(1 days)
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No
The device description focuses on the material composition and physical properties of a dental composite, with no mention of software, algorithms, or AI/ML capabilities.
No.
A therapeutic device is one that treats or heals a disease or condition. This device is a restorative composite used for filling cavities in teeth, which is a structural repair rather than a therapeutic treatment.
No
The device is a restorative composite material used for fillings in teeth, not for diagnosing medical conditions.
No
The device description clearly indicates that FORMA™ Composite is a physical material (Bis-GMA-based restorative composite) used for dental restorations, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "restorations in anterior and posterior teeth" and "direct and indirect restorations in both the anterior and posterior regions." This describes a material used in the body for structural repair, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details the composition and properties of a dental filling material (composite). It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
This device is clearly a dental restorative material, which is a type of medical device used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
FORMA Composite is designed for restorations in anterior and posterior teeth.
FORMA™ Composite is used for direct and indirect restorations in both the anterior and posterior regions.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
FORMA™ Composite is a Bis-GMA-based restorative composite. FORMA™ composite is designed for restorations in anterior and posterior teeth and is suitable for occlusal surfaces. Its formula contains a zirconia/silica inorganic filler combination and barium glass. FORMA™ composite is shaded based on the VITA shade guide, and is radiopaque. FORMA™ composite has a radiopacity value greater than 2 mm of aluminum has a radiopacity equivalent to that of dentin. Thus, 1 mm of material having a radiopacity equivalent to 1 mm of aluminum has a radiopacity equivalent to that of dentin and 2 mm of aluminum is equivalent to enamel.
FORMA™ composite A3D is filled 78% w/w. FORMA™ composite is a nanohybrid composite with nanoparticles entombed within the composite's formulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentist or dental 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)
Verification and validation testing was performed to show that the subject device is substantially equivalent to the currently marketed predicate device, Mosaic Universal Composite. Full testing to ISO 4049:2019, surface hardness evaluation, drop test ship testing, and an assessment on the curing wavelength, curing intensity and curing time were completed for the product verification testing.
Simulated use and validation testing was conducted by dental professionals to confirm that all aspects from usability assessments and risk management were implemented in the labeling and the design of the device itself. The conclusion of this validation testing confirmed that the subject device met the predefined user needs and the indications for use, which are identical to the predicate device. Thus the verification and validation support the conclusion that the subject device, FORMA Composite, is substantially equivalent to the predicate device, Mosaic Universal Composite (K151094).
FORMA Composite has been evaluated for applicable biological risks associated to the device type according to ISO 7405:2018 and ISO 10993-1:2018. Cytotoxicity, Sensitization, and Irritation tests were conducted according to applicable ISO 10993 series standards. Other applicable biological endpoints (Systemic Toxicity, Implantation Effects, and Genotoxicity) were evaluated utilizing available literature, chemical characterization testing and other biocompatibility tests available for the device and its constituents.
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.
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.
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March 15, 2024
Ultradent Products, Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K240694
Trade/Device Name: FORMA Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: Class II Product Code: EBF Dated: March 12, 2024 Received: March 14, 2024
Dear Dave Yungvirt:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K240694
Device Name FORMA Composite
| Indications for Use (Describe) | FORMA Composite is designed for restorations in anterior and posterior teeth. |
|---|---|
| -------------------------------- | ------------------------------------------------------------------------------- |
Type of Use (Select one or both, as applicable)
| Remediation Use (Part 21 CFR 221, Subpart D) |
|---|
| Cosmetic Use (21 CFR 221, Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Ultradent Products, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 Est. Reg. No. 1718912
510(k) Summary
This summary of the 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92 FORMA Composite.
I. Applicant's Name and Address
Ultradent Product, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095
| Contact Person: | Adam Black |
|---|---|
| Title: | Senior Manager - Regulatory Affairs |
| Telephone: | 801-553-4425 |
| Email: | adam.black@ultradent.com |
| Date Summary Prepared: | March 11, 2024 |
II. Name of the Device
| Device: | FORMA Composite |
|---|---|
| Trade/Device Name: | FORMA Composite (Shade A3D) |
| Common Name: | Tooth Shade, Resin |
| Review Panel: | Dental |
| Regulation Number: | 21 CFR 872.3690 |
| Device Class: | Class II |
| Product Code(s): | EBF |
III. Device Description
FORMA™ Composite is a Bis-GMA-based restorative composite. FORMA™ composite is designed for restorations in anterior and posterior teeth and is suitable for occlusal surfaces. Its formula contains a zirconia/silica inorganic filler combination and barium glass. FORMA™ composite is shaded based on the VITA shade guide, and is radiopaque. FORMA™ composite has a radiopacity value greater than 2 mm of aluminum has a radiopacity equivalent to that of dentin. Thus, 1 mm of material having a radiopacity equivalent to 1 mm of aluminum has a radiopacity equivalent to that of dentin and 2 mm of aluminum is equivalent to enamel.
FORMA™ composite A3D is filled 78% w/w. FORMA™ composite is a nanohybrid composite with nanoparticles entombed within the composite's formulation.
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Ultradent Products, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 Est. Reg. No. 1718912
IV. Statement of Intended Use
FORMA™ Composite is used for direct and indirect restorations in both the anterior and posterior regions.
V. Predicate Device
Predicate Identified: Mosaic Universal Composite K151094
VII. Comparison of Technological Characteristics
Predicate technological comparison:
The predicate and subject device have the same technological characteristics, which is primarily the design as a light-curable dental composite material which is available in a reusable syringe and single-use capsule presentation. The primary difference between the subject and predicate device is in the chemical composition which was adjusted for handling and shading. These differences and similarities have been evaluated below in Table 1:
Table 1
| Descriptive
Information | Subject Device: FORMA Composite | Predicate: Mosaic Universal
Composite (K151094) | Explanation of
Differences |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | EBF | EBF | N/A – Identical product
code |
| Indications for
Use | FORMA™ Composite is used for
direct and indirect restorations in
both the anterior and posterior
regions. | Mosaic composite is used for direct
and indirect restorations (inlays,
onlays, and veneers) in both the
anterior and posterior regions. | The removal of the
examples of indirect
restoration types "inlays,
onlays, and veneers" does
not impact the safety or
performance as this
information was only to
provide small
clarification. |
| Principle of
Operation | Mechanical leverage is used to
express composite. The unique
chemical structure of FORMA | Mechanical leverage is used to
express composite. The unique
chemical structure of Mosaic allows | N/A – Identical principles
of operation |
| Descriptive
Information | Subject Device: FORMA Composite | Predicate: Mosaic Universal
Composite (K151094) | Explanation of
Differences |
| | Composite allows for the chemistry
to be placed into preformed
cavities in the tooth structure to
rebuild the physical structure of the
removed dentin. The formulation
contains photoinitiators that cause
polymerization of the moldable
chemistry. Once the device is
polymerized, it exhibits mechanical
and physical behaviors similar to
that of natural dentition. | for the chemistry to be placed into
preformed cavities in the tooth
structure to rebuild the physical
structure of the removed dentin. The
formulation contains photoinitiators
that cause polymerization of the
moldable chemistry. Once the device
is polymerized, it exhibits
mechanical and physical behaviors
similar to that of natural dentition. | |
| Intended User | Dentist or dental professional | Dentist or dental professional | N/A – Identical Intended
User |
| Delivery System | 4g Reusable Syringe or 0.2g single-
use capsule | 4g Reusable Syringe or 0.2g single-
use capsule | N/A – Identical delivery
system offerings |
| Composition of
Materials | Bis-GMA, TEGDMA, Bis-EMA, and
UDMA base
Photoinitiators (Camphorquinone)
Silanated Glass
Silica | Bis-GMA, TEGDMA, UDMA base
Photoinitiators (Camphorquinone)
Silanated Glass
Silica | Similar – Base material
has been adjusted for
handling and to achieve
proper shade. |
| Physical
Properties | Depth of Cure ≥1.5mmCurable wavelength 385-
515nmCuring Intensity ≥800 mW/cm²Curing Time 10s per layer, 20s
final cureFlexural Strength ≥80 MPaFiller particle size 0.014-3µmWater sorption ≤40 µg/mm³Water solubility ≤7.5 µg/mm³Radio-Opacity ≥1mm of AlSurface Hardness ≥50.0 HK | Depth of Cure ≥1.5mmCurable wavelength 385-515nmCuring Intensity ≥800 mW/cm²Curing Time 10s per layer, 20s
final cureFlexural Strength ≥80 MPaFiller particle size* ≥0.02µmWater sorption ≤40 µg/mm³Water solubility ≤7.5 µg/mm³Radio-Opacity ≥1mm of AlSurface Hardness ≥50.0 HK | Similar – ISO 4049
Compliant |
| FDA Recognized
Standards | ISO 7405: 2018
ISO 4049:2019
IEC 62366-1:2020
ISO 14971:2019
ISO 10993-1:2018
ISO 15223-1:2021
ISO 7491-2000 | ISO 7405: 2018
ISO 4049:2009
IEC 62366-1:2015
ISO 14971:2012
ISO 10993-1:2018
ISO 7491:2000 | Similar – Addition of ISO
15223-1 based on use of
symbols |
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Image /page/5/Picture/1 description: The image shows the address and contact information for Ultradent Products, Inc. The address is 505 West Ultradent Drive (10200 South), South Jordan, UT 84095. The establishment registration number is 1718912. The image also includes the Ultradent logo.
6
Image /page/6/Picture/1 description: The image shows the Ultradent Products, Inc. logo and company information. The logo is an orange square with the letters "UP" in white. Below the logo is the word "ULTRADENT" in white. The company address is listed as "lent Drive (10200 South) South Jordan, UT 84095".
505 West Ultradent Drive (10200 South) South Jordan, UT 84095 Est. Reg. No. 1718912
VIII Non-Clinical Performance Testing:
Verification and validation testing was performed to show that the subject device is substantially equivalent to the currently marketed predicate device, Mosaic Universal Composite. Full testing to ISO 4049:2019, surface hardness evaluation, drop test ship testing, and an assessment on the curing wavelength, curing intensity and curing time were completed for the product verification testing.
Simulated use and validation testing was conducted by dental professionals to confirm that all aspects from usability assessments and risk management were implemented in the labeling and the design of the device itself. The conclusion of this validation testing confirmed that the subject device met the predefined user needs and the indications for use, which are identical to the predicate device. Thus the verification and validation support the conclusion that the subject device, FORMA Composite, is substantially equivalent to the predicate device, Mosaic Universal Composite (K151094).
IX Biocompatibility Assessment
FORMA Composite has been evaluated for applicable biological risks associated to the device type according to ISO 7405:2018 and ISO 10993-1:2018. Cytotoxicity, Sensitization, and Irritation tests were conducted according to applicable ISO 10993 series standards. Other applicable biological endpoints (Systemic Toxicity, Implantation Effects, and Genotoxicity) were evaluated utilizing available literature, chemical characterization testing and other biocompatibility tests available for the device and its constituents.
Conclusion:
The predicate and subject devices have identical indications for use with a slight variation to remove the examples of indirect restoration types. The differences between the predicate and subject device have been evaluated with established methods, including testing to ISO 4049, biological risk evaluations according to ISO 10993-1, and product packaging assessments. Based on the testing and evaluation of the subject device, FORMA Composite, as compared to the predicate device, Mosaic Universal Composite (K151094), the conclusion can be made that FORMA Composite is substantially equivalent to the predicate device.