JUVORA DENTQAL DISC

K132725 · Juvora · EBI · Jan 23, 2014 · Dental

Device Facts

• Record ID: K132725
• Device Name: JUVORA DENTQAL DISC
• Applicant: Juvora
• Product Code: EBI · Dental
• Decision Date: Jan 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Juvora Dental Disc is a thermoplastic dental disc for the manufacture of full and partial removable dentures and implant overdentures.

Device Story

Juvora Dental Disc is a cylindrical, puck-shaped thermoplastic disc composed of implant-grade PEEK-OPTIMA LT1 polymer. It serves as a raw material for the CAD/CAM fabrication of removable dental prostheses, including full dentures, partial dentures, and implant overdentures. The device is intended for use by dental professionals in a laboratory or clinical setting to mill custom prosthetic appliances. By utilizing high-performance PEEK material, the device provides a durable, biocompatible alternative to traditional denture base resins. The final output is a patient-specific dental prosthesis that restores oral function and aesthetics.

Clinical Evidence

Bench testing only. Compliance with ISO 20795-1 (Denture Base Polymers) for strength and ISO 7405/ISO 10993-1 for biocompatibility. Biocompatibility assessment for permanent mucosal contact showed no evidence of cytotoxicity, systemic toxicity, or irritation.

Technological Characteristics

Material: PEEK-OPTIMA LT1 (implant-grade polymer). Form factor: Cylindrical, puck-shaped discs (with or without step). Standards: ISO 20795-1 (strength), ISO 7405 and ISO 10993-1 (biocompatibility). Manufacturing: CAD/CAM milling.

Indications for Use

Indicated for the manufacture of full and partial removable dentures and implant overdentures in patients requiring dental prosthetic restoration.

Regulatory Classification

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.

Predicate Devices

• Vertex Thermosens Rigid (K123220)
• Paladon Ultra (K111832)

Submission Summary (Full Text)

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- 5. 510(k) Summarv
K132725

Company:

Date:

October 24, 2013

Juvora

Contact Person:

Selina Shaw Technology Centre Hillhouse International Thornton-Clevelys Lancashire FY5 4QD பா Tel: [phone] Fax: [phone] 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

- Vertex Thermosens Rigid (K123220) .
- Paladon Ultra (K111832) .

## 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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to convey the department's mission of protecting and promoting the health and well-being of Americans.

#### 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 [phone] or [phone] 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 [phone] or [phone] 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):

K132725

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)

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