(40 days)
Not Found
No
The 510(k) summary describes a dental cement and bonding system, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use and device description are purely related to the material properties and application of the cement.
No
The device is described as a cement for dental restorations like crowns, bridges, and veneers, which is used for adhesion purposes rather than directly treating a disease or condition.
No
The device is described as a cement for dental restorations, indicating a therapeutic or restorative purpose rather than a diagnostic one.
No
The device description clearly identifies the product as "CLEARFIL ESTHETIC CEMENT & DC BOND," which are dental cements, not software. The intended uses also describe the application of these physical materials.
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 the cementation of dental restorations and posts. This is a direct application within the body (in vivo) for structural support and bonding, not for testing samples taken from the body (in vitro) to diagnose conditions.
- Device Description: The device is described as "CLEARFIL ESTHETIC CEMENT & DC BOND," which are materials used for dental bonding.
- Lack of IVD Indicators: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Diagnosing diseases or conditions
- Measuring analytes
- Any other activities typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a dental restorative material, not an IVD.
N/A
Intended Use / Indications for Use
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- Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic, hybrid ceramics, composite resin or metal
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- Cementation of veneers
-
- Cementation of adhesion bridges
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- Cementation of metal cores, resin cores, metal posts or glass-fiber posts
Product codes
EMA
Device Description
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
I. INTRODUCTION
ﯿﻮ ﻣﮩﺮ ﺳ
[CLEARFIL ESTHETIC CEMENT & DC BOND, KURARAY MEDICAL INC.] Section 3: Summary
1062410
Aug 16, 2006
510(k) Summary
SEP 26 2006
3-1. 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
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
3-2. Name of Device
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Trade / Proprietary name
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Classification name
-
Common name
3-3. Predicate device
- PANAVIA F 2.0
CLEARFIL ESTHETIC CEMENT & DC BOND
Dental cement (21 CFR section 872.3275. Product code: EMA)
Composite resin cement
510(k) Number: Product Code: 21 CFR Section: Applicant:
K032455 EMA 872.3275 KURARAY MEDICAL INC.
2) CLEARFIL DC CEMENT
510(k) Number: Product Code: 21 CFR Section: Applicant:
K012735 EMA 872.3275 KURARAY MEDICAL INC.
3) CLEARFIL DC CORE AUTOMIX
510(k) Number: Product Code: 21 CFR Section: Applicant:
K043177 EBF 872.3690 KURARAY MEDICAL INC.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. 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
Kuraray Medical, Incorporated C/O Mr. Koji Nishida Kuraray America, Incorporated 600 Lexington Avenue, 26th Floor New York, New York 10022
SEP 2 6 2006
Re: K062410
Trade/Device Name: Clearfil™ Esthetic Cement & DC Bond Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: August 16, 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 Coometic Act (Act) that do not require approval of a premarket approval application (PMA). You may n 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 devines , 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 it (112), 1 be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA meet publish further announcements concerning your device in the Federal Register.
2
Page 2 – Mr. Koji Nishida
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r touse be advisound a determination that your device complies with other requirements of the Act or that Federal statutes and regulations administered by other Federal agencies. You must comply with all 1 castle statution and to got 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 iabeling (2) cregulation (2) 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 devise .in-your.Section 510(k) rms let notification. The FDA finding of substantial equivalence of your device to a legally premated 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 Echedi missimational 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,
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
3
Indications for Use
KO62410 510(k) Number (if known):
Device Name: CLEARFIL ESTHETIC CEMENT & DC BOND
Indications for Use:
-
- Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic, hybrid ceramics, composite resin or metal
-
- Cementation of veneers
-
- Cementation of adhesion bridges
-
- Cementation of metal cores, resin cores, metal posts or glass-fiber posts
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
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)
Sen
Sign-Or
sion of Aneste
meral Hospital,
Jon Control, Deares
Number: 10062410