(45 days)
Not Found
No
The device description and performance studies focus on the material properties and safety of a polymer-based dental restorative material, with no mention of AI or ML.
No
The device is a polymer-based material used for fabricating and repairing prosthetic dental appliances, not for treating a disease or condition.
No
The device description and intended use clearly state that this device is a polymer-based material used for fabricating and repairing prosthetic dental appliances. It is a restorative material, not a device designed to identify or diagnose diseases or conditions.
No
The device description clearly states it is a "polymer based material," indicating it is a physical substance used for fabricating dental prosthetics, 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 the device is used for fabricating and repairing dental prosthetic appliances (crowns, bridges, inlays, onlays). This is a restorative dental application, not a diagnostic one.
- Device Description: The description confirms it's a polymer-based material for creating physical dental prosthetics.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
- Performance Studies: The performance studies focus on physical and mechanical properties based on ISO standards relevant to dental materials, not diagnostic accuracy metrics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
ESTENIA C&B is indicated for the following applications for the restoring crowns and defects.
-
- Facing cast crowns and facing cast bridges
-
- Jacket crowns
-
- Inlays and onlays
- Bridges with frameworks 4)
Product codes
EBF and EBG
Device Description
This device is a polymer based material, used for fabricating prosthetic appliance such as facing cast crowns, facing cast bridges, jacket crowns, inlays, onlays or bridges with frameworks, and for repair of those prosthetic appliances made of resin based crown and bridge materials or porcelain.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
(K012707)
(K033267)
(K012737)
(K992645)
(K962878)
(K954115)
(K972292)
(K020131)
(K964578)
DEC - 6 2004
510(k) SUMMARY
| 1) Name | KURARAY MEDICAL INC. |
|---|---|
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-8622, Japan |
| 3) Contact person | Masaya Sasaki |
| Dental Material Division | |
| 4) Date | October 18, 2004 |
| 5) Contact person in U.S.A. | Koji Nishida |
| Kuraray America, Inc. | |
| 101 East 52nd Street, 26th Floor, New York, NY 10022 | |
| Telephone: (212)-986-2230 (Ext.115) | |
| Facsimile: (212)-867-3543 |
-
- Name of Device
- Submitter
| 1) Proprietary Name | ESTENIA C&B |
|---|---|
| 2) Classification Name | Tooth shade resin material (21CFR 872.3690) |
| 3) Common/Usual Name | Polymer-based crown and bridge material |
3. Predicate device:
The predicate products are;
a) Tooth shade resin material
-
- ESTENIA
-
- EPRICORD
-
- CHROMA ZONE COLOR STAIN
-
- SINFONY
-
- TARGIS SYSTEM
-
- ARTGLASS & KEVLOC
-
- SOLIDEX
-
- VENUS UNIVERSAL LIGHT CURING COMPOSITE
-
- FIBREKOR
b) Other dental materials
-
SPECIALTIES, INC.
by Kuraray Medical Inc.
by Kuraray Medical Inc.
by Kuraray Medical Inc.
by IVOCLAR NORTH AMERICA,
by HERAEUS KULZER, INC.
by HERAEUS KULZER, INC.
by JENERIC/PENTRON, INC.
by SHOFU DENTAL CORP.
by ESPE DENTAL AG
1
4. Device description and intended use
This device is a polymer based material, used for fabricating prosthetic appliance such as facing cast crowns, facing cast bridges, jacket crowns, inlays, onlays or bridges with frameworks, and for repair of those prosthetic appliances made of resin based crown and bridge materials or porcelain.
5. Statement of the technological characteristics and safety
Chemical ingredients, design, physical and mechanical properties, and safety are same as predicate devices in the USA.
The physical and mechanical properties of ESTENIA C&B are verified by evaluation test based on ISO 10477. Safety is also verified because all chemical ingredients are used in legally marketed predicate devices.
Therefore this device is safe, effective, and substantially equivalent with predicated devices.
2
Image /page/2/Picture/11 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles a stylized caduceus, with a staff and a serpent winding around it. The emblem is black, and the text is also black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 6 2004
Kuraray Medical, Incorporated C/O Ms. Koji Nishida Kuraray America, Incorporated 101 East 52nd Street, 26th Floor New York, New York 10022
Re: K042929
Trade/Device Names: Estenia™ C&B Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF and EBG Dated: October 18, 2004 Received: October 27, 2004
Dear Ms. Nishida:
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
Page 2 - Ms. Koji Nishida
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 (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.
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 (240) 276-0115. 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 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,
Chiu S. Lin, PhD
Director
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
[ESTENIA C&B, Kuraray Medical Inc.]
1104 2929
Indications for Use
ESTENIA C&B is indicated for the following applications for the restoring crowns and defects.
-
- Facing cast crowns and facing cast bridges
-
- Jacket crowns
-
- Inlays and onlays
- Bridges with frameworks 4)
(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)
Kein Miley for MSP
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: