K-ETCHANT SYRINGE; NEEDLE TIP (E)

K133078 · Kuraray Noritake Dental, Inc. · KLE · Dec 20, 2013 · Dental

Device Facts

• Record ID: K133078
• Device Name: K-ETCHANT SYRINGE; NEEDLE TIP (E)
• Applicant: Kuraray Noritake Dental, Inc.
• Product Code: KLE · Dental
• Decision Date: Dec 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

1. Etching of enamel and dentin 2. Cleaning of dental restorative materials

Device Story

K-ETCHANT Syringe is a dental etching gel consisting of 35% phosphoric acid aqueous solution and colloidal silica. The device is supplied in a polypropylene and polyethylene syringe with a stainless steel (SUS304) and polypropylene nozzle. It is used by dental professionals to apply the etching agent directly to tooth surfaces or dental restorative materials. The flowable consistency allows for precise, selective placement. The device functions by decalcifying enamel and dentin to prepare surfaces for bonding or cleaning. Effectiveness is verified by comparing pH, etching patterns, and tensile bond strength to predicate devices. The device is intended for professional use in a dental clinic.

Clinical Evidence

Bench testing only. Comparative studies against predicate devices evaluated pH, enamel and dentin decalcification patterns, and tensile bond strength of bonding agents to etched tooth surfaces and prosthetic restorations. Results indicated no statistically significant difference (P>0.05) in bond strength performance compared to predicates.

Technological Characteristics

35% phosphoric acid aqueous solution with colloidal silica. Delivery system: polypropylene/polyethylene syringe with stainless steel (SUS304) and polypropylene nozzle. Manual application. No electronic components or software.

Indications for Use

Indicated for the etching of enamel and dentin and the cleaning of dental restorative materials in a clinical dental setting.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Predicate Devices

• K-ETCHANT GEL (K062409)
• UNI ETCH (K101485)
• PANAVIA F 2.0 (K032455)
• CLEARFIL AP-X (K012740)
• CERABIEN ZR (K031968)

Submission Summary (Full Text)

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[K-ETCHANT Syringe, Kuraray Norita Section 3: Summa

> Date: November 12, 2013

## 510(k) Summary

### 3-1. 510(k) owner (submitter)

#### I) Name

2) Address

3) Contact person

4) Contact person in US

Kuraray Noritake Dental Inc.

1621 Sakazu, Kurashiki, Okayama 710-0801, Japan

Michio Takigawa Quality Assurance Department

Goro Asanuma KURARAY AMERICA, INC. 33 Maiden Lane, 6th Floor, New York, NY 10038 Tel: [phone] (Ext. 115) or (800)-879-1676 Fax: [phone]

#### 3-2. Name of Device

1) Trade / Proprietary name

2) Classification name

3) Common name

#### 3-3. Predicate device

2) UNI ETCH

3) PANAVIA F 2.0

4) CLEARFIL AP-X

1) K-ETCHANT GEL

K-ETCHANT Syringe

Resin Tooth Bonding Agent (21 CFR section 872.3200 Product code: KLE)

Phosphoric Acid Gel

510(k) Number:

Classification:

Product Code:

Applicant:

21 CFR Section:

510(k) Number:

Classification:

Product Code:

Applicant:

21 CFR Section:

510(k) Number:

Classification:

Product Code:

Applicant:

21 CFR Section:

510(k) Number:

Classification:

Product Code:

Applicant:

21 CFR Section:

K062409 Tooth Shade Resin Material EBF 872.3690 Kuraray Noritake Dental Inc.

> K101485 Resin Tooth Bonding Agent KLE 872.3200 Bisco, Inc.

K032455 Dental Cement EMA 872.3275 Kuraray Noritake Dental Inc.

K012740 Tooth Shade Resin Material EBF 872.3690 Kuraray Noritake Dental Inc.

5) CERABIEN ZR 510(k) Number: K031968 Classification: Porcelain Powder for clinical use Product Code: EIH 21 CFR Section: 872.6660 Applicant: Kuraray Noritake Dental Inc.

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## 3-4. Device Description

The subject device is an etching gel that consists of 35% phosphoric acid aqueous solution and colloidal silica. It allows for precise and selective placement thanks to its flowable but not runny consistency.

This is the new registration application for the subject device and there have not been any prior submissions regarding the subject device.

This device is filled in a syringe made of polypropylene and polyethylene. The etching agent is applied to tooth surface through a nozzle attached to tip of the syringe. The nozzle is made of polypropylene and stainless steel(SUS304).

## 3-5. Statement of Intended Use

- 1. Etching of enamel and dentin
- 2. Cleaning of dental restorative materials

## 3-6. Substantial Equivalence Discussion

- l) Intended uses
The intended use of the subject device was written up based on that of the predicate devices. Therefore, the intended use of the subject device is substantially equivalent to that of the predicate devices.

- 2) Chemical ingredients/ Safety
The subject device, K-ETCHANT GEL and UNI ETCH contain similar amount of phosphoric acid.

All ingredients in the subject device have been used in the predicate devices. Regarding the predicate devices, there have not been any reported problems or recalls according to the post market adverse event reporting requirements in the US. In conclusion, it can be said that the safety of the subject device is substantially equivalent to that of the predicate devices.

- 3) Technological characteristics/ Effectiveness and Performance
K-ETCHANT GEL, one of the predicate devices, is filled in a bottle, while the subject device is filled in a syringe as the other predicate device. UNI ETCH. The dimension and materials of the subject device's syringe are similar as those of the UNI ETCH's.

Both the subject device and UNI ETCH are directly applied to tooth surface through a nozzle attached to the tip of syringe. On the other hand, K-ETCHANGT GEL is once dispensed to a mixing dish and applied to tooth surface with a small brush.

Since there have not been any international standards concerning performance of this type of device, certain tests were performed on this device considering its intended uses, in comparison with the predicate devices.

The test items and brief description of the results are as follows.

(l) pH:

It was confirmed that the pH value of the subject device was equivalent to those of the predicate devices.

- (2) Enamel and dentin decalcification:
It was confirmed that the etching pattern treated by the subject device was equivalent to those by the predicate devices.

- (3) Tensile bond strength of a bonding agent to tooth surface which was etched: Each tensile bond strength of a bonding agent which had been used after treatment of the subject device was not statistically (P>0.05) different from the corresponding measured value of the predicate device.
- (4) Tensile bond strength of a bonding agent to various prosthetic restorations which were treated by an etching agent:

Each tensile the bond strength of a bonding agent which had been used after treatment of the subject device was not statistically (P>0.05) different from the corresponding measured value of the predicate device.

As the results of the above testings, it was concluded that the effectiveness and performance of the subject device were substantially equivalent to those of the predicate devices. Accordingly, it was concluded that the effectiveness and performance of the subject device

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were substantially equivalent to those of the predicate devices.

#### 3-7. Biocompatibility

The subject device is categorized into the external communicating device that may contact dentin and whose duration of contact is less than 24 hours.

All the chemical ingredients of the subject device are equivalent to those of the predicate devices.

Regarding the predicate devices, there have not been any reported problems or recalls according to the post-market adverse event reporting requirements in the US.

Accordingly, it was considered that the subject device was substantially equivalent in safety to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 20, 2013

Kuraray Noritake Dental Incorporated C/O Mr. Goro Asanuma General Manager Kuraray America, Incorporated 33 Maiden Lane, 6th Floor New York, NY 10038

Re: K133078

Trade/Device Name: K-ETCHANT Syringe Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: November 19, 2013 Received: November 21, 2013

Dear Mr. Asanuma:

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. 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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Page 2 - Mr. Asanuma

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biomctrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.tea.texas.gov/Curriculum*and*Testing/Resources*for*Four*Through*Twelve*Classroom*Instruction.aspx

Sincerely vours.

Image /page/4/Picture/8 description: The image shows the text "Kwame O. Ulmer-S" in a bold, sans-serif font. The text is arranged in two lines, with "Kwame O." on the top line and "Ulmer-S" on the bottom line. Behind the text, there are some geometric shapes, including a circle and a triangle, which appear to be part of a logo or design element.

for

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

K133078 510(k) Number (if known):

Device Name: K-ETCHANT Syringe

Indications for Use:

1. Etching of enamel and dentin

2. Cleaning of dental restorative materials

Prescription Use _ 1 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ N/A (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)

Susan Runner
Mary S. Runner -5
2019
18:15:05'00"