(31 days)
Not Found
No
The document describes a dental cement and does not mention any AI or ML capabilities.
No
The device is a dental cement used to affix dental appliances, which is restorative and not primarily therapeutic in nature. Its classification under 21 CFR 872.3275 as "dental cement other than zinc oxide-eugenol" further supports its restorative application.
No
Explanation: The device is a dental cement used to affix dental appliances. It does not perform any diagnostic function.
No
The device description explicitly states it is a "dual-cure composite resin cement," which is a physical material, 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 listed are for cementing dental appliances (inlays, crowns) within the mouth. This is a direct application to the patient's body, not for testing samples taken from the body.
- Device Description: The description clearly states it's a "dual-cure composite resin cement and used as a cement to affix dental appliances." This reinforces its function as a material used in dental procedures on a patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information based on in vitro testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for affixing dental restorations.
N/A
Intended Use / Indications for Use
CLEARFIL DC CEMENT is indicated for the following applications:
- Porcelain inlay cementation
- Composite resin inlay cementation
- Jacket crown cementation with porcelain or composite resin
Product codes
EMA
Device Description
CLEARFIL DC CEMENT is a dual-cure composite resin cement and used as a cement to affix dental appliances such as crowns. This product is classified into the dental cement other than zinc oxide-eugenol, 21 C.F.R. Section 872.3275.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image is a black and white logo for Kuraray. The logo features a stylized letter "K" that is enclosed in a square. The word "KURARAY" is written in block letters below the symbol.
DICAL INC. URARAY MEL
Dental Material Department 12-39, 1-Chome, Umeda, Kita-ku, Osaka 530-8611, JAPAN : +81-6-348-2603 Phone Facsimile: +81-6-348-2552
KOI2735
SEP 1 4 2001
510(k) SUMMARY
| 1. Submitter | |
|---|---|
| 1) Name | KURARAY MEDICAL INC. |
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-8622, Japan |
| 3) Contact person | Koji Nishida |
| DENTAL MATERIAL DEPARTMENT | |
| 4) Date | August 9, 2001 |
| 5) Contact person in U.S.A. | Masaya Sasaki |
| 30th Fl. Metlife Building, 200 Park Avenue, New York, | |
| NY 10166 | |
| Telephone : (212)-986-2230 | |
| 1-(800)-879-1676 | |
| Facsimile : (212)-867-3543 |
2. Name of Device
| 1) Proprietary Name | CLEARFIL DC CEMENT |
|---|---|
| 2) Classification Name | Dental cement (21 C.F.R. Section 872.3275) |
| 3) Common/Usual Name | Composite resin cement |
3. Predicate device:
Kuraray Co., Ltd. will transfer the medical device business and the relevant functions including manufacturing facilities to its subsidiary company named Kuraray Medical Inc. on October 1st 2001. The aim of 510(k) submission is to alter the name and address of manufacturer, and not to intend other changes.
The predicate device is as follow.
(K980232) CLEARFIL DC CEMENT by Kuraray Co., Ltd. 1.
4. Description for the premarket notification
CLEARFIL DC CEMENT is a dual-cure composite resin cement and used as a cement to This product is classified into the dental cement affix dental appliances such as crowns. other than zinc oxide-eugenol, 21 C.F.R. Section 872.3275.
5. Statement of the intended use
The intended uses of this device are as follows. They are completely the same as CLEARFIL DC CEMENT manufactured by Kuraray Co., Ltd. (K980232).
- 1)Porcelain inlay cementation
-
- Composite resin inlay cementation
1
3)Jacket crown cementation with porcelain or composite resin
6. Statement of the technological characteristics and safety
.
This device is essentially the same as CLEARFIL DC CEMENT manufactured by Kuraray Co., Ltd. (K980232). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL DC CEMENT.
:
2
Image /page/2/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.
Public Health Service
SEP 1 4 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kuraray Medical Incorporated C/O Ms. Masaya Sasaki Kuraray America, Incorporated 30th Floor Metlife Building 200 Park Avenue New York, New York 10166
Re: K012735
Trade/Device Name: Clearfil DC Cement Regulation Number: 872.3275 Regulation Name: Composite Resin Cement Regulatory Class: II Product Code: EMA Dated: August 9, 2001 Received: August 14, 2001
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.
3
Page 2 - Ms. 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 (section 531-542 of the Act; 21); CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your 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 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 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,
U. Adalbert
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Device Name: CLEARFIL DC CEMENT
Indications for Use
CLEARFIL DC CEMENT is indicated for the following applications:
- Porcelain inlay cementation 1)
- Composite resin inlay cementation 2)
- Jacket crown cementation with porcelain or composite resin 3)
(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)
Susan Runne
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .