(85 days)
Not Found
No
The summary describes a chemical primer for dental materials and contains no mention of AI or ML.
No.
The device description and intended use indicate it is an adhesive agent used for surface treatment and repairs of dental materials, not for treating a disease or condition in a patient.
No
The device, CLEARFIL CERAMIC PRIMER, is a silane-coupling agent used for surface treatment and repair of dental materials, enhancing adhesion. Its intended use and description do not involve detection, diagnosis, or assessment of diseases or conditions.
No
The device description clearly states it is a "silane-coupling agent," which is a chemical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are for surface treatment and intraoral repairs of dental materials (porcelain, ceramics, hybrid ceramics, composite resin). These are procedures performed directly on or in the patient's mouth, not on samples taken from the body for diagnostic purposes.
- Device Description: The device is described as a silane-coupling agent that enhances adhesion to dental materials. This is a material used in dental procedures, not a test or reagent used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnosing a disease or condition, or providing information about a patient's health status based on in vitro testing.
The device is clearly intended for use in dental restorative procedures, which are not considered in vitro diagnostics.
N/A
Intended Use / Indications for Use
-
- Surface treatment of porcelain, ceramics, hybrid ceramics or composite resin
-
- Intraoral repairs of fractured crowns/bridges made of porcelain, ceramics, hybrid ceramics or composite resin
Product codes (comma separated list FDA assigned to the subject device)
KLE, EBF
Device Description
CLEARFIL CERAMIC PRIMER is a silane-coupling agent that provides an enhanced adhesive surface to porcelain, ceramics, hybrid ceramics or composite resin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Tensile bond strength tests on the applicant device in comparison to the predicate devices Tellshe bond sheight tests on the appass effective and performs as well as or better than the predicate 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.
K012730, K012442, K042913, K905220
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
[CLEARFIL CERAMIC PRIMER, KURARAY MEDICAL INC.]
Section 3: Summary
Image /page/0/Picture/1 description: The image is a logo for Kuraray. The logo is a black square with a white stylized letter "K" inside. The word "KURARAY" is printed in white letters below the square. The logo is simple and modern.
JRARAY MEDICAL. INC.
Quality Assurance Department
1-1-3 Otemachi, Chiyoda-ku, Tokyo, 100-0000 : +81-(0)3-6701-1706 Phone Facsimile: +81-(0)3-6701-1805
SEP 2 8 2006
Date: June 30, 2006
510(k) Summary
3-1. 510(k) owner (submitter)
-
- Name
-
Address
-
Contact person
-
Contact person in U.S.
1604.0 K 1141.0 710.0
1621 Sakazu, Kurashiki, Okayama 710-0801, Japan
Michio Tukigawa Quality Assurance Department
KURARAY MEDICAL INC.
Koji Nishida KURARAY AMERICA INC. 101 East 52nd Street, 26th Floor New York, NY 10022 Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676 Fax: (212)-867-3543
3-2. Name of Device
- Classification name
CLEARFIL CERAMIC PRIMER 1) Trade / Proprietary name
Resin tooth bonding agent (21 CFF): section 872.3200. Product code: KLE)
Silane coupling agent
3-3. Predicate device
-
Common name
-
CLEARFIL PORCELAIN 510(k) Number: K012730 Product Code: BOND ACTIVATOR KLE 21 CFR Section: 872.3200 Applicant: KURARAY MEDICAL INC. 2) CLEARFIL SE BOND 510(k) Number: K012442 Product Code: KLE 872.3200 21 CFR. Section: Applicant: KURARAY AMERICA, INC. 510(k) Number: K042913 3) CLEARFIL TRI-S BOND Product Code: KLE 21 CFR Section: 872.3200 Applicant: KURARAY COMPANY, LTD. 510(k) |Number: K905220 4) MONOBOND S Product Code: EBF 21 CFR Section: 872.3690 IVOCLAR NORTH AMERICA, INC. Applicant:
1
3-4. Description of device
CLEARFIL CERAMIC PRIMER is a silane-coupling agent that provides an enhanced adhesive surface to porcelain, ceramics, hybrid ceramics or composite resin.
at is intended to be used for the indications listed in the right hand column of the below table that are equivalent to the predicate devices.
Table 3: Indications for Use and predicate devices
| Indications for Use | Predicate devices |
|---|---|
| 1) Surface treatment of porcelain, | |
| ceramics, hybrid ceramics or composite | |
| resin | - MONOBOND S |
- CLEARFIL SE BOND (not indicating ceramics)
- CLEARFIL TRI-S BOND and CLEARFIL
PORCELAIN BOND ACTIVATOR (not
indicating ceramics or hybrid ceramics) |
| 2) Intraoral repairs of fractured
crowns/bridges made of porcelain,
ceramics, hybrid ceramics or composite
resin | - MONOBOND S - CLEARFIL SE BOND (not indicating ceramics)
- CLEARFIL TRI-S BOND and CLEARFIL
PORCELAIN BOND ACTIVATOR (not
indicating ceramics or hybrid ceramics) |
3-5. Technological characteristics of device
It can be said that the applicant device is as safe as, as effective, and performs as well as or better than the predicate devices with the followings:
-
- Chemical ingredients
All the chemical ingredients of the applicant device have been used in the predicate devices indicating that the safety of the applicant device is substantially equivalent to the predicate devices.
- Chemical ingredients
-
- Effectiveness / Performance
Tensile bond strength tests on the applicant device in comparison to the predicate devices Tellshe bond sheight tests on the appass effective and performs as well as or better than the predicate devices.
- Effectiveness / Performance
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 8 2006
Kuraray Medical, Incorporated C/O Mr. Koji Nishida General Manager Kuraray America, Incorporated 101 East 52nd Street, 26th Floor New York, New York 10022
Re: K061906
Trade/Device Name: Clearfil Ceramic Primer Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: EBF Dated: June 30, 2006 Received: July 11, 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 cither 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.
Snette Y. Michum Omd.
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
$661906 510(k) Number (if known):
Device Name: ________________________________________________________________________________________________________________________________________________________________
Indications for Use:
-
- Surface treatment of porcelain, ceramics, hybrid ceramics or composite resin
-
- Intraoral repairs of fractured crowns/bridges made of porcelain, ceramics,
hybrid ceramics or composite resin
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X AND/C) R (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
nesthesiology. General Hospital. Control. Dental E