(56 days)
No
The device description and performance studies focus on the material properties and physical performance of a dental composite resin, with no mention of AI or ML.
No
A therapeutic device is used to treat a disease or condition. This device is a resin material used for dental restorations, which is a reconstructive rather than a therapeutic purpose.
No
Explanation: The device is a resin material used for dental restorations, not for diagnosing conditions.
No
The device description clearly states it is a "low viscosity, light-cured, radiopaque composite tooth shade resin material," which is a physical substance, 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 direct dental restorations, cavity bases, blocking undercuts, and repairing porcelain/composite. These are all procedures performed directly on the patient's tooth.
- Device Description: The device is a composite resin material applied directly to the tooth.
- Lack of In Vitro Testing: The description of performance studies mentions non-clinical testing of physical properties according to ISO 4049, which is for polymer-based restorative materials. There is no mention of testing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a restorative material used in a dental procedure, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
For use as a tooth shade resin material in dental procedures such as:
- Direct anterior and posterior restorations
- Cavity base or liner
- Blocking out cavity undercuts before fabricating indirect restorations
- Repair of porcelain/composite
Product codes
EBF
Device Description
The OMNICHROMA FLOW BULK is a low viscosity, light-cured, radiopaque composite tooth shade resin material for use in anterior and posterior restorations and is indicated for all carious classes. The OMNICHROMA FLOW BULK device is a single shade material. Direct placement of the OMNICHROMA FLOW BULK device into a prepared cavity allows for easily handling. The OMNICHROMA FLOW BULK device is a flowable material which can be placed in 3.5mm increments.
The OMNICHROMA FLOW BULK device contains 1,6-bis(methacrylethyloxycarbonylamino)trimethyl hexane (UDMA), triethylene glycol dimethacrylate (TEGDMA), mequinol, dibutyl hydroxyl toluene, and UV absorber.
OMNICHROMA FLOW BULK is designed to be cured by either a halogen or LED curing-light with a wavelength of 400-500 nm.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed healthcare professionals only.
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 BULK device was conducted in accordance with ISO 4049:2009, "Dentistry -- Polymer-based Restorative Materials." There were no clinical tests performed for the OMNICHROMA FLOW BULK device.
Key results:
- Sensitivity to ambient light: Conformed to the requirement of ISO 4049
- Depth of cure: Conformed to the requirement of ISO 4049
- Flexural strength: Conformed to the requirement of ISO 4049
- Water sorption: Conformed to the requirement of ISO 4049
- Solubility: Conformed to the requirement of ISO 4049
- Color stability: Conformed to the requirement of ISO 4049
- Radio-opacity: Conformed to the requirement of ISO 4049
- Shelf life: 3 years at a temperature between 0-25°C (32-77F°)
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 the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 3, 2021
Tokuyama Dental Corporation % Keith Baritt Correspondent Fish & Richardson P.C. 1000 Maine Avenue, S.W. Suite 1000 Washington, District of Columbia 20024
Re: K203598
Trade/Device Name: Omnichroma Flow Bulk Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: December 8, 2020 Received: December 9, 2020
Dear Keith Baritt:
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
1
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 medical devices and radiation-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 Michael Adjodha Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203598
Device Name
OMNICHROMA FLOW BULK
Indications for Use (Describe)
For use as a tooth shade resin material in dental procedures such as:
- Direct anterior and posterior restorations
- Cavity base or liner
- Blocking out cavity undercuts before fabricating indirect restorations
- Repair of porcelain/composite
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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3
510(k) Summary Tokuyama Dental Corporation OMNICHROMA FLOW BULK 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
February 2, 2021
Device
| Trade or Proprietary Name: | OMNICHROMA FLOW BULK |
|---|---|
| Common Name: | tooth shade resin material |
| Classification Name: | material, tooth shade, resin |
| Class: | 2 |
| Product Code: | EBF |
4
Predicate Device
| Primary Predicates: Tokuyama Dental Corp.'s ESTELITE BULK FILL Flow (K#161353) and
| OMNICHROMA FLOW (K#193537) |
|---|
| Reference Devices for Performance: |
| Tokuyama Dental Corp.'s ESTELITE UNIVERSAL FLOW High |
| (K#180613) |
| Additional Reference Devices for Biocompatibility: |
| Tokuyama Dental Corp.'s OMNICHROMA (K#173275) and |
| ESTELITE FLOW QUICK High Flow (K#051808) |
Device Description
The OMNICHROMA FLOW BULK is a low viscosity, light-cured, radiopaque composite tooth shade resin material for use in anterior and posterior restorations and is indicated for all carious classes. The OMNICHROMA FLOW BULK device is a single shade material. Direct placement of the OMNICHROMA FLOW BULK device into a prepared cavity allows for easily handling. The OMNICHROMA FLOW BULK device is a flowable material which can be placed in 3.5mm increments.
The OMNICHROMA FLOW BULK device contains 1,6-bis(methacrylethyloxycarbonylamino)trimethyl hexane (UDMA), triethylene glycol dimethacrylate (TEGDMA), mequinol, dibutyl hydroxyl toluene, and UV absorber.
OMNICHROMA FLOW BULK is designed to be cured by either a halogen or LED curing-light with a wavelength of 400-500 nm.
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.
Indications for Use
For use as a tooth shade resin material in dental procedures such as:
- Direct anterior and posterior restorations
- Cavity base or liner
- Blocking out cavity undercuts before fabricating indirect restorations
- Repair of porcelain/composite
Comparison of Technological Characteristics
The OMNICHROMA FLOW BULK 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 BULK device does not have its own energy source.
5
For purposes of performance characteristics for obtaining FDA marketing authorization, the OMNICHROMA FLOW BULK device is substantially equivalent to Tokuyama's own predicate devices, the ESTELITE BULK FILL Flow device (K#161353) and the OMNICHROMA FLOW (K#193537), as shown below:
| Subject device | Predicate #1 | Predicate #2 | Difference | ||
|---|---|---|---|---|---|
| Device name | OMNICHROMA FLOW | ||||
| BULK | ESTELITE BULK FILL | ||||
| Flow | OMNICHROMA | ||||
| FLOW | - | ||||
| Manufacturer | Tokuyama Dental | Tokuyama Dental | Tokuyama Dental | - | |
| 510(k) No. | K203598 | K161353 | K193537 | - | |
| Health Canada licence No. | (Pending) | 98095 | 104170 | - | |
| Classification name | Material, Tooth Shade, | ||||
| Resin | Material, Tooth Shade, | ||||
| Resin | Material, Tooth Shade, | ||||
| Resin | - | ||||
| Indications for Use | For use as a tooth shade | ||||
| resin material in dental | |||||
| procedures such as: |
- Direct anterior and
posterior restorations - Cavity base or liner
- Blocking out cavity
undercuts before
fabricating indirect
restorations - Repair of
porcelain/composite | For use as a tooth shade
resin material in dental
procedures such as: - Direct anterior and
posterior restorations - Cavity lining
- Blocking out cavity
undercuts before
fabricating indirect
restorations - Repair of
porcelain/composite | - Direct anterior and
posterior
restorations - Cavity base or liner
- Repair of
porcelain/composite | Similar
The indications
for Use of subject
device is within
that of the
predicate and
reference devices. |
| Component | Container | Syringe | Syringe or Pre-loaded tip | Syringe | Similar
The container
type of subject
device is within
that of the
predicate and
reference devices. |
| | Shade | 1 shade | 4 shades | 1 shade | Similar
The number of
shade of 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 fillers
and methacrylates
as with the
predicate and
reference devices.
The
biocompatibility
of the device has
been thoroughly
evaluated and
performance
tested. |
| | Resin matrix
monomer | -1,6-bis(methacryl-ethyloxy
carbonylamino)trimethyl
hexane (UDMA)
-Triethylene glycol
dimethacrylate
(TEGDMA) | - Bisphenol A di(2-
hydroxypropoxy)
dimethacrylate (Bis-
GMA) - Bisphenol A
polyethoxy
methacrylate (Bis-
MPEPP) - Triethylene glycol
dimethacrylate
(TEGDMA) | -1,6-bis(methacryl-
ethyloxy
carbonylamino)trimet
hyl hexane (UDMA)
-Nonamethylenediol
dimethacrylate (ND) | |
| 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 |
| | Depth of cure | Conformed to the
requirement of ISO 4049 | Conformed to the
requirement of ISO 4049 | Conformed to the
requirement of ISO
4049 | requirements of
ISO 4049 and
therefore the |
| | Flexural
strength | Conformed to the
requirement of ISO 4049 | Conformed to the
requirement of ISO 4049 | Conformed to the
requirement of ISO
4049 | subjected device
is substantially
equivalent. |
| | 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 |
6
Shelf Life Testing
Tokuyama tested the device to establish a shelf life of three years at a temperature between 0-25°C (32-77F°).
7
Material And Chemical Composition
The device does come into direct contact with the patient. However, all of the ingredients contained in OMNICHROMA FLOW BULK are used in Tokuyama Dental Corp.'s OMNICHROMA (K#173275), OMNICHROMA FLOW (K#193537), and ESTELITE FLOW QUICK High Flow (K#051808).
Performance Data Summary
Non-clinical testing of the physical properties of the OMNICHROMA FLOW BULK device was conducted in accordance with ISO 4049:2009, "Dentistry -- Polymer-based Restorative Materials." There were no clinical tests performed for the OMNICHROMA FLOW BULK device.
A comparison of the OMNICHROMA FLOW BULK device with the predicate devices shown below:
| Subject device | Predicate #1 | Predicate #2 | Difference | ||
|---|---|---|---|---|---|
| Device name | OMNICHROMA FLOW | ||||
| BULK | ESTELITE BULK FILL | ||||
| Flow | OMNICHROMA 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 |
8
Conclusion
Based on the non-clinical testing conducted of the physical properties of the OMNICHROMA FLOW BULK 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 BULK device is substantially equivalent to the predicate devices.