(37 days)
No
The document describes a dental cement and its intended uses, which are standard applications for this type of material. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device description focuses on the material composition and classification as a dental cement.
No
The device is a dental cement used for the physical attachment of dental restorations, which is not considered a therapeutic function.
No
Explanation: The device is a dental cement used for the permanent attachment of dental prosthetics. It does not perform any diagnostic functions like detecting, monitoring, or predicting diseases.
No
The device description explicitly states it is a dental cement composed of materials like dimethacrylate monomers and inorganic fillers, indicating it is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that PANAVIA F is a dental cement used for bonding various dental restorations (crowns, bridges, inlays, etc.) to teeth. This is a direct application within the mouth for structural support and restoration.
- Device Description: The device description classifies it as a "dental cement" under CFR 21 Section 872.3275. This classification is for devices used in the mouth for dental procedures.
- Lack of IVD Characteristics: An IVD is a device used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or interaction with bodily specimens for diagnostic purposes.
Therefore, PANAVIA F is a dental device used for restorative procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended uses of this device are as follows. They are completely the same as PANAVIA F manufactured by Kuraray Co., Ltd. (K002322).
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- Cementation of metal crowns and bridges, inlays and onlays
PANAVIA F is indicated for the following applications:
- Cementation of metal crowns and bridges, inlays and onlays.
- Cementation of porcelain crowns, inlays, onlays and veneers.
- Cementation of composite resin crowns, inlays and onlays
- Cementation of adhesion bridges and splints
- Cementation of metal cores and prefabrication posts
- Bonded amalgam restorations
Product codes
EMA
Device Description
PANAVIA F is classified into dental cement, CFR 21 Section 872.3275, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers intended to be used for cementation of dental devices such as crown and bridges.
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
Dental Material Department Chome, Umeda, Kita-ku, Osaka 530-8611, JAPAN : +81-6-348-2603 Facsimile: +81-6-348-2552
ARAY MEDIC
Image /page/0/Picture/3 description: The image shows a sequence of handwritten alphanumeric characters. The characters are 'K012441', and they appear to be written with a thick marker or pen, giving them a bold appearance. The characters are slightly slanted to the right.
SEP - 6 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 | July 23, 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 | PANAVIA F |
|---|---|
| 2) Classification Name | Dental Cement (21 CFR 872.3275) |
| 3) Common/Usual Name | Dental Adhesive |
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 The aim of 510(k) submission is to alter the name and address of October 1st 2001. manufacturer, and not to intend other changes.
The predicate device is as follow.
- (K002322) PANAVIA F by Kuraray Co., Ltd. 1.
-
- Description for the premarket notification
PANAVIA F is classified into dental cement, CFR 21 Section 872.3275, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers intended to be used for cementation of dental devices such as crown and bridges.
5. Statement of the intended use
The intended uses of this device are as follows. They are completely the same as PANAVIA F manufactured by Kuraray Co., Ltd. (K002322).
-
- Cementation of metal crowns and bridges, inlays and onlays
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 symbol resembling three human profiles or faces, stacked on top of each other, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 6 2001
Kuraray Medical Incorporated C/O Ms. Masaya Sasaki Kuraray America, Incorporated 30th Floor Metlife Building 200 Park Avenue New York, New York 10166
Re: K012441
Trade/Device Name: Panavia F Regulation Number: 872.3275 Regulation Name: Dental Adhesive Regulatory Class: II Product Code: EMA Dated: July 23, 2001 Received: July 31, 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
2
Page 2 - Ms. Sasaki
of the Act or any Federal statutes and regulations administered by other Federal agencies. or the rece or any - outh all the Act's requirements, including, but not limited to: registration r ou into confirst (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 premiurner level 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,
Timothy A. Ullatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
[PANAVIA F, Kuraray Medical Inc.]
Image /page/3/Picture/1 description: The image shows a sequence of handwritten characters. The characters are K, O, 1, 2, 4, 4, and 1. The characters are written in black ink on a white background. The characters appear to be a code or serial number.
510(k) Number (if known):
Device Name: PANAVIA F
: "
Indications for Use
PANAVIA F is indicated for the following applications:
- Cementation of metal crowns and bridges, inlays and onlays. 1)
- Cementation of porcelain crowns, inlays, onlays and veneers. 2)
- Cementation of composite resin crowns, inlays and onlays 3)
- Cementation of adhesion bridges and splints 4)
- Cementation of metal cores and prefabrication posts 5)
-
- Bonded amalgam restorations
(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_
Susan Runna
(Optional Format 1-2-96)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number _