(163 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a dental cement, with no mention of AI or ML.
No.
The device is a resin cement used for bonding dental restorations, which is a restorative rather than a therapeutic function.
No
The device description and intended use indicate it is a self-adhesive resin cement used for bonding dental restorations, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is a "dual-cure... self-adhesive resin cement," which is a physical material, not software. The performance studies also focus on physical and mechanical properties of the material.
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 prosthetics within the mouth. This is a direct application on a patient for a therapeutic or restorative purpose.
- Device Description: The description details a dental cement used for bonding materials together.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., to gain information about a person's health status. This device is a material used in a dental procedure.
N/A
Intended Use / Indications for Use
[1] Cementation of crowns, bridges, inlays and onlays
[2] Cementation of prosthetic restorations on implant abutments and frames
[3] Cementation of adhesion bridges and splints
[4] Cementation of posts and cores
[5] Amalgam bonding
Product codes
EMA
Device Description
The subject device is a dual-cure (light- and/or self-cure), fluoride releasing, radiopaque self-adhesive resin cement for ceramic (porcelain, lithium disilicate, zirconia, etc.), composite resin, and metal restorations.
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
Physical and mechanical properties of the subject device were evaluated according to ISO 4049: 2009 (Dentistry - Polymer-based restorative and materials).
The results indicate that the subject device and the predicate device comply with the requirements of ISO 4049: 2009.
Tensile bond strength to bovine dentin was evaluated in accordance with ISO/TS 11405: 2003. It was confirmed that there were no statistically (p>0.05) significant differences between the subject device and the predicate device.
Shear bond strength to the implant abutment was evaluated in accordance with ISO/TS 11405: 2003. It was confirmed that there were no statistically (p>0.05) significant differences between the subject device and the predicate device.
Released fluorine ion test was performed to validate the substantial equivalence of the subject device with the predicate device in terms of effectiveness and performance for the intended uses. It was concluded that amount of released fluorine ion from the subject device is substantially equivalent to those from the predicate device.
Key Metrics
Not Found
Predicate Device(s)
K120378, K032455, K012740, K042913, K111982
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26,2015
Kuraray Noritake Dental, Inc. Michio Takigawa Manager Ote Center Bldg. 7f, 1-1-3, Otemachi Chiyoda Ku. Tokyo 100-0004 Japan
Re: K142623
Trade/Device Name: Panavia SA Cement Plus Handmix Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: January 23, 2015 Received: January 26, 2015
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.
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Susan Russo DDS, MA
Erin Keith Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
Device Name: PANAVIA SA Cement Plus Handmix
Indications for Use:
[1] Cementation of crowns, bridges, inlays and onlays
[2] Cementation of prosthetic restorations on implant abutments and frames
[3] Cementation of adhesion bridges and splints
[4] Cementation of posts and cores
[5] Amalgam bonding
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
3
[PANAVIA SA Cement Plus Handmix, Kuraray Noritake Dental Inc.] Section 3: Summary
February 25 ,2015 Date:
510(k) Summary
3-1. 510(k) owner (submitter)
| 1) | Name | Kuraray Noritake Dental Inc. | |
|---|---|---|---|
| 2) | Address | 1621 Sakazu, Kurashiki, Okayama 710-0801, Japan | |
| 3) | Contact person | Michio Takigawa | |
| Quality Assurance Department | |||
| 4) | Contact person in US | Goro Asanuma | |
| KURARAY AMERICA, INC. | |||
| 33 Maiden Lane, 6th Floor, New York, NY 10038 | |||
| Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676 | |||
| Fax: (212)-867-3543 | |||
| 3-2. Name of Device | |||
| 1) Trade / Proprietary name | PANAVIA SA Cement Plus Handmix | ||
| 2) Classification name | Dental cement | ||
| (21 CFR section 872.3275. Product code: EMA) | |||
| 3) Common name | Dental adhesive resin cement | ||
| 3-3. Predicate devices | |||
| 1) | PANAVIA SA CEMENT Handmix | 510(k) Number: | |
| Classification: | |||
| Product Code: | |||
| 21 CFR Section: | |||
| Applicant: | K120378 | ||
| Dental cement | |||
| EMA | |||
| 872.3275 | |||
| Kuraray Noritake Dental Inc. | |||
| 2) | PANAVIA F 2.0 | 510(k) Number: | |
| Classification: | |||
| Product Code: | |||
| 21 CFR Section: | |||
| Applicant: | K032455 | ||
| Dental cement | |||
| EMA | |||
| 872.3275 | |||
| Kuraray Noritake Dental Inc. | |||
| 3) | CLEARFIL AP-X | 510(k) Number: | |
| Classification: | |||
| Product Code: | |||
| 21 CFR Section: | |||
| Applicant: | K012740 | ||
| Tooth shade resin material | |||
| EBF | |||
| 872.3690 | |||
| Kuraray Noritake Dental Inc. | |||
| 4) | CLEARFIL TRI-S BOND | 510(k) Number: | |
| Classification: | |||
| Product Code: | |||
| 21 CFR Section: | |||
| Applicant: | K042913 | ||
| Resin tooth bonding agent | |||
| KLE | |||
| 872.3200 | |||
| Kuraray Noritake Dental Inc. | |||
| 5) | CLEARFIL DC CORE PLUS | 510(k) Number: | |
| Classification: | |||
| Product Code: | |||
| 21 CFR Section: | |||
| Applicant: | K111982 | ||
| Tooth shade resin material | |||
| EBF | |||
| 872.3690 | |||
| Kuraray Noritake Dental Inc. |
4
3-4. Device Description
The subject device is a dual-cure (light- and/or self-cure), fluoride releasing, radiopaque self-adhesive resin cement for ceramic (porcelain, lithium disilicate, zirconia, etc.), composite resin, and metal restorations.
This is the new registration application for the subject device and there have not been any prior submissions regarding the subject device.
3-5. Statement of Intended Use
The subject device is indicated for the following uses:
- [1] Cementation of crowns, bridges, inlays and onlays
- [2] Cementation of prosthetic restorations on implant abutments and frames
- [3] Cementation of adhesion bridges and splints
- [4] Cementation of posts and cores
- [5] Amalgam bonding
3-6. Substantial Equivalence Discussion
1) Intended uses
The INDICATIONS of the subject device and predicate devices, PANAVIA SA CEMENT Handmix which is self-adhesive resin cement and PANAVIA F2.0 which is dental resin cement, are as listed on the following table.
| Trade name | Intended use | |
|---|---|---|
| Subject | ||
| device | PANAVIA SA Cement | |
| Plus Handmix | [1] Cementation of crowns, bridges, inlays and onlays | |
| [2] Cementation of prosthetic restorations on implant abutments and frames | ||
| [3] Cementation of adhesion bridges and splints | ||
| [4] Cementation of posts and cores | ||
| [5] Amalgam bonding | ||
| Predicate | ||
| devices | PANAVIA SA | |
| CEMENT Handmix | [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 | ||
| PANAVIA F2.0 | [1] Cementation of metal crowns and bridges, inlays and onlays | |
| [2] Cementation of porcelain crowns, inlays, onlays and veneers | ||
| [3] Cementation of composite resin crowns, inlays, and onlays | ||
| [4] Cementation of adhesion bridges | ||
| [5] Cementation of endodontic cores and prefabricated posts | ||
| [6] Amalgam bonding |
The intended use of the subject device was written up based on those of the predicate devices. Therefore, the intended use of the subject device is substantially equivalent to those of the predicate devices.
- Chemical ingredients/ Safety
Except for 5 chemical ingredients, all ingredients in the subject device have been used in the predicate devices. Regarding the predicate devices, there have not been any reported problems or recalls according to the post market adverse event reporting requirements in the US.
The subject device contains new 5 ingredients. Therefore, we evaluated the subject device referring to ISO 10993 series and ISO 7405. As a result of the tests, it was concluded that the subject device is substantially equivalent in biological safety to the predicate device.
- Technological characteristics/ Effectiveness and Performance
Physical and mechanical properties of the subject device were evaluated according to ISO 4049: 2009 (Dentistry - Polymer-based restorative and materials).
5
| | | PANAVIA SA Cement Plus Handmix
(Subject device) | | PANAVIA SA CEMENT Handmix
(Predicate device) | |
|-------------------------------------------------------------|----------------|----------------------------------------------------|-----------------------|-------------------------------------------------|-----------------------|
| Section | | Shade type:
Universal,
Translucent | Shade type :
White | Shade type:
Universal (A2) | Shade type :
White |
| 5.2.2 Film thickness, luting materials | | COMPLIES | COMPLIES | COMPLIES | COMPLIES |
| 5.2.4 Working time, Class 1 and Class 3
luting materials | | COMPLIES | COMPLIES | COMPLIES | COMPLIES |
| 5.2.6 Setting time, Class 3 materials | | COMPLIES | COMPLIES | COMPLIES | COMPLIES |
| 5.2.9 Flexural strength | | COMPLIES | COMPLIES | COMPLIES | COMPLIES |
| 5.2.10
Water sorption and | Water sorption | COMPLIES | COMPLIES | COMPLIES | COMPLIES |
| solubility | Solubility | COMPLIES | COMPLIES | COMPLIES | COMPLIES |
| 5.4 Color stability after irradiation and
water sorption | | COMPLIES | COMPLIES | COMPLIES | COMPLIES |
| 5.5 Radio-opacity | | COMPLIES | COMPLIES | COMPLIES | COMPLIES |
The results of comparative study performed according to ISO 4049: 2009 were indicated below
The results indicate that the subject device and the predicate device comply with the requirements of ISO 4049: 2009. From the above, it can be said that comparative study of the subject device is substantially equivalent to that of the predicate device.
Tensile bond strength to bovine dentin was evaluated in accordance with ISO/TS 11405: 2003. The result of the subject device is shown on the following table.
| Adherend | Criteria | PANAVIA SA Cement Plus
Handmix (Subject device) | PANAVIA SA CEMENT
Handmix (Predicate device) |
|------------------|-------------------|----------------------------------------------------|-------------------------------------------------|
| Bovine
dentin | In-house standard | COMPLIES | COMPLIES |
It was confirmed that there were no statistically (p>0.05) significant differences between the subject device and the predicate device.
Therefore, it was concluded that tensile bond strength to bovine dentine of the subject device is substantially equivalent to that of the predicate device.
Shear bond strength to the implant abutment was evaluated in accordance with ISO/TS 11405: 2003. The result of the subject device is shown on the following table.
| Adherend | Criteria | PANAVIA SA Cement Plus
Handmix (Subject device) | PANAVIA SA CEMENT
Handmix (Predicate device) |
|-----------|-------------------|----------------------------------------------------|-------------------------------------------------|
| Titan 100 | In-house standard | COMPLIES | COMPLIES |
It was confirmed that there were no statistically (p>0.05) significant differences between the subject device and the predicate device.
Therefore, it was concluded that shear bond strength to the implant abutment of the subject device is substantially equivalent to that of the predicate device
Released fluorine ion test was performed to validate the substantial equivalence of the subject device with the predicate device in terms of effectiveness and performance for the intended uses. It was concluded that amount of released fluorine ion from the subject device is substantially equivalent to those from the predicate device.
3-7. Biocompatibility
The subject device is classified according to ISO 7405:2008 and ISO 10993-1:2009 as an external communicating device that will have permanent (> 30 days) contact with tissues. We performed the biological safety tests of PANAVIA SA Cement Plus Automix which is a similar composition. As a result of the tests, it was concluded that the subject device is substantially equivalent in biological safety to the predicate device.
3-8. Conclusion
The comparison for intended uses, chemical ingredients/ safety and performance data shows that the subject device is substantially equivalent to the predicate devices.
This submission information including the nonclinical testing provided supports that the subject device is as safe and as effective as the predicate devices.