(88 days)
Not Found
No
The device description and performance studies focus on the material properties and biocompatibility of a dental restorative material, with no mention of AI or ML technology.
No
The device is a dental restorative material used to create lifelike dental restorations, fill cavities, and repair veneers. It does not actively treat or cure a disease or condition, but rather restores function and aesthetics.
No
Explanation: The device description states that Renamel® Microfill is a "dental restorative material" used to "create lifelike dental restoration." Its indications for use include filling cavities and repairing teeth, which are restorative, not diagnostic, functions.
No
The device description clearly states it is a "light-cured, microfilled, highly polishable dental restorative material" consisting of "multi-functional acrylic Resin and fillers". This describes a physical material, 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 to "create lifelike dental restoration." This is a therapeutic and restorative purpose, not a diagnostic one.
- Indications for Use: The indications are for various types of dental restorations (veneers, fillings, closing gaps, repairs). These are all clinical procedures performed directly on the patient's teeth.
- Device Description: The description details a "light-cured, microfilled, highly polishable dental restorative material." This is a material used to physically repair or replace tooth structure.
- Anatomical Site: The anatomical site is the "Oral cavity," where the material is applied directly to the patient's teeth.
- IVD Definition: An In Vitro Diagnostic device is used to examine specimens derived from the human body (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening.
Renamel® Microfill is a material used in vivo (within the living body) for direct dental restoration, not for testing samples in vitro (outside the living body) for diagnostic purposes.
N/A
Intended Use / Indications for Use
Renamel® Microfill is intended to be used to create lifelike dental restoration.
Renamel® Microfill is designed for,
- Direct anterior veneers
- Anterior Class III and IV restorations
- Class V restorations (cervical caries, root erosion, wedge-shaped defects)
- Closing of diastemas
- Repair of composite and ceramic veneers
- Top layer of Class I and II restorations
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
Renamel® Microfill is light-cured, microfilled, highly polishable dental restorative material. According to the applicable FDA recognized consensus standard ISO 4049 - "Dentistry -Polymer-based restorative materials", this device is classified as Type 1, Class 2, Group 1: Polymer-based restorative materials, involving occlusal surfaces, which uses external energy source for intra-orally curing. Renamel® Microfill consists of multi-functional acrylic Resin and fillers of 0.04 - 0.2 micron sized particles of inorganic and prepolymerized composite (70% by weight, 60% by volume). These devices possess physical and mechanical properties that allow them to function in the oral cavity with esthetic quality that mimics natural enamel surface.
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
healthcare professional
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)
Comparison of physical and mechanical properties:
- Depth of cure (ISO 4049:2009; Type1, Class2, Group1): Renamel® Microfill: 2.15 mm ± 0.1mm, Renamel® Composite Resin (K854755): 2.0 mm ± 0.1mm
- Flexural strength (ISO 4049:2009; Type1, Class2, Group1): Renamel® Microfill: 95.5 MPa ± 3 MPa, Renamel® Composite Resin (K854755): 76 MPa ± 4 MPa
- Water sorption (ISO 4049:2009; Type1, Class2, Group1): Renamel® Microfill: 15 µg/mm³ ± 0.5 µg/mm³, Renamel® Composite Resin (K854755): 12.5 µg/mm³ ± 0.5 µg/mm³
- Solubility (ISO 4049:2009; Type1, Class2, Group1): Renamel® Microfill: 0.9 µg/mm³, Renamel® Composite Resin (K854755): 1.1 µg/mm³
- Radiopacity (ISO 4049:2009; Type1, Class2, Group1): Renamel® Microfill: None (not claimed), Renamel® Composite Resin (K854755): None (not claimed)
- Compressive strength: Renamel® Microfill: 410 MPa ± 40 MPa, Renamel® Composite Resin (K854755): 390 MPa ± 30 MPa
- Modulus of elasticity: Renamel® Microfill: 5100 MPa ± 300 MPa, Renamel® Composite Resin (K854755): 4575 MPa ± 440 MPa
Biocompatibility studies were performed on the subject Renamel® Microfill. The data were analyzed and the results of the biocompatibility tests (ISO10993-1, ISO10993-2, ISO10993-5, ISO10993-10, & ISO10993-11) substantiate that Renamel® Microfill with its modification in composition is as safe (biocompatible) as the predicate Renamel® Composite Resin.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Depth of cure (ISO 4049:2009; Type1, Class2, Group1): ≥ 1.5mm
Flexural strength (ISO 4049:2009; Type1, Class2, Group1): ≥ 80 MPa
Water sorption (ISO 4049:2009; Type1, Class2, Group1): ≤ 40 µg/mm³
Solubility (ISO 4049:2009; Type1, Class2, Group1): ≤ 7.5 µg/mm³
Radiopacity (ISO 4049:2009; Type1, Class2, Group1): ≥ 1mm
Compressive strength: ≥ 320 MPa
Modulus of elasticity: ≥ 3000 MPa
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.
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
December 5, 2017
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Cosmedent, Inc Mary Nowak Vice President Development & Regulatory Affairs 401 N. Michigan Ave, Suite 2500 Chicago, Illinois 60611
Re: K172707
Trade/Device Name: Renamel® Microfill Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: September 5, 2017 Received: September 8, 2017
Dear Mary Nowak:
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 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);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the name "Mary S. Runner -S" in a simple, sans-serif font. The text is black against a white background. The letters are evenly spaced and easily readable.
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) K172707
Device Name Renamel® Microfill
Indications for Use (Describe)
Renamel® Microfill is designed for,
- · Direct anterior veneers
- · Anterior Class III and IV restorations
- · Class V restorations (cervical caries, root erosion, wedge-shaped defects)
- · Closing of diastemas
- · Repair of composite and ceramic veneers
- Top layer of Class I and II restorations
| Type of Use (Select one or both, as applicable) |
|---|
| Residential Use (Part 1, CFR 201.2, Subpart B) |
| Care-Type Supportive Use (24 CFR 201.2, Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Section 5: 510(k) Summary K172707
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92
| Date Prepared: | 12/01/2017 |
|---|---|
| 501(k) Submitter: | Cosmedent, Inc. |
| 401 N Michigan Ave, | |
| Suite 2500, | |
| Chicago, IL, 60611 | |
| Tel: 312-644-9586, Fax: 312-644-9752 | |
| Contact Person: | Gary Chuven |
| Director of Regulatory Affairs | |
| Cosmedent, Inc. | |
| Tel: 312-644-9395 ext. 117 | |
| Email: gary@cosmedent.com | |
| Trade Name: | Renamel® Microfill (Composite) |
| Common Name: | Light-Cured Dental Restorative Composite |
| Regulatory Class: | Class II |
| Device Panel: | Dental Panel |
| Regulation Number: | 21 CFR 872.3690 |
| Classification Name: | Tooth Shade Resin Material |
| Product Code: | EBF |
Description of Device:
Renamel® Microfill is light-cured, microfilled, highly polishable dental restorative material. According to the applicable FDA recognized consensus standard ISO 4049 - "Dentistry -Polymer-based restorative materials", this device is classified as Type 1, Class 2, Group 1: Polymer-based restorative materials, involving occlusal surfaces, which uses external energy source for intra-orally curing. Renamel® Microfill consists of multi-functional acrylic Resin and fillers of 0.04 - 0.2 micron sized particles of inorganic and prepolymerized composite (70% by weight, 60% by volume). These devices possess physical and mechanical properties that allow them to function in the oral cavity with esthetic quality that mimics natural enamel surface.
Intended Use:
Renamel® Microfill is intended to be used to create lifelike dental restoration.
Indications for Use:
Renamel® Microfill is designed for,
- Direct anterior veneers
- Top layer of Class I and II restorations
4
- Anterior Class III and IV restorations ●
- Class V restorations (cervical caries, root erosion, wedge-shaped defects)
- Closing of diastemas
- Repair of composite and ceramic veneers
Substantial Equivalence Discussion:
Intended Use/ Indication for Use
Subject Renamel® Microfill lists the specific indication for use to provide better understanding to the healthcare professional. The original statement in PMN K854755 was considered insufficiently specific. Specifying the indications for use does not add any new safety and effectiveness concerns. Also, it does not change the intended use, "to create lifelike dental restorations."
Chemical Composition
Chemical composition of the subject Renamel® Microfill and predicate Renamel® Composite Resin is somewhat different. The changes in the chemical composition are to comply with the requirements of the ISO 4049 Type 1 Class 2 Group 1 standards with similar handling and polishing properties. The predicate device does not achieve the necessary flexural strength values for Type 1 restorative materials. In addition, subject Renamel® Microfill has more shades for dental restoration and a new single use package (Compule). Neither the changes in the chemical composition nor the new single use package of the subjected Renamel® Microfill add any new concerns of safety.
The table below depicts the modification associated with Renamel® Microfill and Renamel® Composite Resin (K854755).
| Property / Standard | Specification | Renamel® Microfill | Renamel® Composite
Resin (K854755) |
|------------------------------------------|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Application properties/
delivery form | --- | Preloaded, plastic-screw
fed syringe (4 grams),
and individual unit dose
compules (0.20 gram).
The material is extruded
directly (without tip) onto
a suitable pad and placed
in the prepared cavity and
light cured. | Preloaded, plastic-
screw fed syringe (2.5
grams). The material is
extruded directly
(without tip) onto a
suitable pad and placed
in the prepared cavity
and light cured. |
| Intended use | --- | Intended to be used to
create lifelike dental
restoration. | Intended to be used to
create lifelike dental
restoration. |
| Indication for Use | --- | Renamel® Microfill is
designed for,
Direct anterior veneers Top layer of Class I and II restorations Anterior Class III and IV restorations Class V restorations
(cervical caries, root
erosion, wedge- | --- |
Table 5.1: Predicate Renamel® Resin Composite and Proposed Renamel® Microfill
5
| Property / Standard | Specification | Renamel® Microfill | Renamel® Composite
Resin (K854755) |
|----------------------------------------------------------------------------------|---------------|------------------------------------------------------------------------------|---------------------------------------|
| | | shaped defects) Closing of diastemas Repair of composite and ceramic veneers | |
| 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 | 2.15 mm
± 0.1mm | 2.0 mm
± 0.1mm |
| Flexural strength ISO 4049:2009; Type1, Class2, Group1 | ≥ 80 MPa | 95.5 MPa
± 3 MPa | 76 MPa
± 4 MPa |
| Water sorption ISO 4049:2009; Type1, Class2, Group1 | ≤ 40 µg/mm³ | 15 µg/mm³
± 0.5 µg/mm³ | 12.5 µg/mm³
± 0.5 µg/mm³ |
| Solubility ISO 4049:2009; Type1, Class2, Group1 | ≤ 7.5 µg/mm³ | 0.9 µg/mm³ | 1.1 µg/mm³ |
| Radiopacity ISO 4049:2009; Type1, Class2, Group1 | ≥ 1mm | None
(not claimed) | None
(not claimed) |
| Compressive strength | ≥ 320 MPa | 410 MPa
± 40 MPa | 390 MPa
± 30 MPa |
| Modulus of elasticity | ≥ 3000 MPa | 5100 MPa
± 300 MPa | 4575 MPa
± 440 MPa |
Substantial equivalent in Safety (Biocompatibility)
Biocompatibility studies were performed on the subject Renamel® Microfill. The data were analyzed and the results of the biocompatibility tests (ISO10993-1, ISO10993-2, ISO10993-5, ISO10993-10, & ISO10993-11) substantiate that Renamel® Microfill with its modification in composition is as safe (biocompatible) as the predicate Renamel® Composite Resin.
Conclusion:
The subject device Renamel® Microfill has been compared with its predicate Renamel® Composite Resin with regards to intended use, performance data and chemical composition. In order to provide compliance with ISO 4049 Type 1 Class 2 (Class I&II restorations), the composition of the device has been modified. None of the new ingredients (pigments, polyacrylic resin) in the subject device poses any new concerns of safety and effectiveness, and comparison shows, that Renamel® Microfill is substantially equivalents to the predicate Renamel® Composite Resin (K854755).