(142 days)
Not Found
No
The device description focuses on the material composition, physical design, and accessories for manual selection and placement of pre-sized crowns. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI/ML.
No.
This device is a dental crown intended for restoring structurally compromised teeth, which is a restorative rather than a therapeutic function.
No
Explanation: The device is a dental crown intended for restoring permanent teeth. Its accessories aid in fitting and customizing the crown, but none of these functions involve diagnosing a condition; they are solely for restorative purposes.
No
The device description clearly outlines a physical crown made of ceramic and resin, along with several physical accessories (replica, wedges, selector keys). There is no mention of software as the primary component or function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "restoration of permanent teeth with a single unit crown." This is a therapeutic or restorative purpose, not a diagnostic one.
- Device Description: The description details a physical crown and accessories used for fitting and placing the crown on a tooth. It does not describe any components or processes for analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition.
- Performance Studies: The performance studies listed focus on the physical and mechanical properties of the crown material (shelf life, biocompatibility, strength, depth of cure), which are relevant to its function as a dental restoration, not a diagnostic test.
- Lack of Diagnostic Language: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
An In Vitro Diagnostic device is specifically designed to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. The Rhondium One-Visit-Crown does not fit this definition.
N/A
Intended Use / Indications for Use
Rhondium One-Visit-Crown is intended for restoration of permanent teeth with a single unit crown.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
Rhondium One-Visit-Crown (OVC) is a hybrid ceramic crown consisting of a fully-cured anatomical occlusal layer and an uncured sub-layer that allows customization of the OVC to the tooth preparation. When finished, the customized OVC is bonded to a prepared natural tooth. The 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 OVC is selected based on tooth location and size and therefore no impressions are necessary. The OVC is provided in designs for the upper and lower first and second premolars and the first and second molars, and each design is provided in six (6) sizes (extra-small (XS), small (S), medium (M), large (L), extra-large (XL), and extra-extra-large (XXL)). The OVC is made from a ceramic tooth shade resin material, and is provided nonsterile for single use only.
Accessories to the OVC Device include the OVC Replica, an exact replica of the cured (occlusal layer) portion of the OVC. The 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 OVC on the prepared tooth and the relationship with adjacent and opposing dentition. The OVC Replica is manufactured from vinyl polysiloxane impression material. 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 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 single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Permanent teeth, posterior teeth, upper and lower first and second premolars, upper and lower first and second molars.
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)
Performance testing to demonstrate substantial equivalence included methods described in the following standards: ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices; ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process; ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity; and ISO 4049 Dentistry – Polymer-Based Restorative Materials. Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: product shelf life testing, biocompatibility testing, flexural strength testing, static compressive strength testing, and resin depth of cure testing. No clinical data were included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K072733, K050401, K052501, K092319
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2015
Rhondium Ltd. c/o Mr. Kevin A. Thomas PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego California, 92130
Re: K143694
Trade/Device Name: Rhondium One-Visit-Crown (OVC) Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: April 14, 2015 Received: April 15, 2015
Dear Mr. 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.
1
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Tina
Kiang -S
for Erin I. Keith, M.S. 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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Rhondium One-Visit-Crown (OVC)
Indications for Use (Describe)
Rhondium One-Visit-Crown is intended for restoration of permanent teeth with a single unit crown.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ 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 Druq 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
510(k) Summary
Rhondium, Ltd
Rhondium One-Visit-Crown (OVC)
K143694
May 11, 2015
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Rhondium, Ltd
4 Sheffield Street
Katikati, 3129, New Zealand
Telephone: +64 7 549 5566
Fax: +64 7 549 1461 | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Official Contact | Greer Fricker
R&D Projects and Regulatory Manager | |
| Representative/Consultant | Kevin A. Thomas, PhD
Floyd G. Larson
PaxMed International, LLC
12264 El Camino Real, Suite 400
San 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 | Rhondium One-Visit-Crown (OVC) |
|---|---|
| Common Name | Dental material, filling/restorative, polymer based |
| Classification Name | Tooth Shade Resin Material |
| Classification Regulations | 21 CFR 872.3690, Class II |
| Product Code | EBF |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Device Branch |
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510(k) Summary K143694
INTENDED USE
Rhondium One-Visit-Crown is intended for restoration of permanent teeth with a single unit crown.
DEVICE DESCRIPTION
Rhondium One-Visit-Crown (OVC) is a hybrid ceramic crown consisting of a fully-cured anatomical occlusal layer and an uncured sub-layer that allows customization of the OVC to the tooth preparation. When finished, the customized OVC is bonded to a prepared natural tooth. The 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 OVC is selected based on tooth location and size and therefore no impressions are necessary. The OVC is provided in designs for the upper and lower first and second premolars and the first and second molars, and each design is provided in six (6) sizes (extra-small (XS), small (S), medium (M), large (L), extra-large (XL), and extra-extra-large (XXL)). The OVC is made from a ceramic tooth shade resin material, and is provided nonsterile for single use only.
Accessories to the OVC Device include the OVC Replica, an exact replica of the cured (occlusal layer) portion of the OVC. The 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 OVC on the prepared tooth and the relationship with adjacent and opposing dentition. The OVC Replica is manufactured from vinyl polysiloxane impression material. 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 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 single use only.
PERFORMANCE DATA
Performance testing to demonstrate substantial equivalence included methods described in the following standards: ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices; ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process; ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity; and ISO 4049 Dentistry – Polymer-Based Restorative Materials. Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: product shelf life testing, biocompatibility testing, flexural strength testing, static compressive strength testing, and resin depth of cure testing. No clinical data were included in this submission.
5
EQUIVALENCE TO MARKETED DEVICE
Rhondium, Ltd submits the following information in this Premarket Notification to demonstrate, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
K072733, 3M™ ESPE™ Adult Crown, 3M ESPE Dental Products;
K050401, Ceramage, ShoFu Dental Corporation;
K052501, Resin Tooth Bonding Agent, Cosmedent, Incorporated; and
K092319, Star VPS, First Half, First Quarter, Danville Materials, Incorporated.
The primary predicate device is K072733. A comparison of the technological characteristics of the subject device and the predicate device K072733 is provided in the following table.
| Subject Device | Predicate Device | |
|---|---|---|
| Comparison | Rhondium Ltd | |
| One-Visit-Crown (OVC) | ||
| K143694 | 3M ESPE Dental Products | |
| 3M™ ESPE™ Adult Crown | ||
| K072733 | ||
| Crown Description | Preformed single tooth crown for one visit | |
| restoration | Preformed single tooth crown for one visit | |
| restoration | ||
| Teeth to be Restored | Upper and lower premolars and molars | Upper and lower canines, premolars, and molars |
| Specific Crown Designs | N=8 designs : | |
| Upper Premolar, Upper Molar, Lower Premolar, | ||
| Lower Molar | ||
| Each in Left and Right designs | N=5 designs | |
| Canine, Upper Premolar, Upper Molar, Lower | ||
| Premolar; Lower Molar | ||
| Crown Sizes | Each design provided in 6 sizes: | |
| XS, S, M, L, XL, XXL | Each design provided in 2 sizes, except Lower | |
| Premolar (1 size) | ||
| Crown Material | Light-cured polymer composite resin | Light-cured composite |
| Crown Try-in (Trial) | ||
| Material | OVC Replica | |
| Vinyl polysiloxane | None | |
| Sizing Device Material | OVC Selector Key | |
| Polycarbonate | 3M ESPE Crown Size Tool | |
| Material not stated | ||
| Other Accessory | OVC Wedges | |
| polyacetal resin | None |
The subject device and the predicate device K072733 have the same intended use and very similar indications for use (restoration of permanent teeth with a single unit crown). The subject device and the predicate K072733 are provided in a range of designs and sizes to restore the premolars and molars of the upper and lower jaw. The subject device and the predicate K072733 encompass similar ranges of physical dimensions and characteristics, including design and dimensions, and both are made of light-cured resin materials. The subject device and the predicate devices are provided nonsterile for single use only.
6
The subject device consists of a fully-cured layer of tooth shade resin, a bonding layer, and a layer of uncured tooth shade resin to allow for customization and to assist with a cohesive fit of the crown to the prepared tooth.
Any differences in the technological characteristics between the subject device and the predicate devices do not affect substantial equivalence.
CONCLUSION
The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.