(243 days)
No
The description focuses on the material properties and intended use of a dental composite resin, with no mention of AI or ML capabilities.
No
This device is a dental restorative material (composite resin) used for direct anterior and posterior restorations, which is generally not classified as a therapeutic device. Therapeutic devices typically involve treating a disease, injury, or other condition, rather than simply restoring a part of the body.
No
Explanation: The device is described as a restorative material (tooth shade resin) used for direct anterior and posterior restorations, cavity base or liner, and repair of porcelain/composite. Its function is to fill and repair, not to diagnose conditions.
No
The device description clearly states it is a "paste that comes in a plastic syringe" and is a "low viscosity, light-cured, radiopaque composite resin," indicating it is a physical material, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states the device is a "tooth shade resin material" used for "direct anterior and posterior restorations, cavity base or liner, and repair of porcelain/ composite." This is a material applied directly to the teeth for restorative purposes.
- Lack of Biological Sample Testing: There is no mention of the device being used to test or analyze any biological samples from a patient. Its function is to fill and repair dental structures.
Therefore, the OMNICHROMA FLOW device falls under the category of a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is indicated for use for direct anterior and posterior restorations, cavity base or liner, and repair of porcelain/composite.
Product codes
EBF
Device Description
The OMNICHROMA FLOW tooth shade resin material is a paste that comes in a plastic syringe (1.8mL). The device is a low viscosity, light-cured, radiopaque composite resin for use in anterior and posterior restorations for all carious classes. OMNICHROMA FLOW is a single shade material. Direct placement of OMNICHROMA FLOW into a prepared cavity allows for easy handling.
OMNICHROMA FLOW is designed to be cured by either a halogen or LED curing-light with a wavelength of 400-500 nm. Be sure to light-cure OMNICHROMA FLOW extra-orally and check the time needed for complete hardening of OMNICHROMA FLOW with your lightcuring unit before performing the bonding procedure.
The device is intended for use by licensed healthcare professionals only. The device does not come sterilized and is not intended to be sterilized prior to use.
The OMNICHROMA FLOW device contains methacrylic monomers and a UV absorber. The device should not be used on patients who are allergic to or hypersensitive to methacrylic and related monomers, UV absorber, or any of the other ingredients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed healthcare professionals
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)
Non-clinical testing of the physical properties of the OMNICHROMA FLOW device was conducted in accordance with ISO 4049:2009, "Dentistry -- Polymer-based Restorative Materials." There were no clinical tests performed for the OMNICHROMA FLOW device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is in blue.
August 19, 2020
Tokuyama Dental Corporation % Keith Barritt Official Correspondent Fish & Richardson P.C. 1000 Maine Avenue, S.W. Suite 1000 Washington, District of Columbia 20024
Re: K193537
Trade/Device Name: Omnichroma Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: Mav 21, 2020 Received: May 22, 2020
Dear Keith Barritt:
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.
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
1
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 (OS) 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,
For Srinivas "Nandu" Nandkumar Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193537
Device Name OMNICHROMA FLOW
Indications for Use (Describe)
The device is indicated for use for direct anterior and posterior restorations, cavity base or liner, and repair of porcelain/ composite.
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) |
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3
510(k) Summary Tokuyama Dental Corporation OMNICHROMA FLOW tooth shade resin material
Submitter
(i) 510(k) Submitter
Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo 110-0016 Japan Phone: 011-81-3-3835-2261
(ii) 510(k) Submitter Contact
Keith A. Barritt Fish & Richardson P.C. 1000 Maine Avenue, S.W. Suite 1000 Washington, DC 20024 Phone: (202) 783-5070 Facsimile: (202) 783-2331 Email: barritt@fr.com
(iii) Preparation Date
August 14, 2020
Device
| Trade or Proprietary Name: | OMNICHROMA FLOW |
|---|---|
| Common Name: | tooth shade resin material |
| Classification Name: | material, tooth shade, resin |
| Class: | 2 |
| Product Code: | EBF |
4
Predicate Device
Primary Predicate: Tokuyama Dental Corporation's OMNICHROMA (K#173275) Reference Device: Tokuyama Dental Corporation's ESTELITE UNIVERSAL FLOW (K#180613)
Device Description
The OMNICHROMA FLOW tooth shade resin material is a paste that comes in a plastic syringe (1.8mL). The device is a low viscosity, light-cured, radiopaque composite resin for use in anterior and posterior restorations for all carious classes. OMNICHROMA FLOW is a single shade material. Direct placement of OMNICHROMA FLOW into a prepared cavity allows for easy handling.
OMNICHROMA FLOW is designed to be cured by either a halogen or LED curing-light with a wavelength of 400-500 nm. Be sure to light-cure OMNICHROMA FLOW extra-orally and check the time needed for complete hardening of OMNICHROMA FLOW with your lightcuring unit before performing the bonding procedure.
The device is intended for use by licensed healthcare professionals only. The device does not come sterilized and is not intended to be sterilized prior to use.
The OMNICHROMA FLOW device contains methacrylic monomers and a UV absorber. The device should not be used on patients who are allergic to or hypersensitive to methacrylic and related monomers, UV absorber, or any of the other ingredients.
Indications for Use
The device is indicated for use for direct anterior and posterior restorations, cavity base or liner, and repair of porcelain/composite.
Comparison of Technological Characteristics
The OMNICHROMA FLOW device has the same basic technological characteristics in terms of design, material, and chemical composition as the predicate device identified above, as each device is a tooth shade resin material that is cured by photo polymerization. The OMNICHROMA FLOW device does not have its own energy source.
For purposes of performance characteristics for obtaining FDA marketing authorization, the OMNICHROMA FLOW device is substantially equivalent to Tokuyama's own primary predicate, the OMNICHROMA device (K#173275), as shown below:
5
| Subject device | Primary predicate | Reference | Difference | ||||
|---|---|---|---|---|---|---|---|
| Device name | OMNICHROMA | ||||||
| FLOW | OMNICHROMA | ESTELITE UNIVERSAL | |||||
| FLOW | |||||||
| Manufacturer | Tokuyama Dental | Tokuyama Dental | Tokuyama Dental | ||||
| 510(k) No. | K193537 | ||||||
| (Pending) | K173275 | K180613 | - | ||||
| Health Canada licence No. | 101564 | 101263 | |||||
| Classification name | Material, Tooth | ||||||
| Shade, Resin | Material, Tooth Shade, | ||||||
| Resin | Material, Tooth Shade, | ||||||
| Resin | - | ||||||
| Indications for Use | - Direct anterior and | ||||||
| posterior restorations |
- Cavity base or liner
- Repair of
porcelain/composite | | For use as a tooth shade
resin material in dental
procedures, such as: - Direct anterior and
posterior restorations - Direct bonded
composite veneer - Diastema closure
- Repair of
porcelain/composite | - Direct anterior and
posterior restorations - Cavity base or liner
- Blocking out cavity
undercuts before
fabricating indirect
restorations - Repair of
porcelain/composite | Similar
The indications for
Use of subject device
is within that of the
predicate and
reference devices. | |
| Component | | Container | Syringe
or Pre-
loaded
tip | Syringe or Pre-loaded
tip | Syringe or Pre-loaded
tip | Identical | |
| | | Shade | 1 shade | 1 shade | 12 shade | Similar
The number of shades
of the subject device
is within that of the
predicate and
reference devices. | |
| Principle of operation | | Tooth shade resin
material that is cured
by photo
polymerization.
(Light-cure) | | Tooth shade resin
material that is cured by
photo polymerization.
(Light-cure) | Tooth shade resin
material that is cured by
photo polymerization.
(Light-cure) | Identical | |
| Material | | Filler | - Silica-zirconia filler - Composite filler | - Silica-zirconia filler
- Composite filler | - Silica-zirconia filler
- Composite filler | Similar
The subject device
consists mainly of | |
| | | Resin
matrix
monomer | - 1,6-bis(methacryl-
ethyloxy
carbonylamino)trimet
hyl hexane (UDMA) - Nonamethylenediol
dimethacrylate (ND) | - 1,6-bis(methacryl-
ethyloxy
carbonylamino)trimethy
l hexane (UDMA) - Triethylene glycol
dimethacrylate
(TEGDMA) | - Bisphenol A polyethoxy
methacrylate (Bis-
MPEPP) - Bisphenol A di(2-
hydroxypropoxy)
dimethacrylate (Bis-
GMA) - Triethylene glycol
dimethacrylate
(TEGDMA) - 1,6-bis(methacryl-
ethyloxy
carbonylamino)trimethy
l hexane (UDMA) | fillers and
methacrylates as with
the predicate and
reference devices.
The biocompatibility
of the device has been
thoroughly evaluated
and performance
tested. | |
| Physical
property | Sensitivity
to ambient
light | | Conformed to the
requirement of ISO
4049 | Conformed to the
requirement of ISO
4049 | Conformed to the
requirement of ISO
4049 | Similar but all
devices conform to
the requirements of
ISO 4049 and | |
| | Depth of
cure | | Conformed to the
requirement of ISO
4049 | Conformed to the
requirement of ISO
4049 | Conformed to the
requirement of ISO
4049 | therefore the
subjected device is | |
| | Flexural
strength | | Conformed to the
requirement of ISO
4049 | Conformed to the
requirement of ISO
4049 | Conformed to the
requirement of ISO
4049 | substantially
equivalent. | |
6
| | Water
sorption | Conformed to the
requirement of ISO
4049 | Conformed to the
requirement of ISO
4049 | Conformed to the
requirement of ISO
4049 | |
|---------------|--------------------|---------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|-----------|
| | Solubility | Conformed to the
requirement of ISO
4049 | Conformed to the
requirement of ISO
4049 | Conformed to the
requirement of ISO
4049 | |
| | Color
stability | Conformed to the
requirement of ISO
4049 | Conformed to the
requirement of ISO
4049 | Conformed to the
requirement of ISO
4049 | |
| | Radio-
opacity | Conformed to the
requirement of ISO
4049 | Conformed to the
requirement of ISO
4049 | Conformed to the
requirement of ISO
4049 | |
| Sterilization | | Non-sterile | Non-sterile | Non-sterile | Identical |
| Shelf life | | 3 years at a
temperature between
0-25°C (32-77Fº) | 3 years at a temperature
between
0-25°C (32-77Fº) | 3 years at a temperature
between
0-25°C (32-77Fº) | Identical |
Shelf Life Testing
Tokuyama tested the device to establish a shelf life of three years at a temperature between 0-25°C (32-77F°).
Material And Chemical Composition
The device does come into direct contact with the patient.
For purposes of material and chemical composition, the OMNICHROMA FLOW device has the same basic characteristics as Tokuyama's own OMNICHROMA (K#173275) and ESTELITE UNIVERSAL FLOW (K#180613).
Additional biocompatibility assessment included cytotoxicity, sensitization, oral mucosa irritation, subacute systemic toxicity, acute systemic toxicity, and genotoxicity testing.
Performance Data Summary
Non-clinical testing of the physical properties of the OMNICHROMA FLOW device was conducted in accordance with ISO 4049:2009, "Dentistry -- Polymer-based Restorative Materials." There were no clinical tests performed for the OMNICHROMA FLOW device.
7
| Subject device | Primary predicate | Reference | Difference | ||
|---|---|---|---|---|---|
| Device name | OMNICHROMA | ||||
| FLOW | OMNICHROMA | ESTELITE UNIVERSAL | |||
| FLOW | - | ||||
| Physical | |||||
| property | Sensitivity | ||||
| to ambient | |||||
| light | Conformed to the | ||||
| requirement of ISO | |||||
| 4049 | Conformed to the | ||||
| requirement of ISO | |||||
| 4049 | Conformed to the | ||||
| requirement of ISO 4049 | Similar but all | ||||
| devices | |||||
| conform to the | |||||
| requirements of | |||||
| ISO 4049 and | |||||
| therefore the | |||||
| subjected | |||||
| device is | |||||
| substantially | |||||
| equivalent. | |||||
| Depth of | |||||
| cure | Conformed to the | ||||
| requirement of ISO | |||||
| 4049 | Conformed to the | ||||
| requirement of ISO | |||||
| 4049 | Conformed to the | ||||
| requirement of ISO 4049 | |||||
| Flexural | |||||
| strength | Conformed to the | ||||
| requirement of ISO | |||||
| 4049 | Conformed to the | ||||
| requirement of ISO | |||||
| 4049 | Conformed to the | ||||
| requirement of ISO 4049 | |||||
| Water | |||||
| sorption | Conformed to the | ||||
| requirement of ISO | |||||
| 4049 | Conformed to the | ||||
| requirement of ISO | |||||
| 4049 | Conformed to the | ||||
| requirement of ISO 4049 | |||||
| Solubility | Conformed to the | ||||
| requirement of ISO | |||||
| 4049 | Conformed to the | ||||
| requirement of ISO | |||||
| 4049 | Conformed to the | ||||
| requirement of ISO 4049 | |||||
| Color | |||||
| stability | Conformed to the | ||||
| requirement of ISO | |||||
| 4049 | Conformed to the | ||||
| requirement of ISO | |||||
| 4049 | Conformed to the | ||||
| requirement of ISO 4049 | |||||
| Radio- | |||||
| opacity | Conformed to the | ||||
| requirement of ISO | |||||
| 4049 | Conformed to the | ||||
| requirement of ISO | |||||
| 4049 | Conformed to the | ||||
| requirement of ISO 4049 | |||||
| Sterilization | Non-sterile | Non-sterile | Non-sterile | Identical | |
| Shelf life | 3 years at a | ||||
| temperature between | |||||
| 0-25°C (32-77F°) | 3 years at a temperature | ||||
| between | |||||
| 0-25°C (32-77F°) | 3 years at a temperature | ||||
| between | |||||
| 0-25°C (32-77F°) | Identical |
Comparison of OMNICHROMA FLOW device with the primary predicate and reference device:
Conclusion
Based on the non-clinical testing conducted of the physical properties of the OMNICHROMA FLOW device in comparison to the predicate device identified above, and based on the biocompatibility of authorized devices with similar ingredients for the same use and additional biocompatibility testing, it is concluded that the OMNICHROMA FLOW device is substantially equivalent to the predicate device.
41429091.doc