(43 days)
No
The summary describes a chemical bonding agent and its performance characteristics, with no mention of AI or ML.
No.
The device is a bonding system used to promote adhesion of restorative material to tooth structures, indicated for restorative procedures like core build-ups, direct restorations, and cavity sealing, rather than for treating or curing a disease or condition.
No
The device is a bonding system used for restorative procedures in dentistry, not for diagnosing medical conditions. Its intended uses involve promoting adhesion of restorative materials, not identifying diseases or conditions.
No
The device description clearly states it is a "two-component, one-step bonding system" composed of "materials such as dimethacrylate monomers," 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 uses listed are all related to dental procedures performed directly on a patient's teeth (core build-ups, direct restorations, cavity sealing, treatment of exposed root surfaces, intraoral repairs). These are clinical procedures, not laboratory tests performed on samples taken from the body.
- Device Description: The device is described as a "Resin tooth bonding agent" intended to promote adhesion of restorative material to tooth structures. This is a material used in a clinical setting for treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's health status. The performance studies focus on physical properties like bond strength and microleakage, which are relevant to the device's function in a dental restoration, not to a diagnostic test.
Therefore, CLEARFIL DC BOND is a dental device used for restorative procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
CLEARFIL DC BOND, the applicant device, is intended to be used for the indications listed in the left hand column of the below table that are equivalent to those of the predicate devices.
- Core build-ups using light-, dual-, or self-cure composite resin
- Direct restorations using light-cure composite resin
- Direct restorations using self-cure composite resin
- Cavity sealing as a pretreatment for indirect restorations
- Treatment of exposed root surfaces
- 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
Device Description
CLEARFIL DC BOND is a dual-cure (light- and /or self-cure), two-component, one-step bonding system that allows simultaneous treatment of both dentin and enamel. It is classified into Resin tooth bonding agent, 21 CFR Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to promote adhesion of restorative material to dentin, enamel, and metal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dentin, enamel
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 and marginal sealing characteristic (microleakage) tests performed on the applicant device have demonstrated that the applicant device is more effective and performs 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.
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.
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
§ 872.3200 Resin tooth bonding agent.
(a)
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.(b)
Classification. Class II.
0
Kuraray
SEP 27 2006
August 14, 2006 Date:
Brown .. Jesper .. Jeven ... ..
510(k) Summary
- 510(k) owner (submitter)
-
Name
-
Address
-
Contact person
-
Contact person in U.S.
KURARAY MEDICAL INC.
1621 Sakazu, Kurashiki, Okayama 710-0801, Japan
Michio Takigawa Quality Assurance Department
CLEARFIL DC BOND
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
- Name of Device
-
Trade / Proprietary name
-
Classification name
Resin tooth bonding agent (21 CFR section 872.3200. Product code: KLE)
Resin-based dental adhesive system
- Common name
- Predicate device
| 1) CLEARFIL TRI-S BOND | 510(k) Number:
Product Code:
21 CFR Section:
Applicant: | K042913
KLE
872.3200
KURARAY MEDICAL INC. |
|---------------------------|------------------------------------------------------------------|----------------------------------------------------|
| 2) CLEARFIL LINER BOND 2V | 510(k) Number:
Product Code:
21 CFR Section:
Applicant: | K012440
KLE
872.3200
KURARAY MEDICAL INC. |
| 3) CLEARFIL PHOTO BOND | 510(k) Number:
Product Code:
21 CFR Section:
Applicant: | K012432
KLE
872.3200
KURARAY MEDICAL INC. |
- Description of device
CLEARFIL DC BOND is a dual-cure (light- and /or self-cure), two-component, one-step bonding system that allows simultaneous treatment of both dentin and enamel. It is classified into Resin tooth bonding agent, 21 CFR Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to promote adhesion of restorative material to dentin, enamel, and metal.
1
5. Intended use of device
CLEARFIL DC BOND, the applicant device, is intended to be used for the indications listed in the left hand column of the below table that are equivalent to those of the predicate devices.
| Table 3-1: Indications for Use and predicate devices | |
|---|---|
| ------------------------------------------------------ | -- |
| Indications for Use | Predicate devices |
|---|---|
| 1) Core build-ups using light-, dual-, or self-cure composite resin | CLEARFIL LINER BOND 2V |
| (in conjunction with CLEARFIL DC CORE AUTOMIX*) | |
| 2) Direct restorations using light-cure composite resin | CLEARFIL TRI-S BOND, |
| CLEARFIL PHOTO BOND | |
| CLEARFIL LINER BOND 2V | |
| 3) Direct restorations using self-cure composite resin | CLEARFIL LINER BOND 2V |
| 4) Cavity sealing as a pretreatment for indirect restorations | CLEARFIL TRI-S BOND, |
| CLEARFIL LINER BOND 2V | |
| 5) Treatment of exposed root surfaces | CLEARFIL TRI-S BOND, |
| CLEARFIL LINER BOND 2V | |
| 6) Intraoral repairs of fractured crowns/bridges made of porcelain, ceramics, hybrid ceramics or composite resin | CLEARFIL TRI-S BOND, |
| CLEARFIL LINER BOND 2V |
- CLEARFIL DC CORE AUTOMIX: K043177, manufactured by KURARAY MEDICAL INC. CLEARFIL DC CORE AUTOMIX is intended to be used for core build-ups and is indicating the use of CLEARFIL LINER BOND 2V in its Instructions for Use.
- Technological characteristics of device
It can be said that CLEARFIL DC BOND, the applicant device, is as safe and 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 and marginal sealing characteristic (microleakage) tests performed on the applicant device have demonstrated that the applicant device is more effective and performs better than the predicate devices.
- Effectiveness / Performance
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 7 2006
Kuraray Medical, Incorporated C/O Mr. Koji Nishida Kuraray America, Incorporated 600 Lexington Avenue, 26th Floor New York, New York 10022
Re: K062382
Trade/Device Name: Clearfil™ DC Bond Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: August 14, 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. Koji 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" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clus
Chiu S. Lin. PhD 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
061382 510(k) Number (if known):
Device Name: _CLEARFIL DC BOND
Indications for Use:
:: 1) Core build-ups using light-, dual-, or self-cure composite resin
-
Direct restorations using light-cure composite resin
-
Direct restorations using self-cure composite resin
-
Cavity sealing as a pretreatment for indirect restorations
-
Treatment of exposed root surfaces
-
Intraoral repairs of fractured crowns/bridges made of porcelain, ceramics, hybrid ceramics or composite resin
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (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 Burns
n of Anesthesiology, General Hospital, on Control. Dental De
: Number K062352