explicitly states that no clinical tests were performed to establish performance or meet specific acceptance criteria for the SYNTHETIC POLYMER TEETH.
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. No acceptance criteria were defined or measured through a clinical study for this device as part of the 510(k) submission. The submission relies on establishing substantial equivalence to predicate devices through non-clinical bench and biocompatibility testing.
2. Sample size used for the test set and the data provenance
Not applicable. No clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set and thus no ground truth established by experts for a test set.
4. Adjudication method for the test set
Not applicable. No clinical test set.
5. 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 device is a preformed plastic denture tooth, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a preformed plastic denture tooth, not an algorithm.
7. The type of ground truth used
Not applicable. No clinical study was performed requiring ground truth.
8. The sample size for the training set
Not applicable. No machine learning model was developed for this device.
9. How the ground truth for the training set was established
Not applicable. No machine learning model was developed for this device.
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Summary Prepared Date: 03/26/2010
Submission Sponsor:
:
AUG 1 6 2010
HUGE DENTAL MATERIAL CO., LTD. No.5069 Chuannanfeng Rd, Zhuqiao, Nanhui Shanghai, China 201323 Phone: +86-21-61629296 Fax: +86-21-61629298 www.hugedental.com
Submission Correspondent:
Mr. Leon Lu Director of Regulatory Affairs
MEDevice Services, LLC 3500 South Dupont Highway Dover, Delaware 19901 USA Phone: 1-877-202-1588 Fax: 1-888-202-8884 Email: info@medeviceservices.com www.medeviceservices.com
Trade/Device Name: SYNTHETIC POLYMER TEETH (Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, MAIST and Kaitong/Royal)
Common or Usual Name: Preformed Plastic Denture Teeth Device Class: II Classification Name: Preformed Plastic Denture Tooth Regulation Number: 21 CFR 872.3590 Product Code: ELM Review Panel: Dental
Predicate Device:
- K061337, XPDENT CORPORATION ● WIEDENT ESTHETIC TEETH
- . K070591, UNION DENTAL S.A./UNIDESA.ODI REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH
- K022300, DENTAL VIPI LTDA . ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V PERFORMED PLASTIC DENTURE TEETH
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The device is similar in size, shape, color, chemical composition and usage as the above products.
Device Description:
- D
ﺎ
The Synthetic Polymer Teeth (Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, MAIST and Kaitong/Royal) used in the production of dentures are produced through a dough molding process. Polymethylmethacrylate (PMMA) is mixed with methylmethacrylate monomer and a crosslinking agent.
Once the polymerization process has been carried out, the teeth are obtained and the next step is to remove any burrs and polish them.
Intended Use:
It is intended for use as a tooth in a denture.
These teeth are used for making full or partial dentures. The artificial resin teeth are mounted on an appliance made of dental acrylic resin. The appliance is made to fit the patient's mouth and is a removable. It is not implanted.
Comparison to Predicate Devices:
The device has comparable chemical composition as the predicate devices.
The device is similar in size, shape, color and usage as the predicate devices.
Discussion of Non-Clinical Tests Performed:
Performance and safety testing activities were conducted against recognized standards to establish the reliability characteristics of the new devices. Testing involved bench studies, and biocompatibility tests.
Discussion of Clinical Tests Performed:
None
Conclusion:
The proposed device is as safe and effective as the predicate devices. The proposed device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the proposed device and its predicate devices raise no new issues of safety or effectiveness. Thus, the Synthetic Polymer Teeth (Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, MAIST and Kaitong/Royal) is substantially equivalent to its predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Huge Dental Material Company, Limited C/O Mr. Jing Li MEDevice Services, LLC 3500 South Dupont Highway Dover, Delaware 19901
AUG 1 6 2010
Re: K101029
Trade/Device Name: SYNTHETIC POLYMER TEETH (Kaifeng/ Crystal, Kaili, Kaijing, Kaiyue, MAIST and Kaitong/ Royal) Regulation Number: 21 CFR 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: ELM Dated: July 12, 2010 Received: July 22, 2010
Dear Mr. Li:
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. Li
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 yours,
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, 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: SYNTHETIC POLYMER TEETH (Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, MAIST and Kaitong/Royal)
Indications for Use:
It is intended for use as a tooth in a denture.
These teeth are used for making full or partial dentures. The artificial resin teeth are mounted on an appliance made of dental acrylic resin. The appliance is made to fit the patient's mouth and is a removable. It is not implanted.
Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)
Kei Mulyani MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K101029
§ 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.