The L-OVC is a ceramic crown, and includes an anatomic occlusal layer made of lithium disilicate, a thin priming/bonding layer that assists with bonding the occlusal layer to the sub-layer of uncured hybrid ceramic that allows for customization of the L-OVC to the specific tooth preparation. The customized L-OVC is bonded to the prepared natural tooth. The L-OVC is for restoring structurally compromised posterior teeth in cases normally restored with an onlay or a partial crown in a single dental visit. The L-OVC is selected based on tooth location and size and therefore no impressions are necessary. The L-OVC is provided in designs for the upper and lower first and second premolars and second molars, and each design is provided in five (5) sizes (extra-small (XS), small (S), medium (M), large (L), and extra-large (XL)). The L-OVC is made from lithium disilicate and high-strength ceramic composite resin. The L-OVC is provided nonsterile for singlepatient, single-use only.

Accessories to the L-OVC device include the L-OVC Replica, a replica of the ceramic occlusal portion of the L-OVC. The L-OVC Replica is used to confirm that sufficient occlusal clearance was obtained during tooth preparation and to provide direct visualization of the overall 3D position of the L-OVC on the prepared tooth and the relationship with adjacent and opposing dentition. The L-OVC Replica is manufactured from a thermoplastic elastomer resin. L-OVC Wedges are accessories provided in four configurations (small right, large left and large right), and are placed interproximally to create a working surface and to block out undercuts of the preparation. The Wedges are manufactured from polyacetal resin. The Selector Keys are accessories that allow the clinician to measure the mesial-distal distance in order to choose the appropriate size L-OVC for the restoration, and are used during the curing of the uncured resin to prevent disturbing the placement of the crown. The Selector Keys are manufactured from polycarbonate resin. All accessories are provided nonsterile for singlepatient, single-use only. The Class I accessories are provided for informational purposes only.

AI/ML Overview

The provided text is a 510(k) Summary for a dental device called L-OVC, which is a ceramic crown. This document describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices. However, it explicitly states: "No clinical data were included in this submission." This means that the document does not contain information about a study that proves the device meets specific acceptance criteria based on clinical performance with human subjects.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to clinical outcomes, nor details about sample sizes for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance. These types of studies and associated data are typically part of clinical trials, which were not included in this submission.

The "Performance Data" section solely mentions non-clinical testing data used to demonstrate substantial equivalence. This non-clinical data includes:

Biocompatibility evaluation: According to ISO 10993-1, 10993-5, 10993-6, 10993-10, 10993-11, and 10993-12.
Ceramic material characterization: Flexural strength, solubility, and radioactivity according to ISO 6872.
Shelf life testing: According to ASTM F1980.

These non-clinical tests are conducted in a laboratory setting to ensure the material safety and physical properties of the device, rather than its clinical effectiveness or accuracy in a diagnostic context. The document also notes that biocompatibility testing was performed for the L-OVC Replica material due to its difference from the predicate's replica material.

The acceptance criteria in this context would be meeting the specified standards (e.g., ISO, ASTM) for these non-clinical tests, indicating the device's materials are safe and perform as designed in a laboratory environment. The "study that proves the device meets the acceptance criteria" refers to these non-clinical tests.

Summary of available information based on the provided document:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria (Non-Clinical)	Reported Device Performance (as demonstrated by testing)
Biocompatibility (ISO 10993 series)	Evaluated as per relevant ISO 10993 standards
Ceramic Material Flexural Strength (ISO 6872)	Characterized as per ISO 6872
Ceramic Material Solubility (ISO 6872)	Characterized as per ISO 6872
Ceramic Material Radioactivity (ISO 6872)	Characterized as per ISO 6872
Shelf Life (ASTM F1980)	Tested as per ASTM F1980

Note: The document states these tests were performed and provided for substantial equivalence, implying they met the relevant criteria of these standards, but does not provide specific numerical results or thresholds.

2. Sample size used for the test set and data provenance:
Not applicable for clinical performance data, as "No clinical data were included in this submission." For non-clinical tests, the sample sizes and specific test methodologies would be detailed in the test reports referenced by the ISO and ASTM standards, but these details are not provided in the summary.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
Not applicable. No clinical test set to establish ground truth for clinical performance.

4. Adjudication method for the test set:
Not applicable. No clinical test set.

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. This is a dental ceramic crown, not an AI/diagnostic imaging device, and "No clinical data were included in this submission."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a dental ceramic crown, not an algorithm.

7. The type of ground truth used:
For non-clinical tests (biocompatibility, material properties, shelf life), the "ground truth" would be established by the objective measurements and standards defined by the ISO and ASTM protocols.

8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established:
Not applicable. No training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.

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

December 21, 2016

Rhondium, Ltd % Kevin Thomas Vice President and Director Of Regulatory Affairs Paxmed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K162677

Trade/Device Name: L-OVC Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: October 5, 2016 Received: October 6, 2016

Dear Kevin Thomas:

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

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the quality systems (OS) 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 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.

Sincerely,

Susan Runno, DDS, MA

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K162677

Device Name

L-OVC

Indications for Use (Describe)

L-OVC is intended for restoration of permanent teeth with a single unit crown.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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510(k) Summary Rhondium, Ltd L-OVC

December 15, 2016

ADMINISTRATIVE INFORMATION

Manufacturer Name	Rhondium, Ltd4 Sheffield StreetKatikati, 3129, New Zealand
	Telephone:	+64 7 549 5566
	Fax:	+64 7 549 5566
Official Contact	Greer FrickerRegulatory Manager
Representative/Consultant	Kevin A. Thomas, PhDFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130
	Telephone:	+1 (858) 792-1235
	Fax:	+1 (858) 792-1236
	Email:	kthomas@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	L-OVC
Common Name	Porcelain powder
Classification Name	Porcelain powder for clinical use
Classification Regulations	21 CFR 872.6660, Class II
Product Code	EIH
Classification Panel:	Dental Products Panel
Reviewing Branch:	Dental Devices Branch

PREDICATE DEVICE INFORMATION

Primary Predicate K143694, Rhondium One-Visit-Crown (OVC), Rhondium, Ltd

Reference Predicates K100512, NobelProcera IPS e.max Crown, Nobel Biocare AB K090826, Monobond Plus, Ivoclar Vivadent, Inc. K123397, Multilink Automix, Ivoclar Vivadent, AG

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INDICATIONS FOR USE

L-OVC is intended for restoration of permanent teeth with a single unit crown.

DEVICE DESCRIPTION

PERFORMANCE DATA

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: biocompatibility evaluation according to ISO 10993-1, 10993-5, 10993-6, 10993-10, 10993-11, and 10993-12; ceramic material flexural strength, solubility, and radioactivity characterization according to ISO 6872; and shelf life testing according to ASTM F1980.

No clinical data were included in this submission.

EQUIVALENCE TO MARKETED DEVICE

The subject device is substantially equivalent in indications and design principles to the predicate devices shown above. Below is a summary table comparing the Indications for Use statements and the technological characteristics of the subject device and the predicate devices.

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			Comparison of Subject Device and Predicate Device Characteristics

	Subject Device	Primary Predicate Device	Reference Predicate Devices
Comparison	L-OVCRhondium Ltd	K143694One-Visit-Crown (OVC)Rhondium Ltd	K100512NobelProcera IPS e.maxCrownNobel Biocare AB	K090826Monobond PlusIvoclar Vivadent, Inc.	K123397Multilink AutomixIvoclar Vivadent, AG
Indications forUse	L-OVC is intended forrestoration of permanent teethwith a single unit crown.	Rhondium One-Visit-Crownis intended for restoration ofpermanent teeth with a singleunit crown.	The NobelProcera IPS e.maxCrown is indicated for use ascore structures of crowns thatwill be cemented to natural orartificial tooth abutments inthe treatment of partiallyedentulous patients as an aidin prosthetic rehabilitation.	Monobond Plus serves asbonding agent and is used tocreate a durable chemicalbond between lutingcomposites and glass/oxideceramic, metal, composite andfiber-reinforced compositerestorations.	Multilink Automix is used forthe permanent cementation ofindirect restorations where astrong bond is desired: inlays,onlays, crowns, bridges androot posts made of:• Metal and metal ceramics• All-ceramics, in particularopaque zirconium oxideceramics• Composites and fibre-reinforced composites
Description	Preformed single tooth crownfor one visit restoration	Preformed single tooth crownfor one visit restoration	Lithium disilicate ceramicintended for the fabrication ofcrowns	Primer to promote adhesivebonding between lutingcomposites and indirectrestorative materials (glassand oxide ceramics, metal,composites, fiber-reinforcedcomposites)	Self-curing luting compositewith light-curing option foradhesive luting of indirectrestorations made of metal,metal-ceramic, all-ceramicand composite
Teeth to beRestored	Upper and lower premolarsand molars	Upper and lower premolarsand molars	n/a	n/a	n/a
Specific CrownDesigns	N=8Upper Premolar, Upper MolarLower Premolar, LowerMolarEach in Left and Rightdesigns	N=8Upper Premolar, Upper MolarLower Premolar, LowerMolarEach in Left and Rightdesigns	n/a	n/a	n/a
Crown Sizes	Each design in 5 sizes:XS, S, M, L, XL	Each design in 6 sizes:XS, S, M, L, XL, XXL	n/a	n/a	n/a
Materials	Crown occlusal layer:lithium disilicate ceramicPrimer/assist bonding:Monobond Plus (K090826)Multilink Automix (K123397)Sub-layer bonded to preparedtooth:Light-cured polymercomposite resin	Crown occlusal layer:Light-cured polymercomposite resin (Ceramage,K050401)Primer/assist bonding:Complete Unfilled Resin(K052501)Sub-layer bonded to preparedtooth:Light-cured polymercomposite resin	Lithium disilicate ceramic	Silane methacrylate,phosphoric acid methacrylate,and sulfide methacrylate	Monomer matrix (60%):dimethacrylate and HEMA(2-hydroxyethyl methacrylate)Inorganic fillers (40%):barium glass, ytterbiumtrifluoride, spheroid mixedoxide
CrownProvisional(Trial) Material	Thermoplastic elastomer	Vinyl polysiloxane	n/a	n/a	n/a

The subject device and the primary predicate K143694 have similar Indications for Use statements.

The subject device and the primary predicate device have similar indications for use, the same intended use, and essentially the same designs for the individual crown components. The subject device comprises four materials: lithium disilicate substantially equivalent to the reference predicate K100512, polymer composite resin used in the same way as in the primary predicate K143694, and materials similar to those of the reference predicates K090826 and K123397. The subject device and the primary predicate device K143694 are provided in a range of designs and sizes to restore the premolars and molars of the upper and lower jaw. For the specific teeth that each device is designed to restore, both the subject device and the primary predicate device K143694 provide preformed anatomic occlusal surfaces.

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The subject device priming/bonding layer, which assists with bonding the occlusal layer to the sub-laver, consists of the reference predicate materials Monobond Plus (K090826) and Multilink Automix (K123397). The Monobond Plus and Multilink Automix materials are used in the subject device for their cleared indications and according to the manufacturer's instructions for use.

The subject device and the primary predicate device K143694 also both incorporate light-cured resin material as a sub-layer to conform to the shape of the prepared tooth, and to provide a customizable, single visit crown restoration. The subject device sub-layer (the crown surface bonded to the prepared tooth) is manufactured from a layer of uncured polymer composite resin to allow for customization and to assist with a cohesive fit of the crown to the prepared tooth. This is the same material used for the same purpose in the primary predicate K143694.

The design of the subject device occlusal layer and the design of the primary predicate device K143694 are essentially the same, except that the subject device has chamfered surfaces (on the apical aspects) and a slightly increased thickness. The chamfered surfaces and slightly increased thickness of the subject device occlusal layer are accommodated by the natural tooth preparation and the thickness of the uncured hybrid ceramic sub-layer. The subject device occlusal layer is made of lithium disilicate, the same intended use as the reference predicate device K100512. Performance testing of the subject device lithium disilicate material also was provided in this submission to support a determination of substantial equivalence.

The L-OVC accessory devices are substantially equivalent in terms of design and function to the predicate K 143694 accessory devices. The designs of the subject device L-OVC Replica are very similar to those of the predicate OVC Replica. The material for the L OVC Replica is different than that of the OVC Replica. To support a determination of substantial equivalence, biocompatibility testing of the L-OVC Replica material was provided in this submission.

CONCLUSION

The subject device and the predicate devices have the same intended use, have similar technological characteristics, and are made of similar materials. The subject device and the primary predicate devices encompass the same range of physical dimensions. The subject device and the predicate devices are packaged in similar materials and are provided nonsterile for single-patient, single-use only.

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.