(74 days)
No
The device description and performance studies focus on the material properties of a dental composite resin, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a composite resin used for dental restorations, not a therapeutic device. It is a material that repairs or replaces tooth structure, which is a restorative function, not a therapeutic one that treats disease or medical condition.
No
The device is a light-cure composite resin used for dental restorations, direct veneering, splinting, and repair of composite/ceramic restorations. Its purpose is to physically restore and mimic natural tooth appearance, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "light-cure composite resin fabricated from multifunctional acrylic monomers and silicaceous fillers," which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for dental restorations, veneering, splinting, and repair of existing restorations. These are all procedures performed directly on the patient's teeth within the oral cavity.
- Device Description: The device is a light-cure composite resin used as a material for these dental procedures.
- Anatomical Site: The anatomical site is the oral cavity, where the material is applied directly.
- Lack of Diagnostic Purpose: There is no mention of this device being used to diagnose a condition, collect a sample from the body for analysis, or provide information about a patient's health status through testing of biological samples.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a restorative material used in a therapeutic context.
N/A
Intended Use / Indications for Use
Renamel® NANO™ +plus is designed for,
- Class I-V dental restorations
- Direct veneering of anterior teeth
- Splinting
- Repair of composite or ceramic restorations
Product codes
EBF
Device Description
Renamel® NANO™ +plus is a light-cure composite resin fabricated from multifunctional acrylic monomers and silicaceous fillers. These materials possess physical and mechanical properties that allow them to function in the oral cavity with esthetic qualities that mimic natural tooth appearance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
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 mechanical properties, the intended use and the indication for use of Renamel® NANO™ +plus and its predicate: Renamel® NANO™ are the same. The compressive strength, flexural strength, depth of cure, particle size range and radiopacity of both composite materials fall within very similar values. The difference between Renamel® NANO™ and Renamel® NANO™ +plus can be found in chemical (formulation) and handling properties. These properties have a slight impact on the mechanical and physical properties of the composite material.
The data analyzed from the toxicological evaluation of the new added components, and the results of the biocompatibility tests (10993-xx) substantiate that the Renamel® NANO™ +plus is safe and effective as the predicate Renamel® NANO™ (K070583).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Depth of cure (other than opaque materials) ISO 4049:2009; Type1, Class2, Group1: ≥ 1.5mm, Result for Renamel®NANO™+plus: 2.0 mm ± 0.2mm, Result for Renamel®Nano™ (K070583): 2.0 mm ± 0.2mm.
Flexural strength ISO 4049:2009; Type1, Class2, Group1: ≥ 80 MPa, Result for Renamel®NANO™+plus: 127 MPa ± 12 MPa, Result for Renamel®Nano™ (K070583): 125 MPa ± 12 MPa.
Water sorption ISO 4049:2009; Type1, Class2, Group1: ≤ 40 µg/mm³, Result for Renamel®NANO™+plus: 13.5 µg/mm³ ± 0.1 µg/mm³, Result for Renamel®Nano™ (K070583): 21.2 µg/mm³ ± 0.1 µg/mm³.
Solubility ISO 4049:2009; Type1, Class2, Group1: ≤ 7.5 µg/mm³, Result for Renamel®NANO™+plus: 0.0 µg/mm³ ± 0.05 µg/mm³, Result for Renamel®Nano™ (K070583): 0.13 µg/mm³ ± 0.05 µg/mm³.
Radiopacity ISO 4049:2009; Type1, Class2, Group1: ≥ 1mm, Result for Renamel®NANO™+plus: 2.4 mm ± 0.2mm, Result for Renamel®Nano™ (K070583): 2.7 mm ± 0.2mm.
Compressive strength: ≥ 300 MPa, Result for Renamel®NANO™+plus: 360 MPa ± 36 MPa, Result for Renamel®Nano™ (K070583): 367 MPa ± 36 MPa.
Modulus of elasticity: ≥ 7000 MPa, Result for Renamel®NANO™+plus: 10475 MPa ± 1000 MPa, Result for Renamel®Nano™ (K070583): 8925 MPa ± 900 MPa.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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 the department's name encircling a symbol of three stylized human profiles. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The profiles are stacked on top of each other, creating a sense of unity and collaboration.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2017
Cosmedent, Inc Hiren Patel Director Of Regulatory Affairs 401 N Michigan Ave, Suite 2500 Chicago, Illinois 60611
Re: K163480
Trade/Device Name: Renamel Nano +plus Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: November 29, 2016 Received: December 12, 2016
Dear Hiren Patel:
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,
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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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Renamel® NANO™ +plus
Indications for Use (Describe)
Renamel® NANOTM +plus is designed for,
- Class I-V dental restorations
- · Direct veneering of anterior teeth
- · Splinting
- · Repair of composite or ceramic restorations
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)
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| Section 5: 510(k) Summary | |||
|---|---|---|---|
| -- | -- | -- | --------------------------- |
| Date Prepared: | 12/21/2016 |
|---|---|
| Company Name: | Cosmedent, Inc |
| 401 N Michigan Ave, | |
| Suite 2500, | |
| Chicago, IL, 60611 | |
| Tel: 312-644-9586, Fax: 312-644-9752 | |
| Contact Person: | Hiren Patel |
| Director of Regulatory Affairs | |
| Cosmedent, Inc | |
| Tel: 312-644-9586 | |
| Email: hiren@cosmedent.com | |
| Trade name: | Renamel® NANO™ +plus (NANO COMPOSITE) |
| Common Name: | Nano-Hybrid Dental Composite |
| Regulatory Class: | Class II |
| Device Panel: | Dental Panel |
| Regulation Number: | 21 CFR 872.3690 |
| Classification Name: | Tooth Shade Resin Material |
| Product Code: | EBF |
Substantially Equivalent to:
The Renamel® NANO™ +plus is substantially equivalent to the Renamel® NANO™ (Cosmedent, Inc. K070583) cleared by FDA on April 16 2007.
Device Description:
Renamel® NANO™ +plus is a light-cure composite resin fabricated from multifunctional acrylic monomers and silicaceous fillers. These materials possess physical and mechanical properties that allow them to function in the oral cavity with esthetic qualities that mimic natural tooth appearance.
Intended Use/Indication for Use:
Renamel® NANO™ +plus is designed for,
- Class I-V dental restorations ●
- Direct veneering of anterior teeth
- Splinting
- Repair of composite or ceramic restorations ●
Substantial Equivalence Summary
The mechanical properties, the intended use and the indication for use of Renamel® NANO™ +plus and its predicate: Renamel® NANO™ are the same. The compressive strength, flexural strength, depth of cure, particle size range and radiopacity of both composite materials fall within
4
very similar values. The difference between Renamel® NANO™ and Renamel® NANO™ +plus can be found in chemical (formulation) and handling properties. These properties have a slight impact on the mechanical and physical properties of the composite material.
| Property / Standard | Specification | Renamel®NANO™+plus | Renamel®Nano™
(K070583) |
|-------------------------------------------------------------------------------------------|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Application properties/
delivery form | --- | Preloaded, plastic-screw fed syringe (5 grams),
and individual unit dose compules (0.25 gram).
The material is extruded directly (without tip)
onto a suitable pad and placed in the prepared
cavity and light cured. | |
| Light curing wavelength | --- | LED and Halogen light at wavelength range of
400 - 500 nm. | |
| Depth of cure (other than
opaque materials)
ISO 4049:2009; Type1,
Class2, Group1 | ≥ 1.5mm | 2.0 mm
± 0.2mm | 2.0 mm
± 0.2mm |
| Flexural strength
ISO 4049:2009; Type1,
Class2, Group1 | ≥ 80 MPa | 127 MPa
± 12 MPa | 125 MPa
± 12 MPa |
| Water sorption
ISO 4049:2009; Type1,
Class2, Group1 | ≤ 40 µg/mm³ | 13.5 µg/mm³
± 0.1 µg/mm³ | 21.2 µg/mm³
± 0.1 µg/mm³ |
| Solubility
ISO 4049:2009; Type1,
Class2, Group1 | ≤ 7.5 µg/mm³ | 0.0 µg/mm³
± 0.05 µg/mm³ | 0.13 µg/mm³
± 0.05 µg/mm³ |
| Radiopacity
ISO 4049:2009; Type1,
Class2, Group1 | ≥ 1mm | 2.4 mm
± 0.2mm | 2.7 mm
± 0.2mm |
| Compressive strength | ≥ 300 MPa | 360 MPa
± 36 MPa | 367 MPa
± 36 MPa |
| Modulus of elasticity | ≥ 7000 MPa | 10475 MPa
± 1000 MPa | 8925 MPa
± 900 MPa |
Table 5.1: Comparison of Renamel® NANO™ +plus / Renamel® NANO™ (K070583)
Substantial equivalent in Safety and efficacy (Biocompatibility)
The data analyzed from the toxicological evaluation of the new added components, and the results of the biocompatibility tests (10993-xx) substantiate that the Renamel® NANO™ +plus is safe and effective as the predicate Renamel® NANO™ (K070583).
Results/summary of the Substantial Equivalence
The subject device Renamel® NANO™ +plus has been compared with its predicate Renamel® NANO™ with regard to indication (intended use), performance data and chemical composition. In order to obtain better handling properties (stiffness and sculptability), the composition of the device has been modified. None of the new ingredients in the subject device poses any new concerns of safety and effectiveness, and comparison shows, that Renamel®NANO™+plus is substantially equivalent to the predicate Renamel®NANO™ (K070583).