L- OVC

K162677 · Rhondium, Ltd. · EIH · Dec 21, 2016 · Dental

Device Facts

• Record ID: K162677
• Device Name: L- OVC
• Applicant: Rhondium, Ltd.
• Product Code: EIH · Dental
• Decision Date: Dec 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

L-OVC is a preformed ceramic crown system for single-visit restoration of posterior teeth; consists of lithium disilicate occlusal layer and uncured hybrid ceramic sub-layer; clinician selects size based on tooth location/dimensions; no impressions required; sub-layer allows customization to tooth preparation; bonded to natural tooth; accessories include replica for clearance verification, wedges for interproximal spacing, and selector keys for sizing; used in dental clinic by dentists; provides anatomic occlusal surface; benefits include reduced chair time and simplified restoration process.

Clinical Evidence

No clinical data were included in this submission. Bench testing included biocompatibility (ISO 10993 series), ceramic flexural strength, solubility, and radioactivity (ISO 6872), and shelf life (ASTM F1980).

Technological Characteristics

Materials: lithium disilicate ceramic, hybrid ceramic composite resin, thermoplastic elastomer (replica), polyacetal (wedges), polycarbonate (keys). Form factor: preformed anatomic occlusal layers in 8 designs and 5 sizes. Nonsterile, single-use. No electronic components or software.

Indications for Use

Indicated for restoration of permanent teeth with a single unit crown in patients requiring onlay or partial crown restoration of structurally compromised posterior teeth.

Regulatory Classification

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.

Predicate Devices

• Rhondium One-Visit-Crown (OVC) (K143694)

Reference Devices

• NobelProcera IPS e.max Crown (K100512)
• Monobond Plus (K090826)
• Multilink Automix (K123397)

Submission Summary (Full Text)

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

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

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

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 [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.

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

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

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.

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."

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

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

# 510(k) Summary Rhondium, Ltd L-OVC

December 15, 2016

#### ADMINISTRATIVE INFORMATION

| Manufacturer Name | Rhondium, Ltd<br>4 Sheffield Street<br>Katikati, 3129, New Zealand | | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|--|
| | Telephone: | [phone] | |
| | Fax: | [phone] | |
| Official Contact | Greer Fricker<br>Regulatory Manager | | |
| Representative/Consultant | Kevin A. Thomas, PhD<br>Floyd G. Larson, MS, MBA<br>PaxMed International, LLC<br>12264 El Camino Real, Suite 400<br>San Diego, CA 92130 | | |
| | Telephone: | [phone] | |
| | Fax: | [phone] | |
| | Email: | [e-mail]<br>[e-mail] | |

#### 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

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

#### INDICATIONS FOR USE

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

#### DEVICE DESCRIPTION

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.

## 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.

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

| | | | Comparison of Subject Device and Predicate Device Characteristics | |
|--|--|--|-------------------------------------------------------------------|--|
| | | | | |

| | Subject Device | Primary Predicate Device | Reference Predicate Devices | | |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison | L-OVC<br>Rhondium Ltd | K143694<br>One-Visit-Crown (OVC)<br>Rhondium Ltd | K100512<br>NobelProcera IPS e.max<br>Crown<br>Nobel Biocare AB | K090826<br>Monobond Plus<br>Ivoclar Vivadent, Inc. | K123397<br>Multilink Automix<br>Ivoclar Vivadent, AG |
| Indications for<br>Use | L-OVC is intended for<br>restoration of permanent teeth<br>with a single unit crown. | Rhondium One-Visit-Crown<br>is intended for restoration of<br>permanent teeth with a single<br>unit crown. | The NobelProcera IPS e.max<br>Crown is indicated for use as<br>core structures of crowns that<br>will be cemented to natural or<br>artificial tooth abutments in<br>the treatment of partially<br>edentulous patients as an aid<br>in prosthetic rehabilitation. | Monobond Plus serves as<br>bonding agent and is used to<br>create a durable chemical<br>bond between luting<br>composites and glass/oxide<br>ceramic, metal, composite and<br>fiber-reinforced composite<br>restorations. | Multilink Automix is used for<br>the permanent cementation of<br>indirect restorations where a<br>strong bond is desired: inlays,<br>onlays, crowns, bridges and<br>root posts made of:<br>• Metal and metal ceramics<br>• All-ceramics, in particular<br>opaque zirconium oxide<br>ceramics<br>• Composites and fibre-<br>reinforced composites |
| Description | Preformed single tooth crown<br>for one visit restoration | Preformed single tooth crown<br>for one visit restoration | Lithium disilicate ceramic<br>intended for the fabrication of<br>crowns | Primer to promote adhesive<br>bonding between luting<br>composites and indirect<br>restorative materials (glass<br>and oxide ceramics, metal,<br>composites, fiber-reinforced<br>composites) | Self-curing luting composite<br>with light-curing option for<br>adhesive luting of indirect<br>restorations made of metal,<br>metal-ceramic, all-ceramic<br>and composite |
| Teeth to be<br>Restored | Upper and lower premolars<br>and molars | Upper and lower premolars<br>and molars | n/a | n/a | n/a |
| Specific Crown<br>Designs | N=8<br>Upper Premolar, Upper Molar<br>Lower Premolar, Lower<br>Molar<br>Each in Left and Right<br>designs | N=8<br>Upper Premolar, Upper Molar<br>Lower Premolar, Lower<br>Molar<br>Each in Left and Right<br>designs | n/a | n/a | n/a |
| Crown Sizes | Each design in 5 sizes:<br>XS, S, M, L, XL | Each design in 6 sizes:<br>XS, S, M, L, XL, XXL | n/a | n/a | n/a |
| Materials | Crown occlusal layer:<br>lithium disilicate ceramic<br>Primer/assist bonding:<br>Monobond Plus (K090826)<br>Multilink Automix (K123397)<br>Sub-layer bonded to prepared<br>tooth:<br>Light-cured polymer<br>composite resin | Crown occlusal layer:<br>Light-cured polymer<br>composite resin (Ceramage,<br>K050401)<br>Primer/assist bonding:<br>Complete Unfilled Resin<br>(K052501)<br>Sub-layer bonded to prepared<br>tooth:<br>Light-cured polymer<br>composite resin | Lithium disilicate ceramic | Silane methacrylate,<br>phosphoric acid methacrylate,<br>and sulfide methacrylate | Monomer matrix (60%):<br>dimethacrylate and HEMA<br>(2-hydroxyethyl methacrylate)<br>Inorganic fillers (40%):<br>barium glass, ytterbium<br>trifluoride, spheroid mixed<br>oxide |
| Crown<br>Provisional<br>(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.

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

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.