(30 days)
Not Found
No
The summary describes a dental resin material for restorations and does not mention any software, algorithms, or AI/ML capabilities.
No
The document describes ESTENIA as a tooth shade resin material used for laboratory fabrication of dental restorations (jacket crown, facing crown, inlay, and onlay), not as a device for direct therapeutic treatment of a disease or condition.
No
The device description states that ESTENIA is a "tooth shade resin material...intended to be used for laboratory fabrication of jacket crown, inlay and onlay restorations." This indicates it is a material used for restoration, not for diagnosing medical conditions.
No
The device description explicitly states it is a "tooth shade resin material" composed of physical materials, not software.
Based on the provided information, this device, ESTENIA, is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the laboratory fabrication of dental restorations (jacket crowns, facing crowns, inlay, and onlay). This is a direct application to the patient's tooth structure, not a test performed on a sample taken from the body.
- Device Description: The description clearly states it's a "tooth shade resin material" used for "laboratory fabrication of jacket crown, inlay and onlay restorations." This aligns with a dental restorative material, not a diagnostic test.
- Classification: It is classified under CFR 21 Section 872.3690, which is for "Tooth shade resin material." This is a classification for dental materials, not IVDs.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Providing information about a disease or condition
- Using reagents or assays
Therefore, ESTENIA is a dental restorative material used in a laboratory setting, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ESTENIA is used for the following cases:
-
- Jacket crown
-
- Facing crown
-
- Inlay and onlay
Product codes
EBF
Device Description
ESTENIA is classified into tooth shade resin material, CFR 21 Section 872.3690, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers intended to be used for laboratory fabrication of jacket crown, inlay and onlay restorations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth
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
SEP 1 3 2001
Image /page/0/Picture/2 description: The image shows a sequence of alphanumeric characters, specifically 'KO12707'. The characters are written in a clear, sans-serif font, with a consistent stroke width. The text appears to be a code or identifier, possibly a serial number or product code.
Image /page/0/Picture/3 description: The image is a logo for Kuraray. The logo is a black square with a white stylized letter "K" inside. The word "KURARAY" is written in white letters below the "K" inside the black square.
Dental Material Department 12-39, 1-Chome, Umeda, Kita-ku, Osaka 530-8611, JAPAN : +81-6-348-2603 Phone Facsimile: +81-6-348-2552
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 | Koji Nishida |
| DENTAL MATERIAL DEPARTMENT | |
| 4) Date | August 9, 2001 |
| 5) Contact person in U.S.A. | Masaya Sasaki |
| 30th Fl. Metlife Building, 200 Park Avenue, New York | |
| NY 10166 | |
| Telephone : (212)-986-2230 | |
| 1-(800)-879-1676 | |
| Facsimile : (212)-867-3543 |
2. Name of Device
| 1) Proprietary Name | ESTENIA |
|---|---|
| 2) Classification Name | Tooth shade resin material (21CFR 872.3690) |
| 3) Common/Usual Name | Resin-based crown and bridge material |
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.
- (K982164) ESTENIA by Kuraray Co., Ltd. 1.
-
- Description for the premarket notification
ESTENIA is classified into tooth shade resin material, CFR 21 Section 872.3690, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers intended to be used for laboratory fabrication of jacket crown, inlay and onlay restorations.
-
- Statement of the intended use
The intended uses of this device are as follows. They are completely the same as ESTENIA manufactured by Kuraray Co., Ltd. (K982164).
- Statement of the intended use
ESTENIA is used for the following cases:
- 1)Jacket crown
- Facing crown
1
3) Inlay and onlay
-
- Statement of the technological characteristics and safety
This device is essentially the same as ESTENIA manufactured by Kuraray Co., Ltd. Therefore the technological characteristics, chemical ingredients and safety of (K982164). this device are completely the same as ESTENIA.
- Statement of the technological characteristics and safety
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 3 2001
Kuraray Medical Incorporated C/O Ms. Masaya Sasaki Kuraray America, Incorporated 30th Floor Metlife Building 200 Park Avenue New York, New York 10166
Re: K012707
Trade/Device Name: Estenia Regulation Number: 872.3690 Regulation Name: Resin-Based Crown and Bridge Material Regulatory Class: II Product Code: EBF Dated: August 9, 2001 Received: August 14, 2001
Dear Ms. Sasaki:
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.
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
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Page 2 - Ms. Sasaki
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 (section 531-542 of the Act; 21); CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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 807.97). 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,
[signature]
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
[ESTENIA, Kuraray Medical Inc. ]
Image /page/4/Picture/1 description: The image shows a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the digit '0', then the digit '1', then the digit '2', then the digit '7', then the digit '0', and ends with the digit '7'. The characters are written in a simple, clear style, and they appear to be part of a larger document or label.
510(k) Number (if known):
Device Name: ESTENIA
Indications for Use
ESTENIA is used for the following cases:
Jacket crown 1)
Facing crown 2)
- Inlay and onlay
(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 Runore
(Division Sign-Off) (Division of Dental, Infection Control, and General Hospital Devices
510(k) Number____________________________________________________________________________________________________________________________________