(124 days)
Not Found
No
The summary describes a preformed plastic denture tooth and its materials. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The device is a preformed plastic denture tooth, which serves as a component in a denture for tooth replacement, not for treating a disease or condition.
No
The device description clearly states its intended use is as artificial teeth for dental restorations and prostheses, which is a manufacturing component, not a diagnostic tool.
No
The device description clearly states it is a preformed plastic denture tooth made of materials like methyl methacrylate, indicating a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a "tooth in a denture," which is a physical component of a dental prosthesis.
- Device Description: The description focuses on the material composition and its use in fabricating dental restorations and prostheses.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are typically used in vitro (outside the body) to analyze biological samples.
This device is a medical device, specifically a dental prosthesis component, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes
ELM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental laboratory only
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
>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
1
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.
3
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