(146 days)
The Juvora Dental Disc is a thermoplastic dental disc for the manufacture of full and partial removable dentures and implant overdentures.
JUVORA™ Dental Discs are cylindrical, puck-shaped discs made from the implantgrade polymer, PEEK-OPTIMA® LT1, that are used in the CAD/CAM manufacture of removable dental prostheses. The discs are provided either with or without a step.
Here's an analysis of the provided text regarding the Juvora Dental Disc's acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ISO 20795-1 (Denture Base Polymers) Strength | Testing performed in compliance; demonstrates sufficient strength for proposed indications. |
| ISO 7405 (Biocompatibility) | Assessed according to ISO 10993-1:2009; categorised for permanent contact with mucosal membrane. Tested and showed no evidence of cytotoxicity, systemic toxicity, irritation, or macroscopic reaction. No harmful leachable ingredients/residues. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in the non-clinical performance data or the biocompatibility testing. It only mentions "testing is performed in compliance with applicable clauses" and "JUVORA™ Dental Disc has been assessed in terms of biocompatibility."
The data provenance is not specified beyond the company, Juvora (located in the UK), conducting the tests. It is implied these were internal studies conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text. The studies appear to be laboratory-based non-clinical performance and biocompatibility testing, which typically rely on standardized methods and measurements rather than expert consensus on a "ground truth" in the same way clinical studies might.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. The studies described are non-clinical, laboratory-based tests for material properties and biocompatibility, not studies involving human interpretation or subjective assessments that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable and not provided. The Juvora Dental Disc is a material for dental prostheses, not an AI-powered diagnostic or assistive device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. As explained above, this device is a material, not an algorithm.
7. The Type of Ground Truth Used
For non-clinical performance data (strength): The "ground truth" is established by the specified standards and their methodologies, such as ISO 20795-1. The material's properties (e.g., flexural strength, water sorption) are measured and compared against the limits defined by these international standards.
For biocompatibility testing: The "ground truth" is established by the methods and criteria outlined in ISO 10993-1:2009 and ISO 7405:2008. This involves specific biological endpoints (cytotoxicity, systemic toxicity, irritation, etc.) which, when tested, determine if the material elicits an unacceptable biological response.
8. The Sample Size for the Training Set
This information is not provided and not applicable. The Juvora Dental Disc is a physical material, not a machine learning model, so there is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and not applicable for the same reason as in point 8.
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- 510(k) Summarv
K132725
- 510(k) Summarv
Company:
Date:
October 24, 2013
Juvora
Contact Person:
Selina Shaw Technology Centre Hillhouse International Thornton-Clevelys Lancashire FY5 4QD பா Tel: +44 (0)1253 898000 Fax: +44 (0)1253 898001 Date of Preparation: 27th August 2013
Proprietary Name: Juvora Dental Disc
Common Name: ิ Dental resin
Denture Relining, Repairing, Rebasing Resin (21 CFR 872.3760, Product Code EBI: Regulatory Class II)
Legally Marketed Devices to Which Substantial Equivalence Is Claimed
Device Description
Classification:
JUVORA™ Dental Discs are cylindrical, puck-shaped discs made from the implantgrade polymer, PEEK-OPTIMA® LT1, that are used in the CAD/CAM manufacture of removable dental prostheses. The discs are provided either with or without a step.
Indications for Use
The Juvora Dental Disc is a thermoplastic dental disc for the manufacture of full and partial removable dentures and implant overdentures.
Summary of Technological Characteristics
The Juvora Dental Disc has similar indications for use as the predicates: Vertex Thermosens Rigid (K123220) and Paladon Ultra (K111832). The Juvora Dental Disc and predicate devices are made from different thermoplastics but meet the same recognized standards in regards to strength (ISO 20795-1 Denture Base Polymers) and biocompatibility (ISO 7405 - Dentistry Evaluation of biocompatibility of medical devices used in dentistry).
Summary of Non-Clinical Performance Data
Testing is performed in compliance with applicable clauses of ISO 20795-1 (Equivalent to ANSI/ADA Specification No. 12:2002/ISO 1567:1999 - Denture Base Polymers).
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Image /page/1/Picture/0 description: The image shows the logo for JUVORA dental innovations. The logo consists of a stylized letter J with a crown on top and a curved line at the bottom. To the right of the J is the word "JUVORA" in capital letters, and below that are the words "DENTAL INNOVATIONS" in smaller letters.
Substantial Equivalence Conclusion
Results from the testing to ISO 20795-1 and substantial equivalence justification provided within this 510(k) demonstrate that the Juvora Dental Disc is as safe and effective and performs as well as the predicate devices for the proposed indications.
Summary of Biocompatibility Testing
The standard: Dentistry - Evaluation of biocompatibility of medical devices used in dentistry ISO 7405:2008 and the JUVORA™ Dental Disc has been assessed in terms of biocompatibility according to ISO 10993-1:2009, Evaluation and testing within a risk management process. Using ISO 10993-1:2009 the JUVORA™ Dental Disc was categorised: permanent contact with the mucosal membrane and has been tested accordingly and is biocompatible. The results of the tests completed demonstrate no evidence of cytotoxicity, systemic toxicity, irritation or any macroscopic reaction response. As there is no evidence that any harmful leachable ingredient and/or residues are contained and/or released, no further toxicity was required on the JUVORA™ Dental Disc.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2014
JUVORA Dental Innovations Ms. Selina Shaw Regulatory Affairs Officer Technology Centre Hillhouse International Thornton-Clevelys Lancashire, FY5 4QD UK
Re: K132725
Trade/Device Name: JUVORATM Dental Disc Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: October 24, 2013 Received: October 25, 2013
Dear Ms. Shaw:
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 - Ms. Shaw
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportalProblem/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.
Image /page/3/Picture/7 description: The image shows the name Kwame O. Ulmer in bold black font. Below the name is the acronym FDA in a stylized font. The acronym is in a lighter color than the name. The letter S is on the left side of the image.
for
Erin I. Keith, M.S. Acting 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 Statement
510(k) Number (if known):
Device Name: Juvora Dental Disc
INDICATIONS FOR USE:
The Juvora Dental Disc is a thermoplastic dental disc for the manufacture of full and partial removable dentures and implant overdentures.
Prescription Use X (Part 21 CFR 801 Subpart D) and/or
Over-The-Counter Use (21 CFR 807 Subpart C)
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
Mary S. Runner -S
DOSIM 2014.01.22
13:17:32 -05'00'
Traditional 510(K)
Page 12 of 157
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.