(83 days)
Not Found
No
The summary describes a chemical etching agent and makes no mention of AI or ML.
No
The device is described as an etching agent used for adhesive restorations, classified as a resin tooth bonding agent. Its purpose is to prepare the tooth surface for better retention of a restoration, not to treat or cure a disease or condition.
No
The device is an etching agent used to prepare a tooth cavity for restoration, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a gel composed of phosphoric acid and colloidal silica, which are physical substances, 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 "Etching the enamel and dentine for adhesive restorations." This is a procedure performed directly on a patient's tooth, not on a sample taken from the body for diagnostic purposes.
- Device Description: The description clearly states it's an "etching agent" and is classified as a "resin tooth bonding agent." It's intended to be applied to the tooth cavity to improve restoration retention. This is a therapeutic/restorative function, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing diagnostic information.
Therefore, K-ETCHANT GEL is a dental device used for a restorative procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Etching the enamel and dentine for adhesive restorations.
Product codes (comma separated list FDA assigned to the subject device)
KLE, EBF
Device Description
K-ETCHANT GEL is an etching agent consists of 40 % phosphoric acid aqueous solution and colloidal silica. It is classified into resin tooth honding agent, 21 CFR Section 872.3200, because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth / 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)
Not Found
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.
Not Found
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
§ 872.3690 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
uraray
Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The characters appear to be 'K062409'. The writing is in black ink on a white background. The characters are somewhat stylized and have a slightly irregular appearance.
August 16, 2006 Date:
510(k) Summar
NOV - 8 2006
- 510(k) owner (submitter)
| 1) Name | KURARAY MEDICAL INC. | |
|---|---|---|
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-0801, Japan | |
| 3) Contact person | Michio Takigawa | |
| Quality Assurance Department | ||
| 4) Contact person in U.S. | Koji Nishida | |
| KURARAY AMERICA, INC. | ||
| 600 Lexington Avenue, 26th Floor | ||
| New York, NY 10022 | ||
| Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676 | ||
| Fax: (212)-867-3543 | ||
| 2. Name of Device | ||
| 1) Trade / Proprietary name | K-ETCHANT GEL | |
| 2) Classification name | Resin tooth bonding agent |
Resin tooth bonding agent (21 CFR section 872.3200. Product code: KLE)
- Common narne
Etching, agent
- Predicate device
The aim of this submission is to market K-ETCHANT GEL, which has been one of the components in CLEARFIL PHOTO BOND, independently as a single device "K-ETCHANT GEL".
| 1) CLEARFIL PHOTO BOND | 510(k) Number: | K943165
K012432 (modification) |
|------------------------------|------------------------------------------------------------------|----------------------------------------------------|
| | Product Code:
21 CFR Section:
Applicant: | KLE
872.3200
KURARAY MEDICAL INC. |
| 2) PULPDENT ETCH-RITE ROYALE | 510(k) Number:
Product Code:
21 CFR Section:
Applicant: | K031915
KLE
872.3200
PULPDENT CORPORATION |
- Description of device
K-ETCHANT GEL is an etching agent consists of 40 % phosphoric acid aqueous solution and colloidal silica. It is classified into resin tooth honding agent, 21 CFR Section 872.3200, because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration.
-
- Intended use
K-ETCHANT GEL is intended to be used for the following indication;
- Intended use
-
Etching the enamel and dentine for adhesive restorations
1
6. Substantial equivalence
K-ETCHANT GEL has been one of the components in, and will be marketed independently as a single device "K-ETCHATN GEL" from CLEANFIL PHOTO BOND. The applicant device, is essentially the same as K-ETCHANT GEL in CLEARFIL PHOTO BOND that its safety and effectiveness are substantially equivalent to this predicate device. It shares the same intended use with other legally marketed devices of this kind marketed single item such as PULPDENT ETCH-RITE ROYALE.
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kuraray Medical, Incorporated C/O Mr. Koji Nishida General Manager Kuraray America, Incorporated 600 Lexington Avenue, 26th Floor New York, New York 10022
NOV -8 2006
Re: K062409
Trade/Device Name: K-ETCHANT GEL Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: August 16, 2006 Received: August 24, 2006
Dear Mr. Nishida:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 -Mr. Nishida
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ر
Device Name: K-ETCHANT GEL
Indications for Use:
- Etching the enamel and dentine for adhesive restorations.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/CPR (Part 21 CFR 801 Subpart D)
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
(Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control. D
510(k) Number: K062409