(35 days)
Not Found
No
The document describes a dental adhesion primer and does not mention any AI or ML components or functionalities.
No
The device is an adhesion primer for dental restorations, improving retention of fillings rather than directly treating a disease or condition.
No
The device is described as an adhesion primer used to enhance the bond strength for composite resin restorations, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is an "adhesion primer" containing "dimethacrylate monomer," which are chemical 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 for bonding composite resin restorations to dentin and enamel. This is a dental procedure performed directly on the patient's tooth.
- Device Description: The device is described as an adhesion primer applied to the interior of a prepared tooth cavity to improve retention of a restoration. This is also a direct application to the patient.
- CFR Classification: The device is classified under CFR 21 Section 872.3200, which is for "Adhesion primer" within the Dental Devices category. This classification is for devices used in dental procedures on patients, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The intended use is as follow when this device is used in conjunction with a phosphoric acid etching agent and a bonding agent contained in CLEARFIL PHOTO BOND (K012432)
- A dentin and enamel bonding system for composite resin restoration
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
CLEARFIL SA PRIMER is the adhesion primer to enhance the bond strength to dentine of CLEARFIL PHOT BOND when used in conjunction with it. Therefore this device is classified into Adhesion primer, CFR 21 Section 872.3200, because it is a device containing dimethacrylate monomer intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a composite filling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dentin and enamel of a tooth
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
§ 872.3200 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
7 2002 JUN
[CLEARFIL SA PRIMER, Kuraray Medical Inc.]
510(k) SUMMARY
- Submitter
9
・ジ
KURARAY MEDICAL INC.
| 1) Name * : | KURARAY MEDICAL INC. |
|---|---|
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-8622, Japan |
| 3) Contact person | Koji Nishida |
| Dental Material Department | |
| 4) Date | March , 2001 |
| 5) Contact person in U.S.A. | Masaya Sasaki |
| Kuraray America, Inc. | |
| 101 East 52nd Street, 26th Floor, New York, NY 10022 | |
| Telephone : (212)-986-2230 (Ext.115) | |
| Facsimile : (212)-867-3543 |
2. Name of Device
-
- Proprietary Name CLEARFIL SA PRIMER
| 2) Classification Name | Resin tooth bonding agent (21CFR 872.3200) |
|---|---|
| 3) Common/Usual Name | Adhesion primer |
3. Predicate device:
The predicate devices are as follows.
.
- CLEARFIL LINER BOND SYSTEM by Kuraray Co., Ltd. (K943166) 1.
-
- CLEARFIL PHOTO BOND by Kuraray Medical Inc. (K012432)
-
- Description for the premarket notification
CLEARFIL SA PRIMER is the adhesion primer to enhance the bond strength to dentine of CLEARFIL PHOT BOND when used in conjunction with it. Therefore this device is classified into Adhesion primer, CFR 21 Section 872.3200, because it is a device containing dimethacrylate monomer intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a composite filling.
-
- Statement of the intended use
The intended use is as follow when this device is used in conjunction with a phosphoric acid etching agent and a bonding agent contained in CLEARFIL PHOTO BOND (K012432)
- Statement of the intended use
-
- A dentin and enamel bonding system for composite resin restoration
- Statement of the technological characteristics and safety
6-1. Technological characteristics
This device is a same solution of N-Methacryloy1-5-Aminosalicilic acid and is essentially the same as the adhesion primer, SA PRIMER, of CLEARFIL LINER BOND SYSTEM (K943166). When used in conjunction with CLEARFIL PHOTO BOND (K012432), this device is applied on the etched tooth structures with the phosphoric acid etching agent before application of the bonding agent. In case of CLEARFRIL LINER BOND SYSTEM, the adhesion primer is applied on the etched/conditioned tooth structures with the citric acid-calcium chloride conditioner, CA
1
Agent, before application of the bonding agent which is a component of CLEARFIL PHOTO BOND. Therefore the technological characteristics of this device is substantially same to CLEARFIL LINER BOND SYSTEM (K943166).
6-2. Safety
This device is a same solution of N-Methacryloy1-5-Aminosalicilic acid and is essentially the same as the adhesion primer, SA PRIMER, of CLEARFIL LINER BOND SYSTEM (K943166). Therefore the safety of this device are completely the same as SA PRIMER of CLEARFIL LINER BOND SYSTEM.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
7 2002 JUN
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kuraray Medical, Incorporated C/O Masaya Sasaki Kurarav America, Incorporated 101 East 52nd Street, 26th Floor New York, New York 10022
Re: K021427
Trade/Device Name: CLEARFIL SA PRIMER Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: April 25, 2002 Received: May 03, 2002
Dear Masaya Sasaki:
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 - Masaya Sasaki
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Timothy Ulatowski
Timothy atowski Director Division of Dental. Infection Control. and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
[CLEARFIL SA PRIMER, Kuraray Medical Inc.]
Indications for Use
CLEAFIL SA PRIMER is indicated for the following applications:
- A dentin and enamel bonding system for composite resin restoration ・
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Part 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Susan Rumm
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number _