(162 days)
No
The device is a dental cleaning agent and the summary focuses on its chemical properties and performance in shear bond strength tests. There is no mention of AI or ML.
No.
The device is a dental cleaning agent used to prepare surfaces for optimal adhesive results; it does not treat or prevent disease.
No
The device is described as a dental cleaning agent designed to prepare surfaces for optimal adhesive results in dental restorations. Its performance is evaluated based on shear bond strength, which is a measure of adhesion, not diagnosis. The "Intended Use / Indications for Use" and "Device Description" clearly state its function as a cleaning agent for contaminated surfaces.
No
The device is described as a "dental cleaning agent" and its performance is evaluated through "Shear bond strength tests" and "Biocompatibility Testing," which are typical for physical or chemical substances, not software. There is no mention of software components, algorithms, or digital processing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cleaning dental surfaces (restorations, prepared teeth, implant abutments) in vivo (within the mouth) to improve adhesive bonding. This is a direct application to the patient's body.
- Device Description: The description reinforces its use as a dental cleaning agent applied to surfaces within the mouth.
- Lack of IVD Characteristics: There is no mention of analyzing samples in vitro (outside the body) to provide diagnostic information about a patient's health. IVDs typically involve testing blood, urine, tissue, or other bodily fluids or samples.
- Performance Studies: The performance studies focus on shear bond strength and biocompatibility, which are relevant to a device used directly on dental structures, not for in vitro analysis.
Therefore, this device falls under the category of a dental medical device used for treatment or preparation within the oral cavity, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- [1] Cleaning of contaminated glass ceramic, zirconia, resin restorations, metal restorations and fiber post after intraoral try-in.
- [2] Cleaning for contaminated prepared tooth (cavity, root canal and tooth abutment), and implant abutment
Product codes (comma separated list FDA assigned to the subject device)
PME, LBH
Device Description
This subject device is a dental cleaning agent suitable for non-abrasive cleaning of the bonding surfaces of prosthetic restorations after intraoral try-in.
It is also suitable for cleaning a contaminated prepared cavity, root canal, and tooth/ implant abutment. It is used in helping to achieve optimal adhesive results.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Contaminated prepared tooth (cavity, root canal and tooth abutment), and implant abutment.
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)
Bench Testing:
Shear bond strength tests to the adherent surfaces were performed on this device considering its intended use, in comparison with the predicate devices and the reference device. Since this subject device is a dental cleaning agent. in order to evaluate its performance, the adherents were contaminated with artificial saliva prior to the shear bond strength test.
Evaluation Items: Appearance, Coating property, Shear bond strength (contaminated by artificial saliva) on Bovine Dentin, Metal (Titan100), and Ceramics (KATANA Zirconia HT), pH (before rinse/ after rinse), Water solubility, SEM and EDX Surface Comparison, Staining Test.
Key Results:
- Appearance and Coating property: No difference among the subject device, the predicate device and the reference device.
- Shear bond strength: Each shear bond strength of the subject device such as "Just after prepared" and "for 3 weeks at 70 ℃/ 158 °F." is equal to "Positive control (Without contamination and applying the subject device)". Shear bond strength of the subject device is higher than that of "Negative control (without the subject device)" where the adherent surface is contaminated by artificial saliva. This indicates good performance as a cleaning agent. Results showed equal to or greater than those of the predicate device and the reference device.
- pH: The value of the subject device is located between the values of predicate device and the reference device, considered substantially equivalent.
- Staining Test: The subject device was colored and substantially equivalent to the predicate device and the reference device.
- Water solubility: The subject device was easily removed from substrate. At "pH (after rinse)", the value of the subject device showed the same value of control which is not applying any devices.
- SEM and EDX Surface Comparison: Peak area ratio of the subject device is the same as the value of control and the predicate device and reference device. The subject device can be easily rinsed with water.
Biocompatibility Testing:
Evaluated according to "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff" and "ISO 10993-1:2018".
Conclusion: The subject device is substantially equivalent to the reference devices.
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.
K163171, K990040, K042913, K133078, K033938
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
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
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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 & 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.
October 8, 2019
Kuraray Noritake Dental Inc. Yasujiro Ohara Manager, Quality Assurance Department Ote Center Bldg. 7F Chiyoda-ku, 100-0004 JAPAN
Re: K191133
Trade/Device Name: KATANA Cleaner, KATANA Cleaner (Trial) Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: Class II Product Code: PME, LBH Dated: September 6, 2019 Received: September 12, 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.
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 Nandkumar, Ph.D. Acting 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): K191133
Device Name: KATANA Cleaner
Indications for Use:
- [1] Cleaning of contaminated glass ceramic, zirconia, resin restorations, metal restorations and fiber post after intraoral try-in.
- [2] Cleaning for contaminated prepared tooth (cavity, root canal and tooth abutment), and implant abutment
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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
1.510(k) owner (submitter)
| 1) Name | Kuraray Noritake Dental Inc. |
|---|---|
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-0801, Japan |
| 3) Contact person | Yasujiro Ohara |
| Manager | |
| Quality Assurance Department | |
| Knd.Regist@kuraray.com | |
| 4) Contact person in US | Manabu Suzuki |
| Director | |
| Dental Material Division | |
| 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 | |
| 2.Date: | 7th October, 2019 |
| 3.Name of Device |
| 1) Trade / Proprietary name | KATANA Cleaner |
|---|---|
| 2) Classification Name | External Cleaning Solution |
| 21 CFR 872.3260 | |
| PME | |
| Subsequent Product Code: LBH | |
| (Cavity Varnish) |
- Common Name
Dental Cleaning Agent
4
| 4. Predicate Device | ||
|---|---|---|
| 1) CONSEPSIS | 510(k) Number: | |
| Classification: | ||
| Product Code: | ||
| 21 CFR: | ||
| Applicant: | K925375 | |
| Cavity Varnish | ||
| LBH | ||
| 872.3260 | ||
| ULTRADENT PRODUCTS, INC. | ||
| 5.Reference Devices | ||
| 1) Zirclean | 510(k) Number: | |
| Classification: | ||
| Product Code: | ||
| 21 CFR: | ||
| Applicant: | K163171 | |
| External Cleaning Solution | ||
| PME | ||
| 872.3260 | ||
| Bisco, Inc. | ||
| 2) CLEARFIL SE BOND | 510(k) Number: | |
| Classification: | ||
| Product Code: | ||
| 21 CFR: | ||
| Applicant: | K990040 | |
| Agent, Tooth Bonding, Resin | ||
| KLE | ||
| 872.3200 | ||
| Kuraray Noritake Dental Inc. | ||
| 3) CLEARFIL TRI-S BOND | 510(k) Number: | |
| Classification: | ||
| Product Code: | ||
| 21 CFR: | ||
| Applicant: | K042913 | |
| Agent, Tooth Bonding, Resin | ||
| KLE | ||
| 872.3200 | ||
| Kuraray Noritake Dental Inc. | ||
| 4) K-ETCHANT Syringe | 510(k) Number: | |
| Classification: | ||
| Product Code: | ||
| 21 CFR: | ||
| Applicant: | K133078 | |
| Agent, Tooth Bonding, Resin | ||
| KLE | ||
| 872.3200 | ||
| Kuraray Noritake Dental Inc. | ||
| 5) CLEARFILSE Protect | 510(k) Number: | |
| Classification: | ||
| Product Code: | ||
| 21 CFR: | ||
| Applicant: | K033938 | |
| Agent, Tooth Bonding, Resin | ||
| KLE | ||
| 872.3200 | ||
| Kuraray Noritake Dental Inc. |
6.Device Description
This subject device is a dental cleaning agent suitable for non-abrasive cleaning of the bonding surfaces of prosthetic restorations after intraoral try-in.
It is also suitable for cleaning a contaminated prepared cavity, root canal, and tooth/ implant abutment. It is used in helping to achieve optimal adhesive results.
7.Statement of Indication for Use
The subject device is indicated for the following uses:
- [1] Cleaning of contaminated glass ceramic, zirconia, resin restorations, metal restorations and fiber post after intraoral try-in.
- [2] Cleaning for contaminated prepared tooth (cavity, root canal and tooth abutment), and implant abutment.
5
8.Substantial Equivalence Discussion
- Indication for Use
Indication for Use of the subject device, the predicate device and the reference device listed on the following table.
| Trade name | Indication for Use | |
|---|---|---|
| Subject | ||
| device | KATANA | |
| Cleaner | [1] Cleaning of contaminated glass ceramic, zirconia, resin restorations, | |
| metal restorations and fiber post after intraoral try-in.. | ||
| [2] Cleaning for contaminated prepared tooth (cavity, root canal and tooth | ||
| abutment), and implant abutment. | ||
| Predicate | ||
| device | CONSEPSIS | |
| (K925375) | Consepsis liquid is used before crown cementation (temporary and/or | |
| permanent) and for restorative preparation of crowns, inlays, and | ||
| composite. | ||
| Consepsis is a demonstrated, quality wetting agent for bonding, and | ||
| increasing bond strength. | ||
| Consepsis recommended for procedural endodontic disinfection, as a final | ||
| endodontic rinse prior to canal obturation and as an antimicrobial prior to | ||
| pulp capping. | ||
| Consepsis helps prevent the influx of micro-organisms into dentinal | ||
| tubules. | ||
| A clinician can reduce potential post-op pulpitis and sensitivity by | ||
| thoroughly cleaning and disinfecting preparations with Consepsis before | ||
| sealing and restoring. | ||
| Reference | ||
| device | ZirClean | |
| (K163171) | This device is an extra oral cleaner of pre-treated ceramic, zirconia and | |
| metal restoration surfaces which have been contaminated during intraoral | ||
| try-in. |
| Table: Indication for Use of the subject device, the predicate device and the reference device | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ------------------------------------------------------------------------------------------------ |
The subject device is substantially equivalent to CONSEPSIS (Predicate device) in that it can be used not only extra-orally for prior to cementation but also intra-orally for prior to sealing and restoring.
In terms of being used for dental prostheses, since CONSEPSIS (Predicate device) is used before crown cementation and for restorative preparation of crowns, inlays, and composite, Indication for Use [1] of the subject device is substantially equivalent to CONSEPSIS.
In addition, Indication for Use [1] is substantially equivalent to that of Zirclean due to clean pre-treated ceramic, zirconia and metal restoration surfaces.
In terms of being used for the tooth structure intra-orally, since CONSEPSIS (Predicate device) is used to thoroughly clean and disinfect the preparation prior to sealing and restoring, Indication for Use [2] of the subject device is substantially equivalent to CONSEPSIS.
The subject device is NOT used to disinfect.
Therefore, Indication for Use of the subject device is substantially equivalent to that of the predicate device.
- . Chemical ingredients
The subject device is categorized into the external communicating device (tissue/ bone/ dentin) and limited exposure device (contact to teeth less than 24hours).
All chemical ingredients of the subject device have been proven to be blended with our own reference devices. However, the chemical material percentage of the subject device differs from the reference devices. Thus, we evaluated whether this change result in an adverse biological response.
In addition, the manufacturing process of the subject device is substantially equivalent to those of the
6
reference devices in point of view of equipment, temperature, pressure and time.
Furthermore, these manufacturing processes do not include sterilization processes.
Regarding the reference devices (In-house device), there have not been any reported problems or recalls according to the post market adverse event reporting requirements in the US.
Since the contact site of the subject device is identical to those of the reference devices (contact to dentin), and the contact duration of the subject device is shorter than those of reference devices, we concluded that the risks by the ingredients of the subject is lower and safer than reference devices.
From the above, it was concluded that the subject device is substantially equivalent to the reference devices.
7
- . Comparison of Technological Characteristics Comparison of Technological characteristics table is shown below:
Table Comparison of Technological characteristics
| Table Comparison of Technological characteristics | ||||
|---|---|---|---|---|
| KATANA | ||||
| Cleaner | ||||
| K191133 | Predicate | |||
| device | ||||
| (CONSEPSIS) | ||||
| (K925375) | Reference | |||
| device | ||||
| (ZirClean) | ||||
| (K163171) | ||||
| Active ingredient | MDP * | |||
| ammonium salt | Chlorohexidine | Potassium | ||
| Hydroxide | ||||
| Operating principle for the | ||||
| cleaning ability to the | ||||
| contaminated adherent | Micelle | Bactericidal | Alkaline | |
| cleaning effect | ||||
| Physical /Mechanical | ||||
| Properties | ||||
| Shear Bond Strength | ||||
| (modified | ||||
| ISO/TS 11405:2015) | Removes | |||
| saliva | ||||
| contamination | Removes | |||
| saliva | ||||
| contamination | Removes saliva | |||
| contamination | ||||
| Method of | ||||
| Application | Brush | Syringe or | ||
| Dispenser | Syringe tip | |||
| or brush | ||||
| Method of | ||||
| Cleaning | Abrasive | Non-abrasive | Non-abrasive | |
| Device Geometry | Liquid | Liquid | Gel | |
| Method of Removal | Water rinsed & | |||
| air dried | Air dry | Water spray & air | ||
| dried | ||||
| Delivery configuration | Bottle | Syringe or | ||
| Dispenser | Syringe or | |||
| Bottle | ||||
| Removal | Water Soluble | Water Soluble | Water Soluble | |
| Chemical Composition | ||||
| Composition | Water | |||
| based liquid | Water | |||
| based liquid | Water based gel | |||
| Viscosity modifier | Polyethylene | |||
| glycol | — | Xanthum Gum | ||
| pH after rinsing | Neutral | Neutral | Neutral | |
| Water Solubility | Water Soluble | Water Soluble | Water Soluble | |
| Pigmented | Yes-Purple | Yes-Blue | Yes-Blue |
- MDP is abbreviation of 10-methacryloyloxydecyl dihydrogen phosphate.
8
9. Non-Clinical Performance Testing
Shear bond strength tests to the adherent surfaces were performed on this device considering its intended use, in comparison with the predicate devices and the reference device. Since this subject device is a dental cleaning agent. in order to evaluate its performance, the adherents
were contaminated with artificial saliva prior to the shear bond strength test.
| Table Comparison with Predicate device and Reference device | |||
|---|---|---|---|
| Evaluation Item | | Criteria | Subject Device
(KATANA Cleaner) | Predicate device
(CONSEPSIS) | Reference
device
(ZirClean) |
|---------------------------------------------------------------------|-------------------------------------|----------------------|------------------------------------|---------------------------------|-----------------------------------|
| Appearance | | In-house
standard | COMPLIES | COMPLIES | COMPLIES |
| Coating property | | In-house
standard | COMPLIES | COMPLIES | COMPLIES |
| Shear
bond strength
(contaminated
by artificial
saliva) | Bovine
Dentin | In-house
standard | COMPLIES | COMPLIES | |
| | Metal
(Titan100) | In-house
standard | COMPLIES | COMPLIES | COMPLIES |
| | Ceramics
(KATANA
Zirconia HT) | In-house
standard | COMPLIES | COMPLIES | COMPLIES |
| | pH
(before rinse/ after rinse) | | In-house
Standard | COMPLIES | COMPLIES |
| Water solubility | | In-house
Standard | COMPLIES | COMPLIES | COMPLIES |
| SEM and EDX Surface
Comparison | | In-house
Standard | COMPLIES | COMPLIES | COMPLIES |
Regarding "Appearance" and "Coating property", there are no difference among the subject device, the predicate device and the reference device.
Each shear bond strength of the subject device such as "Just after prepared" and "for 3 weeks at 70 ℃/ 158 °F." is equal to "Positive control (Without contamination and applying the subject device)". And shear bond strength of the subject device is higher than that of "Negative control (without the subject device)" where the adherent surface is contaminated by artificial saliva. It indicates that the subject device shows the good performance as cleaning agent. In comparison with the predicate device and reference device, the subject device's results showed equal to or greater than those of the predicate device and the reference device.
Regarding pH, the value of the subject device is located between the values of predicate device and the reference device. So, it is considered that pH of the subject device is substantially equivalent to those of the predicate device and the reference device.
For "Staining Test", we confirmed the subject device was colored, and substantially equivalent to the predicate device and the reference device.
Regarding "Water solubility", the subject device was easily removed from substrate. Also, at "pH (after rinse)", the value of the subject device showed the same value of control which is not apply any devices.
Finally, at "SEM and EDX Surface Comparison", peak area ratio of the subject device is the same as the value of control and the predicate device and reference device.
From the above result, the subject device can be easily rinsed with water.
9
We evaluated the biocompatibility of the subject device according to "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff" and "ISO 10993-1:2018". As a conclusion of biological evaluation, we have concluded that the subject device is substantially equivalent to the reference devices.
10.Conclusion
The comparison for Indication for Use, chemical ingredients and performance data shows that the subject device is substantially equivalent to the predicate device and the reference device.