(124 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.
gebdi Tribos 501 artificial teeth devices are chemically based on polymethacrylate-polymers and their geod Thirddin tectif devices are enternitures are used when fabricating any kind of dental chemical properties. These provisional restaurations and/or removable dental prostheses at the dental laboratory only.
This document is a 510(k) summary for the gebdi Tribos 501, a preformed plastic denture tooth. It establishes substantial equivalence to a predicate device (K790439 - Vivadent (USA) Inc.) rather than demonstrating de novo performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and sample sizes for performance evaluation is not applicable to this type of submission.
Here's an analysis based on the provided text, highlighting what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. This 510(k) submission establishes substantial equivalence to a predicate device, K790439. It does not define specific performance acceptance criteria for the new device as would be seen in a clinical trial or performance study for a novel device. The core argument is that the gebdi Tribos 501 is "similar to the P.D. in terms of technical characteristics, design, Indications for Use, ... performance, biocompatibility characteristics as well as sizes and target population."
The summary states: "The presented data that was conducted on the gebdi products shows in its results and in comparison to the predicate devices that the products are absolutely safe and effective for their intended use and do not raise any questions regarding safety and effectiveness."
This statement implies a comparison was made, but not against pre-defined, quantitative acceptance criteria for performance; rather, it refers to a qualitative comparison demonstrating similarity in performance to the predicate.
2. Sample size used for the test set and the data provenance
Not Applicable. No "test set" in the context of a performance study (e.g., clinical trial with patient data) is mentioned. The submission is based on a comparison to a predicate device and existing market history.
- The document notes: "All models that are covered by this 510(k) premarket notification have been on the market in Europe for many years with no safety or functional failures." This suggests historical data or market surveillance in Europe, but no specific sample size from a controlled test set is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. No independent expert review or ground truth establishment for a specific test set is described. The equivalency is asserted based on characteristics and previous market performance.
4. Adjudication method for the test set
Not Applicable. As no specific test set requiring adjudication is mentioned, no adjudication method is provided.
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 passive, preformed dental product, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effectiveness are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. As noted above, this is a physical dental device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not Applicable. Ground truth in the context of a validation study (e.g., for diagnostic accuracy) is not relevant to this 510(k) submission. The safety and effectiveness are established through substantial equivalence to a legally marketed predicate device, backed by historical market performance in Europe.
8. The sample size for the training set
Not Applicable. This is a physical device, and therefore the concept of a "training set" (as used in machine learning or AI context) does not apply.
9. How the ground truth for the training set was established
Not Applicable. As no training set is relevant, no ground truth establishment for it is described.
In summary, the provided text describes a 510(k) premarket notification for a dental device (gebdi Tribos 501 preformed plastic denture tooth). The submission relies on demonstrating substantial equivalence to a predicate device (Vivadent (USA) Inc. K790439) in terms of materials, design, indications for use, performance, and biocompatibility. It also mentions that the product has been on the European market for many years "with no safety or functional failures," further supporting its safety and effectiveness. This type of submission generally does not involve the detailed performance studies, acceptance criteria, or ground truth establishment that would be seen for novel devices requiring clinical validation or AI algorithm performance assessment.
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>Summary
510(k) Summary as required by section 807.92(c)
Date: 10/29/09
Submission Applicont: gebdi Dental-Products GmbH Industriestr. 3a 78234 Engen
Phone: xx49-7733-9410-0 Fox: xx49-7733-6434 E-mail: info@gebdi-dental.com
Application corresondent/Contact person: gebdi Dental-Products GmbH Jasmin Jung Industriestr. 3a 78234 Engen
Phone: xx49-7464-96600 Fax: xx49-7462-924128 E-mail: j.jung@bell-qm.de
Trade name: gebdi Tribos 501 K-Number: K092231
Common name: Preformed plastic tooth / artificial PMMA teeth
Classfication name: Preformed plastic denture tooth, Dental (21 CFR 872.3590 - EBF)
Substantial Equivalence Claim: K790439 - Vivadent (USA) Inc.
Description of the Device:
Description of the Device.
gebdi Tribos 501 artificial teeth devices are chemically based on polymethacrylate-polymers and their geod Thirddin tectif devices are enternitures are used when fabricating any kind of dental chemical properties. These provisional restaurations and/or removable dental prostheses at the dental laboratory only.
Application range (dental laboratory use only!):
-
implant retained dentures
-
provisional restaurations
-
hybrid dentures
-
partial dentures
-
complete dentures
-
hybrid dentures
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Indications for Use:
mbledians of Ose.
gebdi Tribos 501 are preformed plastic denture teeth as a prefabricated device, composed of materials such as methyl methacrylate, that are intended for use as a tooth in a denture
Comparison with P.D.
The gebdi product is similiar to the P.D. in terms of technical characteristics, design, Indications for Use, the geoul prouable where it is used, performance, biocompatibility characteristics as well as sizes and turget population, micro it is assul pi product can be deemed substantially equivalent and safe and effective for its indicated use.
Summary
The presented data that was conducted on the gebdi products shows in its results and in rne presented the predicate devices that the products are absolutely safe and effective for companson to the produce to traise any questions regarding safety and effectiveness. All models that are covered by this 510(k) premarket notification have been on the market in models that are cover or and and to failures. The used materials are well researched and do Europe for marry years withing safety and effectiveness of the finished product.
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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 & Human Services. The logo consists of a stylized eagle-like symbol on the right. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
NUV & 4 2009
Mr. Thomas Biskupski Managing Director gebdi Dental-Products GmbH Industriestra 3A Engen BaWu GERMANY 78234
Re: K092231
Trade/Device Name: gebdi Tribos 501 Regulation Number: 21 CFR 872.3950 Regulation Name: Glenoid Fossa Prosthesis Regulatory Class: II Product Code: ELM Dated: November 12, 2009 Received: November 12, 2009
Dear Mr. Biskupski:
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 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. Biskupski
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
for
Susan Runner, D.D.S., M.A. Acting 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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Indication for Use
510(k) Number: K092231
Device Name: gebdi Tribos 501
Indications for use: 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 devices are offered in non-sterile condition.
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 OF NEEDED)
Concurrence of DCRH, Office of Device Evaluation (ODE)
Page 01 of 01
Robert Betz, DDS for Dr. Kevin Muhlany
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092231
§ 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.