(46 days)
No
The summary describes a dental restorative material and does not mention any AI or ML components or functionalities.
No
The device, CLEARFIL AP-X PLT, is described as a "Tooth shade Resin Material" used to restore carious or structural defects in teeth. It is a restorative material, not a device designed to treat, prevent, or diagnose a disease or condition in a therapeutic manner.
No
Explanation: The device is a restorative material for dental cavities and defects, not a tool for diagnosis. Its intended use is to restore teeth, not to identify or analyze medical conditions.
No
The device description explicitly states it is composed of materials like bisphenol A glycidylmethacrylate (Bis-GMA), which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that CLEARFIL AP-X PLT is a "Tooth shade Resin Material" intended to "restore carious or structural defects in teeth." This is a material used directly on the patient's teeth, not for testing specimens outside the body.
- Intended Use: The intended uses are all related to restoring teeth, which is a direct treatment on the patient.
Therefore, based on the provided information, CLEARFIL AP-X PLT is a dental restorative material, not an IVD.
N/A
Intended Use / Indications for Use
CLEARFIL AP-X PLT is indicated for the following applications:
- Class I, II, V restorations of posterior teeth
- Class III, IV, V restorations of anterior teeth
- Cervical cavities or defects involving root surfaces
Product codes
EBF
Device Description
This product is classified into Tooth shade Resin Material, CFR 29 Section 872.3690, because it is a device composed of materials such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to restore carious or structural defects in teeth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth (posterior teeth, anterior teeth, cervical cavities or defects involving root surfaces)
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OCT 2 5 2002
[CLEARFIL AP-X
Image /page/0/Picture/3 description: The image is a black and white logo for Kuraray. The logo features a stylized letter "K" that is also shaped like a square. Below the symbol is the word "KURARAY" in a bold, sans-serif font.
KURARAY MEDICAL INC.
Dental Material Department 3-1-6 Nihonbashi, Chuo-ku, Tokyo 103-8254, Japan Tel : +81.3.3277.6949 Fax : +81.3.3277.6956
510(k) SUMMARY
| 1. Submitter | |
|---|---|
| 1) Name | KURARAY MEDICAL INC. |
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-8622, Japan |
| 3) 1. Contact person | Koji Nishida |
| Dental Material Department, Kuraray Medical Inc. |
Masaya Sasaki 2. Contact person in U.S.A. Kuraray America Inc. 101 East 52nd Street, 26th Floor New York, NY 10022 Telephone : (212)-986-2230 (Ext.115) 1-(800)-879-1676 Facsimile : (212)-867-3543 4) Date August 25, 2002
2. Name of Device
| 1) Proprietary Name | CLEARFIL AP-X PLT |
|---|---|
| 2) Classification Name | Tooth shade resin material (21CFR 872.3690) |
| 3) Common/Usual Name | Composite resin restorative |
-
- Predicate device:
The predicate device is as follow.
- Predicate device:
- CLEARFIL AP-X by Kuraray Medical Inc. (K012740)
-
- Description for the premarket notification
This product is classified into Tooth shade Resin Material, CFR 29 Section 872.3690, because it is a device composed of materials such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to restore carious or structural defects in teeth.
- Description for the premarket notification
5. Statement of the intended use
The intended uses of this device are as follows. They are the same as CLEARFIL AP-X manufactured by Kuraray Medical Inc. (K012740).
- Class I, II, V restorations of posterior teeth 1)
- Class III, IV, V restorations of anterior teeth 2)
-
- Cervical cavities or defects involving root surfaces
- Statement of the technological characteristics and safety
This device is substantially same to CLEARFIL AP-X manufactured by Kuraray Medical Inc. (K012740). Therefore CLEARFIL AP-X and CLEARFIL AP-X PLT are substantially equivalent on the technological characteristics, chemical ingredients and safety.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
OCT 2 5 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kuraray Medical, Incorporated C/O Ms. Masaya Sasaki Kuraray America, Incorporated 101 East 52nd Street, 26th Floor New York, New York 10022
Re: K023002
Trade/Device Name: CLEARFIL AP-X PLT Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth-Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 04, 2002 Received: September 09, 2002
Dear Ms. 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.
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.
2
Page 2 - Ms. Masaya Sasaki
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 A. Ulatowski
Timot Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
KO23002 510(k) Number (if known): .
Device Name: CLEARFIL AP-X PLT
Indications for Use
CLEARFIL AP-X PLT is indicated for the following applications:
- Class I, II, V restorations of posterior teeth
-
- Class III, IV, V restorations of anterior teeth
- Cervical cavities or defects involving root surfaces
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use______________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
La Aulhuts
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number ._