(239 days)
No
The summary describes a dental restorative composite material and its physical properties, with no mention of AI or ML technology.
No
The device is a restorative composite used for direct restorations, not for treating diseases or conditions.
No
The device description clearly states it is a "light-cured restorative composite" used for direct restorations, veneers, and correction of tooth shape. These are therapeutic and restorative applications, not diagnostic ones.
No
The device description clearly states it is an "intra-oral, light-cured restorative composite" available via "syringe and replaceable tips," indicating it is a physical material and delivery system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses are all related to direct dental restorations and repairs within the mouth. This is a therapeutic and restorative function, not a diagnostic one performed on samples outside the body.
- Device Description: The description clearly states it's a "light-cured restorative composite" for "intra-oral" use. This aligns with a material used for treating or restoring tissue, not for diagnosing a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on physical and mechanical properties relevant to a restorative material (according to ISO 4049), not on diagnostic accuracy metrics like sensitivity, specificity, or AUC.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on restoring and repairing dental structures within the patient's mouth.
N/A
Intended Use / Indications for Use
[1] Direct restorations for all cavity classes in anterior and posterior teeth
[2] Direct veneers
[3] Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
[4] Intraoral repairs of fractured restorations
Product codes
EBF
Device Description
CLEARFIL MAJESTY IC is an intra-oral, light-cured restorative composite that is available direct injection method into preparations with its syringe and replaceable tips. It is the radiopaque equivalent of 1mm aluminium and classified as a Type 1 and Class 2 (Group 1) material by ISO 4049. It is indicated for both anterior and posterior restorations and provides accurate color matching, high polishability and excellent physical properties.
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
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)
Physical and mechanical properties of the subject device were evaluated according to ISO 4049: 2009 (Dentistry - Polymer-based restorative and materials). According to ISO 4049: 2009, the subject device is classified into the following:
- Type 1: Polymer-based restorative materials;
- Class 2: materials whose setting is effected by light;
- Group 1: materials whose use requires the energy to be applied intra-orally.
In addition, we examined the subject device concerning the Physical Properties described in the "Dental Composite Resin Devices – Premarket Notification [510(k)] Submissions – Guidance for Industry and FDA Staff".
Therefore, we considered sensitivity to ambient light, Depth of cure, flexural strength, water sorption and solubility, shade, filling and restorative materials, color stability after irradiation and water sorption, radio-opacity, compressive strength, elastic modulus, intensity for curing, wavelength for curing, filler particle size distribution, surface hardness and curing time as physical properties when testing the subject device. The subject device doesn't contain chemical ingredients which are corresponded releasable agents "such as fluoride or nitrate ions". The compared test items and the evaluation results are described as follows.
All of tests results demonstrated that each characteristic of the subject device is substantially equivalent to that of the primary predicate device or the reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K121583, K130371, K042929, K163207, K092281
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 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.
May 3, 2019
Kuraray Noritake Dental Inc. Yasujiro Ohara Manager Ote Center Bldg. 7F, 1-1-3, Otemachi Chiyoda-ku, Tokyo 100-0004 JAPAN
Re: K182430
Trade/Device Name: CLEARFIL MAJESTY IC Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: January 31, 2019 Received: February 4, 2019
Dear Yasujiro Ohara:
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.
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
for Malvina Eydelman, M.D. Director 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): K182430
Device Name: CLEARFIL MAJESTY IC
Indications for Use:
[1] Direct restorations for all cavity classes in anterior and posterior teeth
[2] Direct veneers
[3] Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
[4] Intraoral repairs of fractured restorations
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
510(k) Summary
Kuraray Noritake Dental Inc.
CLEARFIL MAJESTY IC
Dental light-cured restorative composite
21 CFR 872.3690
EBF
3-1. 510(k) owner (submitter)
-
- Name
-
- Address
-
- Contact person
- Contact person in US
1621 Sakazu, Kurashiki, Okayama 710-0801, Japan Yasujiro Ohara Quality Assurance Department Manabu Suzuki KURARAY AMERICA, INC. 33 Maiden Lane, 6th Floor, New York, NY 10038 Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676 Fax: (212)-867-3543
3-2. Name of Device
-
- Trade / Proprietary Name:
-
- Regulation Number:
-
- Product Code:
-
- Common Name
3-3. Primary Predicate Device
| CLEARFIL MAJESTY ES-2 | 510(k) Number:
Classification:
Product Code:
21 CFR:
Applicant: | K121583
Tooth shade resin material
EBF
872.3690
Kuraray Noritake Dental Inc. |
|----------------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| CLEARFIL MAJESTY ES Flow | 510(k) Number:
Classification:
Product Code:
21 CFR:
Applicant: | K130371
Tooth shade resin material
EBF
872.3690
Kuraray Noritake Dental Inc. |
| ESTENIA C&B | 510(k) Number:
Classification:
Product Code:
21 CFR:
Applicant: | K042929
Tooth shade resin material
EBF
872.3690
Kuraray Noritake Dental Inc. |
| Filtek One Bulk Fill Restorative | 510(k) Number:
Classification:
Product Code:
21 CFR:
Applicant: | K163207
Tooth shade resin material
EBF
872.3690
3M Company |
| CLEARFIL MAJESTY Posterior PLT | 510(k) Number:
Classification:
Product Code:
21 CFR:
Applicant: | K092281
Tooth shade resin material
EBF
872.3690 |
4
| Applicant: | Kuraray Noritake Dental Inc. | |
|---|---|---|
| EPRICORD | 510(k) Number: | K033267 |
| Classification: | Tooth shade resin material | |
| Product Code: | EBF | |
| 21 CFR: | 872.3690 | |
| Applicant: | Kuraray Noritake Dental Inc. |
3-4. Device Description
CLEARFIL MAJESTY IC is an intra-oral, light-cured restorative composite that is available direct injection method into preparations with its syringe and replaceable tips. It is the radiopaque equivalent of 1mm aluminium and classified as a Type 1 and Class 2 (Group 1) material by ISO 4049. It is indicated for both anterior and posterior restorations and provides accurate color matching, high polishability and excellent physical properties.
3-5. Indications for Use Statement
The subject device is indicated for the following uses:
- [1] Direct restorations for all cavity classes in anterior and posterior teeth
- [2] Direct veneers
- [3] Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
- [4] Intraoral repairs of fractured restorations
3-6. Substantial Equivalence Discussion
1) Indications for Use
The Indications for Use of the subject device is identical to the primary predicate device. Therefore, the Indications for Use of the subject device is substantially equivalent to that of the primary predicate device.
The indications of the subject device and the primary predicate device are as listed on the following table.
| Subject device | Primary predicate device | |
|---|---|---|
| Trade name | CLEARFIL MAJESTY IC | CLEARFIL MAJESTY ES-2 |
| Indications | ||
| for Use | [1] Direct restorations for all cavity classes in | |
| anterior and posterior teeth | ||
| [2] Direct veneers | ||
| [3] Correction of tooth position and tooth shape | ||
| (e.g. diastema closure, dwarfed tooth, etc.) | ||
| [4] Intraoral repairs of fractured restorations | [1] Direct restorations for all cavity classes in | |
| anterior and posterior teeth | ||
| [2] Direct veneers | ||
| [3] Correction of tooth position and tooth shape | ||
| (e.g. diastema closure, dwarfed tooth, etc.) | ||
| [4] Intraoral repairs of fractured restorations |
Table 3-6. Indications for Use of the subject device and the primary predicate device
2) Chemical ingredients
All ingredients in the subject device and its accessories have been used in the primary predicate device and the reference devices.
Regarding the primary predicate device and the reference devices, there have not been any reported problems or recalls according to the post-market adverse event reporting requirements in the US.
The chemical ingredients of the subject device and its accessories are equivalent to those of the primary predicate device and the reference devices.
5
- Technological characteristics/ Non-Clinical Testing
Physical and mechanical properties of the subject device were evaluated according to ISO 4049: 2009 (Dentistry - Polymer-based restorative and materials). According to ISO 4049: 2009, the subject device is classified into the following:
- Type 1: Polymer-based restorative materials;
- Class 2: materials whose setting is effected by light;
- Group 1: materials whose use requires the energy to be applied intra-orally.
In addition, we examined the subject device concerning the Physical Properties described in the "Dental Composite Resin Devices – Premarket Notification [510(k)] Submissions – Guidance for Industry and FDA Staff".
Therefore, we considered sensitivity to ambient light, Depth of cure, flexural strength, water sorption and solubility, shade, filling and restorative materials, color stability after irradiation and water sorption, radio-opacity, compressive strength, elastic modulus, intensity for curing, wavelength for curing, filler particle size distribution, surface hardness and curing time as physical properties when testing the subject device. The subject device doesn't contain chemical ingredients which are corresponded releasable agents "such as fluoride or nitrate ions". The compared test items and the evaluation results are described as follows.
6
| Test item | For comparison:
Primary Predicate device
or
Reference device | Result |
|------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------|
| Sensitivity to ambient light | Primary Predicate device | The result demonstrated substantial equivalence. |
| Depth of cure | Primary Predicate device | The result demonstrated substantial equivalence. |
| Flexural strength | Primary Predicate device | The result demonstrated substantial equivalence. |
| Water sorption and solubility | Primary Predicate device | The result demonstrated substantial equivalence. |
| Shade, filling and restorative materials | Primary Predicate device | The result demonstrated substantial equivalence. |
| Color stability after
irradiation and water
sorption | Primary Predicate device | The result demonstrated substantial equivalence. |
| Radio-opacity | Primary Predicate device | The result demonstrated substantial equivalence. |
| Compressive strength | Primary Predicate device | The result demonstrated substantial equivalence. |
| Elastic modulus | Primary Predicate device
Reference device | The result demonstrated substantial equivalence. |
| Intensity for curing | Primary Predicate device | The result demonstrated substantial equivalence. |
| Wavelength for curing | Primary Predicate device | The result demonstrated substantial equivalence. |
| Filler particle size
distribution | Primary Predicate device | The result demonstrated substantial equivalence. |
| Surface hardness | Primary Predicate device | The result demonstrated substantial equivalence. |
| Curing time | Primary Predicate device | The result demonstrated substantial equivalence. |
So we conducted the comparative tests for above test items. And all of tests results demonstrated that each characteristic of the subject device is substantially equivalent to that of the primary predicate device or the reference devices.
7
The subject device is categorized into the external communicating device (dentin) and permanent contact device.
All the chemical ingredients of the subject device are equivalent to those of the primary predicate device and the reference devices.
Contacting information about the accessories of the subject device is as follows;
| Item | Human contacting information | The reference device |
|---|---|---|
| Syringe | Indirect | CLEARFIL MAJESTY ES Flow |
| Dispensing tip | Direct | 510(k) Number; K130371 |
| Dispensing tip cap | Indirect | CLEARFIL MAJESTY Posterior PLT |
| 510(k) Number; K092281 |
All the chemical ingredients of accessories about the subject device are equivalent to those of the reference device.
And biological evaluation was conducted according to ISO10993-1:2009.
Concerning the track records of the ingredients, Indications for Use, manufacturing process, contact part and contact duration, all of these are substantially equivalent to those of the primary predicate device and the reference devices.
Therefore, the subject device and its accessories are substantially equivalent in biocompatibility to the primary predicate device and the reference devices.
Concerning Shelf Life, the subject device was evaluated by using temperature accelerated samples. And the properties of them which are equivalent to storing at 25°C/ 77 °F more than 48 months were complied with ISO 4049: 2009. So the Shelf Life of the subject device was determined to be 48 months at 2-25 °C/ 36-77 °F.
3-7. Conclusion
The comparison for Indications for Use, chemical ingredients and performance data shows that the subject device is substantially equivalent to the primary predicate device and the reference devices.