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

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Juvora Dental Disc, and evaluates its substantial equivalence to a predicate device. This document is a regulatory submission for a medical device and therefore primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed device.

Unfortunately, this type of regulatory document does not typically include the detailed information required to answer your questions about acceptance criteria, specific study results, sample sizes, ground truth establishment, or expert-driven studies (like MRMC or standalone AI performance). These elements are much more common in publications and regulatory filings for AI/ML-driven diagnostic devices, especially those that provide clinical insights or automate diagnostic tasks.

The Juvora Dental Disc is a physical dental material (a thermoplastic disc) used for manufacturing dental prostheses (dentures, crowns, bridgework). The "performance" in this context refers to its physical and biocompatibility properties, not the performance of an AI algorithm.

However, I can extract the information that is present and explain why other information is not available in this document.

1. A table of acceptance criteria and the reported device performance

The document compares the new device (K160918) to its predicate device (K132725) and a reference device (K133608) based on various material properties. While explicit "acceptance criteria" for each parameter aren't stated as numeric thresholds (e.g., "must be > X MPa"), the implicitly accepted performance is "substantially equivalent" to (or matching) the predicate device, or meeting relevant ISO standards.

Characteristic	Acceptance/Comparison Basis	Reported Device Performance (JUVORA™ Dental Disc K160918)	Predicate Device Performance (JUVORA™ Dental Disc K132725)	Reference Device Performance (TRINIA K133608)
Flexural Strength	Comparison to predicate and reference devices; ISO 10477, ISO 20795, ISO 6872 standards. Implied acceptance is substantial equivalence to predicate.	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	Comparison to predicate and reference devices; ISO 20795 standard. Implied acceptance is substantial equivalence to predicate.	3995 MPa (ISO 20795)	3995 MPa (ISO 20795)	18.8 GPa (ISO 14125)
Water Absorption	Comparison to predicate and reference devices; ISO 20795, ISO 10477, ISO 62 standards. Implied acceptance is substantial equivalence to predicate.	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	Comparison to predicate device; ISO TR 11405 standard. Implied acceptance is substantial equivalence to predicate.	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)	-
Biocompatibility	Compliance with ISO 10993 for PEEK-OPTIMA™ material composition. Implicit acceptance is meeting the standard.	"Biocompatibility for material composition of PEEK-OPTIMA™ per ISO 10993." (Stated as having been tested and results contributing to substantial equivalence conclusion).	"Biocompatibility for material composition of PEEK-OPTIMA™ per ISO 10993." (Implicitly accepted as compliant, as it's the predicate device.)	Not applicable/provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the document. The physical and mechanical testing (e.g., flexural strength, water absorption, shear bond) would have involved multiple samples, but the exact number for each test is not provided in this regulatory summary.
Data Provenance: The tests were conducted to international ISO standards (e.g., ISO 10477, ISO 20795, ISO 6872, ISO TR 11405, ISO 62, ISO 10993). This implies standard laboratory testing, likely by the manufacturer or a contracted lab. The country of origin of the data is not specified, but the manufacturer is Juvora, Ltd. based in the UK. The studies are prospective in nature, as they involve testing newly manufactured materials according to established protocols.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this device submission. This is a material science and biocompatibility submission, not an AI/ML diagnostic device. "Ground truth" in this context refers to the measured physical and chemical properties of the material, not expert clinical diagnoses. The "truth" is established by adhering to the specified ISO testing standards and methodologies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 refer to consensus-building among multiple human reviewers for tasks like image interpretation or clinical diagnosis. This document pertains to material property testing, where the "truth" is derived from standardized physical measurements, not human interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. MRMC studies are specific to evaluating AI/ML systems in diagnostic imaging or similar contexts where human readers interact with AI assistance. This device is a dental material, not an AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This question relates to the performance of an AI algorithm. The device is a physical dental material.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's evaluation is primarily:

Physical and Mechanical Properties: Measured values obtained through standardized laboratory testing following ISO (International Organization for Standardization) standards (e.g., flexural strength, flexural modulus, water absorption, shear bond strength). These are objective measurements.
Biocompatibility: Established by testing the material's composition (PEEK-OPTIMA™) against ISO 10993 standards, which define biological evaluation of medical devices.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." It's a manufactured material, and its properties are inherent to its composition and manufacturing process, not learned from data.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for this type of device.

Summary

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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.

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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

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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 InternationalThornton-ClevelysLancashire FY5 4QDUK
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 Resin21 CFR 872.3760
	EBG – Crown And Bridge, Temporary, Resin21 CFR 872.3770
	EBF - Material, Tooth Shade, Resin21 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 ModelName	Manufacturer	TYPE
K132725	JUVORA™ DENTAL DISC	Juvora, Ltd.	Predicate Device
K133608	TRINIA	Bicon, LLC	Reference Device

IV. DEVICE DESCRIPTION

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™ DENTALDISC	JUVORA™ DENTALDISC	TRINIA
510(k) Number	K160918	K132725	K133608
Indications for Use	The Juvora DentalDisc is athermoplastic dentaldisc. They areintended to be usedfor the manufactureof:i) full and partialremovable denturesand implantoverdentures.ii) copings,substructures(cemented oruncemented),frameworks forpermanent andtransitional anterioror posterior crownsand bridgework.	The Juvora Dental Discis a thermoplasticdental disc for themanufacture of fulland partial removabledentures and implantoverdentures.	Fiber Disks and Blocks(TRINIA) are intended tobe used for makingcopings, substructures,removable dentures, orframeworks forpermanent andtransitional anterior orposterior crowns,bridgework, andsubstructures that canbe for either cementedor uncementedrestorations (e.g.telescopic restorations).
	New Device	Predicate Device	Reference Device
Material	PEEK-OPTIMA™ LT1	PEEK-OPTIMA™ LT1	Glass fiberModified 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 compositeveneer system (GCGradia, GC)27.3 MPa(ISO TR 11405)Dental cementsystem(RelyXUltimate, 3MESPE)21.2 MPa(ISO TR 11405)	Dental compositeveneer system (GCGradia, GC)27.3 MPa(ISO TR 11405)Dental cement system(RelyXUltimate, 3MESPE)21.2 MPa(ISO TR 11405)	-
Technology	Polymer disc for themanufacture ofdental frameworks inaccordance withindications of use	Polymer disc for themanufacture of dentalframeworks inaccordance withindications of use	Polymer disc for themanufacture of dentalframeworks inaccordance withindications 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.

Regulation Number and Section

§ 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.