(315 days)
No
The summary describes a material (a polymer disc) used in CAD/CAM manufacturing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a material (thermoplastic dental disc) used to manufacture dental prostheses, not a therapeutic device itself.
No
The device is a material (thermoplastic dental disc) used for the manufacture of dental prostheses, not for diagnosing conditions.
No
The device is a physical dental disc made from a polymer, intended for CAD/CAM manufacture of dental prostheses. It is a hardware component, not software.
Based on the provided information, the JUVORA™ Dental Disc is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for the manufacture of dental prostheses (dentures, crowns, bridges, etc.). This is a manufacturing material for medical devices, not a device used to perform tests on samples taken from the human body to provide diagnostic information.
- Device Description: The description details a physical disc made of a polymer used in CAD/CAM manufacturing. This aligns with a material for creating dental devices, not a diagnostic tool.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health condition
- Reagents, calibrators, or controls
- Any form of testing or analysis of biological material
The testing mentioned (mechanical and biocompatibility) is related to the material properties and safety for use in the body, which is standard for implantable or long-term contact medical devices, not IVDs.
N/A
Intended Use / 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), frameworks for permanent and transitional anterior or posterior crowns and bridgework.
Product codes
EBI, EBF, EBG
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
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Pretermind Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 201 Subpart C) | ☐ |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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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 |
| Thornton-Clevelys | |
| Lancashire FY5 4QD | |
| UK | |
| Phone: | 484.354.4185 |
| Email: | tim.leyva@invibio.com |
| 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 & | |
| Classification: | EBI - Denture Relining, Repairing, Rebasing Resin |
| 21 CFR 872.3760 | |
| EBG – Crown And Bridge, Temporary, Resin | |
| 21 CFR 872.3770 | |
| EBF - Material, Tooth Shade, Resin | |
| 21 CFR 872.3690 | |
| Regulatory Class: | II |
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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
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
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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 | ||
| DISC | JUVORA™ DENTAL | ||
| DISC | TRINIA | ||
| 510(k) Number | K160918 | K132725 | K133608 |
| 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. | The Juvora Dental Disc
is a thermoplastic
dental disc for the
manufacture of full
and partial removable
dentures and implant
overdentures. | Fiber Disks and Blocks
(TRINIA) are intended to
be used for making
copings, substructures,
removable dentures, or
frameworks for
permanent and
transitional anterior or
posterior crowns,
bridgework, and
substructures that can
be for either cemented
or uncemented
restorations (e.g.
telescopic restorations). |
| | New Device | Predicate Device | Reference Device |
| Material | PEEK-OPTIMA™ LT1 | PEEK-OPTIMA™ LT1 | Glass fiber
Modified epoxy resin |
| Shape | Disc | Disc | Disc |
| Flexural Strength | 192 MPa
(ISO 10477)
165 MPa
(ISO 20795)
194 MPa
(ISO 6872) | 192 MPa
(ISO 10477)
165 MPa
(ISO 20795)
194 MPa
(ISO 6872) | 393 MPa
(ISO 14125) |
| Flexural Modulus | 3995 MPa
(ISO 20795) | 3995 MPa
(ISO 20795) | 18.8 GPa
(ISO 14125) |
| Water Absorption | 5 (μg/mm3)
(ISO 20795)
5.0 (µg/mm3)
(ISO 10477)
0.5% (wt)
(ISO 62) | 5 (μg/mm3)
(ISO 20795)
5.0 (µg/mm3)
(ISO 10477)
0.5% (wt)
(ISO 62) | 0.03% |
| Shear Bond Test | Dental composite
veneer system (GC
Gradia, GC)
27.3 MPa
(ISO TR 11405)
Dental cement
system
(RelyXUltimate, 3M
ESPE)
21.2 MPa
(ISO TR 11405) | Dental composite
veneer system (GC
Gradia, GC)
27.3 MPa
(ISO TR 11405)
Dental cement system
(RelyXUltimate, 3M
ESPE)
21.2 MPa
(ISO TR 11405) | - |
| Technology | Polymer disc for the
manufacture of
dental frameworks in
accordance with
indications of use | Polymer disc for the
manufacture of dental
frameworks in
accordance with
indications of use | Polymer disc for the
manufacture of dental
frameworks in
accordance with
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
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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.
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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.