(36 days)
Not Found
No
The 510(k) summary describes a dental cement and does not mention any AI or ML capabilities.
No
This device is a dental cement used to fix dental prostheses, not to treat a disease or condition.
No
This device is a dental cement used to affix dental devices, not for diagnosing medical conditions.
No
The device description explicitly states it is composed of materials such as dimethacrylate monomers, indicating it is a physical substance (dental cement) and 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 within the mouth (in vivo). IVDs are used to examine specimens from the human body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states it's a dental cement used to affix dental devices. This aligns with a dental restorative material, not an IVD.
- Classification: The classification provided, "Dental cement other than zinc oxide-eugenol, CFR 29 Section 872.3275," is a classification for dental devices, not IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical characteristics associated with IVDs.
Therefore, this device is a dental cement intended for use in the mouth, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
PANAVIA 21 is indicated for the following applications:
- Cementation of adhesion bridges or splints
- Cementation of metal crowns, bridges and inlays/onlays
- Cementation of silanated porcelain and cured composite crowns or inlays/onlays
- Cementation of preformed posts or cast post and cores
- Bonded amalgam restoratios
Product codes
EMA
Device Description
This product is a device composed of materials such as dimethaclylate monomers intended to affix dental devices such as crowns or bridges. It is classified into Dental cement other than zinc oxide-eugenol, CFR 29 Section 872.3275.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
PANAVIA 21 by Kuraray Co., Ltd. (K933030)
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
SEP - 5 2001
[PANAVIA 21, Kuraray Medical Inc.]
Image /page/0/Picture/2 description: The image shows a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the letter 'O', then the number '1', the number '2', the number '4', the number '3', and ends with the number '8'. The characters are written in a bold, sans-serif font.
Image /page/0/Picture/3 description: The image is a logo for Kuraray. The logo is a black square with a white "K" and "G" inside. The word "KURARAY" is written in white letters below the square. The logo is simple and modern.
39, 1-Chome, Umeda, Kita-ku, Osaka 530-8611, JAPAN e- +81-6-348-2552
RARAY MEDICAL INC.
510(k) SUMMARY
1. Submitter
-
Name
-
Date
-
Address
KURARAY MEDICAL INC. 1621 Sakazu, Kurashiki, Okayama 710-8622, Japan Koji Nishida 3) Contact person DENTAL MATERIAL DEPARTMENT July 23, 2001 Masaya Sasaki 5) Contact person in U.S.A. 30th Fl. Metlife Building, 200 Park Avenue, New York,
Facsimile : (212)-867-3543
1(800)-879-1676
Telephone : (212)-986-2230
- Name of Device
| 1) Proprietary Name | PANAVIA 21 |
|---|---|
| 2) Classification Name | Dental Cement (21 CFR 872.3275) |
| 3) Common/Usual Name | Dental Adhesive |
NY 10166
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.
PANAVIA 21 by Kuraray Co., Ltd. 1.
(K933030)
- Description for the premarket notification
This product is a device composed of materials such as dimethaclylate monomers intended to affix dental devices such as crowns or bridges. It is classified into Dental cement other than zinc oxide-eugenol, CFR 29 Section 872.3275. Hereby it is reasonable to submit the premarket notification.
1
- Statement of the intended use
The intended uses of this device are as follows. They are completely the same as PANAVIA 21 manufactured by Kuraray Co., Ltd. (K933030).
- Cementation of adhesion bridges or splints 1)
- Cementation of metal crowns, bridges and inlays/onlays 2)
- Cementation of silanated porcelain and cured composite crowns or inlays/onlays 3)
- Cementation of preformed posts or cast post and cores 4)
-
- Bonded amalgam restoratios
-
- Statement of the technological characteristics and safety
This device is essentially the same as PANAVIA 21 manufactured by Kuraray Co., td. (K933030). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as PANAVIA 21.
2
Image /page/2/Picture/1 description: The image contains a cropped portion of text. The text says "T OF HEALTH &" in a bold, sans-serif font. The text is black against a white background.
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol featuring a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
SEP = 5 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 : K012438 Modification To Panavia 21 Trade/Device Name: 872.3275 Regulation Number: Requlatory Class: II Product Code: EMA July 23, 2001 Dated: Received: July 31, 2001
Dear Ms. Sasaki:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.
3
Page 2 - Ms. Sasaki
concerning your device in the Federal Register. Please note: this response to your premarket notification submission does chis response to your pro you might have under sections 531 not arreet any obsignt for devices under the Electronic cirough 542 OF the not of other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your alence of your device to a legally marketed predicate device results in a classification for your marketed predicate actre your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in regaracter ( Compliance at (301) 594-4613. Additionally, for questions on compramotion 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, Obtained From Cho 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 Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
[PANAVIA 21, Kuraray Medical Inc.]
K012438
510(k) Number (if known): K012438
Device Name: PANAVIA 21
Indications for Use
PANAVIA 21 is indicated for the following applications:
-
Cementation of adhesion bridges or splints
-
Cementation of metal crowns, bridges and inlays/onlays
-
Cementation of silanated porcelain and cured composite crowns or inlays/onlays
-
Cementation of preformed posts or cast post and cores
-
Bonded amalgam restoratios
(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 Runge
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number .