(52 days)
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No
The document describes a dental cement and its physical properties, with no mention of AI or ML technology.
No
The device is a dental cement used for binding restorations, not for treating or curing a medical condition.
No
The device is a dental cement used for the cementation of various dental restorations. Its intended use is for bonding, not for diagnosing any medical condition or disease.
No
The device description clearly states it is a "dual-cure (light- and/or self-cure), radiopaque self-adhesive resin cement" supplied in an "automix delivery system." This describes a physical material and a delivery mechanism, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a cement for bonding dental restorations (crowns, bridges, etc.) to teeth or implant abutments. This is a direct application within the body (in vivo), not a test performed on samples taken from the body (in vitro).
- Device Description: The description confirms it's a resin cement used for bonding.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information. The performance studies focus on physical and mechanical properties relevant to its function as a cement.
Therefore, this device falls under the category of a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- (1) Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic, composite resin or metal
- (2) Cementation of porcelain, ceramic, composite resin or metal restorations on implant abutments
- (3) Cementation of metal cores, resin cores, metal posts or glass fiber posts
Product codes
EMA
Device Description
PANAVIA SA CEMENT Automix is a dual-cure (light- and/or self-cure), radiopaque self-adhesive resin cement for porcelain, ceramic, composite resin and metal restorations. It is supplied in an automix delivery system which can mix equal amount of two components. It is intended for the following indications:
- (1) Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic, composite resin or metal
- (2) Cementation of porcelain, ceramic, composite resin or metal restorations on implant abutments
- (3) Cementation of metal cores, resin cores, metal posts or glass fiber posts
-
- It is classified into dental cement (21 CFR section 872,3275, Product code: EMA ) according to 21 CFR8872 since it is composed of various materials other than zinc oxide-eugenol.
-
- Physical and mechanical properties of the subject device were evaluated according to ISO 4049: 2009 (Dentistry - Polymer-based restorative and materials). According to ISO 4049: 2009, the subject device is classified into the following:
- Class 3: materials that are cured by the application of external energy and also have a self-curing mechanism present
(This product contains the adhesive monomer. ISO 4049:2009 does not cover the polymer-based luting materials that have an adhesive component within the structure of the material. However, we tested referring to this standard.)
Mentions image processing
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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
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Key Metrics
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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.
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Image /page/0/Picture/0 description: The image shows the date March 30, 2012, written in the bottom left corner. Above the date, there is a handwritten number that appears to be K120379. The number is written in a cursive style, and the letters and numbers are connected. The image is a close-up of the date and number, and the background is white.
[PANAVIA SA CEMENT Automix, KURARAY MEDICAL INC.] Section 3: Summary
ને
January 31, 2012 Date:
3-1. 510(k) owner (submitter)
- Name
_T
-
Address
-
Contact person
-
Contact person in U.S.
KURARAY MEDICAL INC.
510(k) Summary
1621 Sakazu, Kurashiki, Okayama 710-0801, Japan
Michio Takigawa Quality Assurance Department
Kiyoyuki Arikawa 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
-
Trade / Proprietary name
-
Classification name
-
Čonin si nislo
3-3. Predicate device
-
CLEARFIL SA CEMENT
-
RelyX Unicem 2
3) PANAVIA F 2.0
PANAVIA SA CEMENT Automix
Dental cement (21 CFR section 872.3275. Product code: EMA)
bumal a interve rerin comoni
510(k) Number: K081583 Product Code: EMA 21 CFR Section: 872. 3275 Applicant: KURARAY MEDICAL INC.
510(k) Number: K100756 Product Code: EMA 21 CFR Section: 872. 3275 Applicant: 3M ESPE AG DENTAL PRODUCTS
510(k) Number: K032455 Product Code: EMA 21 CFR Section: 872.3275 Applicant: KURARAY MEDICAL INC.
1
3-4. Device Description
- PANAVIA SA CEMENT Automix is a dual-cure (light- and/or self-cure), radiopaque self-adhesive resin cement for porcelain, ceramic, composite resin and metal restorations. It is supplied in an automix delivery system which can mix equal amount of two components. It is intended for the following indications:
- (1) Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic, composite resin or metal
- (2) Cementation of porcelain, ceramic, composite resin or metal restorations on implant abutments
- (3) Cementation of metal cores, resin cores, metal posts or glass fiber posts
-
- It is classified into dental cement (21 CFR section 872,3275, Product code: EMA ) according to 21 CFR8872 since it is composed of various materials other than zinc oxide-eugenol.
-
- Physical and mechanical properties of the subject device were evaluated according to ISO 4049: 2009 (Dentistry - Polymer-based restorative and materials). According to ISO 4049: 2009, the subject device is classified into the following:
- Class 3: materials that are cured by the application of external energy and also have a self-curing mechanism present
(This product contains the adhesive monomer. ISO 4049:2009 does not cover the polymer-based luting materials that have an adhesive component within the structure of the material. However, we tested referring to this standard.)
3-5. Substantial Equivalence Discussion
1) Intended uses
The INDICATIONS of the subject device were written up based on those of the predicate devices. Therefore, the intended purposes of the subject device are substantially the same as those of the predicate ones.
2) Chemical ingredients / Safety
All chemical ingredients of PANAVIA SA CEMENT Automix are the same as those of the predicate device, CLEARFIL SA CEMENT.
Regarding the prediente device, there have not heen any reported problems or recolls incording to the wost-market adverse event reporting requirements in U.S.
Therefore, we have concluded that the safety of the subject device can be guaranteed.
3) Effectiveness / Performance
PANAVIA SA CEMENT Automix complies with all requirements of ISO 4049: 2009 as polymer-based restorative materials.
And also, the bond strength of the subject device is equivalent to that of the predicate devices. Therefore, it can be said that its effectiveness has also been proved.
3-6. Biocompatibility
All the chemical ingredients of the subject device, PANAVIA SA CEMENT Automix, are the same as those of the predicate device, CLEARFIL SA CEMENT, as shown on the tables of "7-4 Chemical ingredients": in "Section 7: Substantial Equivalence Discussion".
Regarding the predicate devices, there have not been any reported problems or recalls according to the post- market adverse event reporting requirements in U.S.
Therefore, we have concluded that the biological safety of the subject device can be guaranteed.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains an image of an eagle with three lines representing its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Mr. Michio Takigawa Manager KURARAY MEDICAL Incorporation Ote Center Bldg. 7F, 1-1-3, Otemachi Chiyoda-ku Japan 100-0004
MAR 3 0 2012
Re: K120379
Trade/Device Name: PANAVIA SA CEMENT Automix Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: January 31, 2012 Received: February 8, 2012
Dear Mr. Takigawa:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
Page 2 - Mr. Takigawa
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: PANAVIA SA CEMENT Automix
Indications for Use:
- [1] Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic, composite resin or metal
- [2] Cementation of porcelain, ceramic, composite resin or metal restorations on implant abutments
- [3] Cementation of metal cores, resin cores, metal posts or glass fiber posts
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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)
Susan Ranner
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devicess
510(k) Number: K120329
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