JUVORA Dental Disc, Ceramill PEEK by JUVORA

K160918 · Juvora · EBI · Feb 13, 2017 · Dental

Device Facts

• Record ID: K160918
• Device Name: JUVORA Dental Disc, Ceramill PEEK by JUVORA
• Applicant: Juvora
• Product Code: EBI · Dental
• Decision Date: Feb 13, 2017
• 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. They are intended to be used for the manufacture of: i) full and partial removable dentures and implant overdentures. ii) copings, substructures (cemented or uncemented), frameworks for permanent and transitional anterior or posterior crowns and bridgework.

Device Story

JUVORA Dental Disc is a cylindrical, puck-shaped thermoplastic disc composed of PEEK-OPTIMA LT1 polymer. Used by dental laboratories as raw material for CAD/CAM milling of dental prostheses, including removable dentures, implant overdentures, crowns, and bridgework. The disc is non-sterile and single-use. The laboratory technician uses CAD/CAM software to design the restoration and a milling machine to transform the disc into the final prosthetic shape. The finished device is then provided to the dentist for clinical placement. The PEEK material provides a durable, biocompatible framework for dental restorations, offering an alternative to traditional metal or ceramic materials. The device is intended for prescription use only.

Clinical Evidence

Bench testing only. Mechanical testing performed per ISO 10477, ISO 20795, and ISO 7405. Biocompatibility testing performed per ISO 10993. No clinical data provided.

Technological Characteristics

Material: PEEK-OPTIMA LT1 polymer. Form factor: Cylindrical discs (various diameters/thicknesses). Manufacturing: CAD/CAM milling. Mechanical properties: Flexural strength 192 MPa (ISO 10477), 165 MPa (ISO 20795), 194 MPa (ISO 6872); Flexural modulus 3995 MPa (ISO 20795). Water absorption 5 µg/mm3 (ISO 20795). Non-sterile, single-use.

Indications for Use

Indicated for patients requiring full or partial removable dentures, implant overdentures, or permanent/transitional anterior or posterior crowns and bridgework (including copings and substructures).

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

• JUVORA Dental Disc (K132725)

Reference Devices

• TRINIA (K133608)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 13, 2017

Juvora, Ltd. Tim Leyva Regulatory Leader -United States Technology Centre, Hillhouse International Thornton-cleveleys, FY5 40D GB

Re: K160918

Trade/Device Name: Juvora Dental Disc, Ceramill Peek By Juvora Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI, EBF, EBG Dated: January 19, 2017 Received: January 23, 2017

Dear Tim Leyva:

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.

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 devicerelated 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.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runna DDS, MA

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K160918

Device Name JUVORA™ Dental Disc

#### Indications for Use (Describe)

The JUVORA™ Dental Disc is a thermoplastic dental disc. They are intended to be used for the manufacture of:

i) full and partial removable dentures and implant overdentures.

ii) copings, substructures (cemented), frameworks for permanent and transitional anterior or posterior crowns and bridgework.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| Prescription Use (Part 81 CFR 201 Subpart D) | <span style="font-size: 20px;">☑</span> |
|----------------------------------------------|-----------------------------------------|
| Over-The-Counter Use (21 CFR 201 Subpart C) | <span style="font-size: 20px;">☐</span> |

> Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Juvora Dental Innovations. The logo features a stylized letter "J" in a dark purple color, with a crown on top and a curved line underneath. To the right of the "J" is the word "JUVORA" in a gray sans-serif font, with the words "DENTAL INNOVATIONS" in a smaller font below.

# K160918

# I. SUBMITTER

| Name: | Juvora, Ltd. |
|-----------------------------------|---------------------------------------------------------------------------------------------|
| Address: | Technology Centre, Hillhouse International<br>Thornton-Clevelys<br>Lancashire FY5 4QD<br>UK |
| Phone: | 484.354.4185 |
| Email: | [e-mail] |
| Contact Person: | Tim Leyva |
| Date Prepared: | January 10, 2017 |
| II. DEVICE | |
| Name of Device: | JUVORA™ Dental Disc |
| Common or Usual Name: | Dental Resin |
| Product Code &<br>Classification: | EBI - Denture Relining, Repairing, Rebasing Resin<br>21 CFR 872.3760 |
| | EBG – Crown And Bridge, Temporary, Resin<br>21 CFR 872.3770 |
| | EBF - Material, Tooth Shade, Resin<br>21 CFR 872.3690 |
| Regulatory Class: | II |

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Juvora Dental Innovations. The logo features a stylized letter "J" with a crown on top, colored in purple. To the right of the "J" is the word "JUVORA" in gray, with the words "DENTAL INNOVATIONS" in smaller gray font underneath.

### III. PREDICATE DEVICE

| 510(k) Number | Trade or Proprietary or Model<br>Name | Manufacturer | TYPE |
|---------------|---------------------------------------|--------------|------------------|
| K132725 | JUVORA™ DENTAL DISC | Juvora, Ltd. | Predicate Device |
| K133608 | TRINIA | Bicon, LLC | Reference Device |

#### IV. DEVICE DESCRIPTION

JUVORA™ Dental Discs are cylindrical, puck-shaped discs made from the polymer, PEEK-OPTIMA™ LT1, that are used in the CAD/CAM manufacture of removable dental prostheses. The disc is provided non-sterile, without any accessories, and are single use.

The JUVORA™ Dental Discs are provided in a variety of sizes:

Ø 95 x 16 mm Ø 95 x 20 mm Ø 98 x 16 mm Ø 98 x 18 mm Ø 98 x 20 mm Ø 98 x 22 mm Ø 98 x 25 mm Ø 98 x 30 mm Ø 101 x 13 mm

Ø 101 x 20 mm

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Juvora Dental Innovations. The logo features a stylized letter "J" in a dark purple color, with a crown-like design at the top and a curved line at the bottom. To the right of the "J" is the word "JUVORA" in a gray sans-serif font, and below that, in smaller letters, is the phrase "DENTAL INNOVATIONS".

# V. INDICATIONS FOR USE

The JUVORA™ Dental Disc is a thermoplastic dental disc. They are intended to be used for the manufacture of:

i) full and partial removable dentures and implant overdentures.

ii) copings, substructures (cemented or uncemented), frameworks for permanent and transitional anterior or posterior crowns and bridgework.

| | New Device | Predicate Device | Reference Device |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Juvora, Ltd. | Juvora, Ltd. | Bicon, LLC |
| Trade Name | JUVORA™ DENTAL<br>DISC | JUVORA™ DENTAL<br>DISC | TRINIA |
| 510(k) Number | K160918 | K132725 | K133608 |
| Indications for Use | The Juvora Dental<br>Disc is a<br>thermoplastic dental<br>disc. They are<br>intended to be used<br>for the manufacture<br>of:<br>i) full and partial<br>removable dentures<br>and implant<br>overdentures.<br><br>ii) copings,<br>substructures<br>(cemented or<br>uncemented),<br>frameworks for<br>permanent and<br>transitional anterior<br>or posterior crowns<br>and bridgework. | The Juvora Dental Disc<br>is a thermoplastic<br>dental disc for the<br>manufacture of full<br>and partial removable<br>dentures and implant<br>overdentures. | Fiber Disks and Blocks<br>(TRINIA) are intended to<br>be used for making<br>copings, substructures,<br>removable dentures, or<br>frameworks for<br>permanent and<br>transitional anterior or<br>posterior crowns,<br>bridgework, and<br>substructures that can<br>be for either cemented<br>or uncemented<br>restorations (e.g.<br>telescopic restorations). |
| | New Device | Predicate Device | Reference Device |
| Material | PEEK-OPTIMA™ LT1 | PEEK-OPTIMA™ LT1 | Glass fiber<br>Modified epoxy resin |
| Shape | Disc | Disc | Disc |
| Flexural Strength | 192 MPa<br>(ISO 10477)<br><br>165 MPa<br>(ISO 20795)<br><br>194 MPa<br>(ISO 6872) | 192 MPa<br>(ISO 10477)<br><br>165 MPa<br>(ISO 20795)<br><br>194 MPa<br>(ISO 6872) | 393 MPa<br>(ISO 14125) |
| Flexural Modulus | 3995 MPa<br>(ISO 20795) | 3995 MPa<br>(ISO 20795) | 18.8 GPa<br>(ISO 14125) |
| Water Absorption | 5 (μg/mm3)<br>(ISO 20795)<br><br>5.0 (µg/mm3)<br>(ISO 10477)<br><br>0.5% (wt)<br>(ISO 62) | 5 (μg/mm3)<br>(ISO 20795)<br><br>5.0 (µg/mm3)<br>(ISO 10477)<br><br>0.5% (wt)<br>(ISO 62) | 0.03% |
| Shear Bond Test | Dental composite<br>veneer system (GC<br>Gradia, GC)<br>27.3 MPa<br>(ISO TR 11405)<br><br>Dental cement<br>system<br>(RelyXUltimate, 3M<br>ESPE)<br>21.2 MPa<br>(ISO TR 11405) | Dental composite<br>veneer system (GC<br>Gradia, GC)<br>27.3 MPa<br>(ISO TR 11405)<br><br>Dental cement system<br>(RelyXUltimate, 3M<br>ESPE)<br>21.2 MPa<br>(ISO TR 11405) | - |
| Technology | Polymer disc for the<br>manufacture of<br>dental frameworks in<br>accordance with<br>indications of use | Polymer disc for the<br>manufacture of dental<br>frameworks in<br>accordance with<br>indications of use | Polymer disc for the<br>manufacture of dental<br>frameworks in<br>accordance with<br>indications of use |
| | New Device | Predicate Device | Reference Device |
| Principles of Operation | The dental disc is to be converted into dental frameworks using CAD/CAM technology (computer-aided design and computer-aided manufacturing) | The dental disc is to be converted into dental frameworks using CAD/CAM technology (computer-aided design and computer-aided manufacturing) | The dental disc is to be converted into dental frameworks using CAD/CAM technology (computer-aided design and computer-aided manufacturing) |

## VI. TECHNOLOGICAL CHARACTERISTICS

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for Juvora Dental Innovations. The logo consists of a stylized letter "J" in purple with a crown on top and a curved line underneath. To the right of the "J" is the word "JUVORA" in gray, with the words "DENTAL INNOVATIONS" in a smaller font size underneath.

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for Juvora Dental Innovations. The logo features a stylized letter "J" in purple with a crown-like design at the top. To the right of the "J" is the word "JUVORA" in a gray sans-serif font, and below that, in smaller letters, is the phrase "DENTAL INNOVATIONS".

JUVORA™ is expanding the indications for use for the JUVORA™ Dental Disc (510(k) K132725) to include copings, substructures, frameworks for permanent and transitional anterior or posterior crowns and bridgework. The predicate device is Juvora's own device.

### VII. NON-CLINICAL PERFORMANCE DATA

The JUVORA™ Dental Disc has been tested in the following test modes:

- . Mechanical testing per ISO 10477, ISO 20795 and ISO 7405.
- . Biocompatibility for material composition of PEEK-OPTIMA™ per ISO 10993.

The results of this non-clinical testing show that the strength of the JUVORA™ Dental Disc is sufficient for its intended use and is substantially equivalent to the legally marketed predicate device.

#### VIII. CONCLUSIONS

The overall technology characteristics and mechanical performance data lead to the conclusion that the JUVORA™ Dental Disc is substantially equivalent to the predicate device.