(88 days)
No
The document describes a dental cement and its physical properties and performance, with no mention of AI or ML.
No
The device is a dental cement used for bonding dental devices, not for treating diseases or conditions.
No
This device is a dental cement used for bonding various dental restorations, not for diagnosing medical conditions. Its intended uses are cementation and bonding, which are treatment-oriented applications.
No
The device description explicitly states it is a "dental cement" composed of materials like monomers and fillers, which are physical substances, not software.
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 devices (crowns, bridges, inlays, onlays, veneers, posts, amalgam bonding). These are procedures performed directly on a patient's teeth or in the mouth.
- Device Description: The device is described as a dental cement used for cementation of dental devices. This aligns with its intended use as a material for dental restoration and bonding.
- CFR Classification: The device is classified under CFR 21 Section 872.3275, which is for dental cement. This classification is for devices used in the mouth for dental purposes, not for in vitro diagnostic testing.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) outside of the body to diagnose a disease or condition. The performance studies focus on the physical properties of the cement (curing times, depth of cure, etc.), not on diagnostic accuracy.
In summary, the device's function and classification clearly indicate it is a dental material used for restorative procedures, not for in vitro diagnostic testing.
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 Medical Inc. (K012441).
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- Cementation of metal crowns and bridges, inlays and onlays
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- Cementation of porcelain crowns, inlays, onlays and veneers
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- Cementation of composite resin crowns, inlays and onlays
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- Cementation of adhesion bridges
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- Cementation of endodontic cores and prefabricated posts
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- Amalgam bonding
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
PANAVIA F 2.0 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Technological characteristics:
This device is improved from PANAVIA F and complies with the requirement of ISO 4049:2000. The light curing times of this device was assigned according to the type of dental curing lights. Depth of cure, thickness of surface unpolymerized layer, and sensitivity to ambient light were measured and form the result of these tests, light curing properties of this device are superior to PANAVIA F.
Safety: All the ingredients of this device have been used the predicate devices, PANAVIA F and CLEARFIL SE BOND. Therefore the safety of this device is substantially equivalent to the predicate devices.
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.
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
§ 872.3275 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
NOV = 7 2003
[PANAVIA F 2.0, Kuraray Medical Inc.]
510(k) SUMMARY
| 1. Submitter | |
|---|---|
| 1) Name | KURARAY MEDICAL INC. |
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-8622, Japan |
| 3) Contact person | Masaya Sasaki |
| Dental Material Division | |
| 4) Date | August 8, 2003 |
| 5) Contact person in U.S.A. | Satoshi Yamaguchi |
| 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
| 1) Proprietary Name | PANAVIA F 2.0 |
|---|---|
| 2) Classification Name | Dental Cement (21CFR 872.3200) |
| 3) Common/Usual Name | Dental Adhesive |
3. Predicate device:
The predicate devices are as follows.
| 1. | PANAVIA F | by Kuraray Medical Inc. | (K012432) |
|---|---|---|---|
| 2. | CLEARFIL SE BOND | by Kuraray Medical Inc. | (K012442) |
4. Description for the premarket notification
PANAVIA F 2.0 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 Medical Inc. (K012441).
-
- 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
-
- Cementation of endodontic cores and prefabricated posts
-
- Amalgam bonding
6. Statement of the technological characteristics and safety
- 6-1. Technological characteristics
This device is improved from PANAVIA F and complies with the requirement of ISO 4049:2000. The light curing times of this device was assigned according to the type of dental curing lights. Depth of cure, thickness of surface unpolymerized layer, and sensitivity to ambient light were measured and form the result of these tests, light curing properties of this
1
device are superior to PANAVIA F.
6-2. Safety
All the ingredients of this device have been used the predicate devices, PANAVIA F and CLEARFIL SE BOND. Therefore the safety of this device is substantially equivalent to the predicate devices.
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2
Image /page/2/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 representing its body and wings. The eagle is enclosed within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 2003
Kuraray Medical, Incorporated C/O Mr. Satoshi Yamaguchi Marketing Manager Kuraray America. Incorporated 101 East 52nd Street, 26th Floor New York, New York 10022
Re: K032455
Trade/Device Name: Panavia™ F 2.0 Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: October 31, 2003 Received: October 31, 2003
Dear Mr. Yamaguchi:
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
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). 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) you may obtain. 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.
Susa Runoe
Q. Chi-S. Lin, Ph.D.
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
4
(Premarket Notification [510(k)] Number) 510(k) Number (if known):
14032455
Device Name: PANAVIA F 2.0
Indications for Use
PANAVIA F 2.0 is indicated for the following applications:
- Cementation of metal crowns and bridges, inlays and onlays. 1)
-
- Cementation of porcelain crowns, inlays, onlays and veneers.
-
- Cementation of composite resin crowns, inlays and onlays
- Cementation of adhesion bridges 4)
-
- Cementation of endodontic cores and prefabricated posts
-
- Amalgam bonding
(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)
Susa Rums
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: