(68 days)
K#980051, K#051808
K#980051, K#051808
No
The 510(k) summary describes a dental composite resin material and its physical properties, with no mention of software, algorithms, image processing, or AI/ML terms.
No
The device is a composite resin system used for dental restorations, which acts as a material to restore tooth structure rather than directly treating a disease or therapeutic condition. Its function is restorative and cosmetic.
No
The device is described as a "tooth shade resin material" for use in "dental procedures such as anterior and posterior restorations," indicating it is a restorative material, not a diagnostic one.
No
The device is described as a "tooth shade resin material," which is a physical substance used in dental procedures, 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 it's a "tooth shade resin material for use in dental procedures" for restorations, veneers, etc. This describes a material used directly on the patient's tooth for structural and aesthetic purposes.
- Lack of In Vitro Testing: The description of the device and performance studies focuses on material properties like flexural strength, water sorption, solubility, and depth of cure. These are tests performed on the material itself, not on biological samples outside the body to diagnose or monitor a condition.
- Anatomical Site: The anatomical site is "tooth," which is part of the living body. IVDs typically analyze samples taken from the body (blood, urine, tissue, etc.).
- No Mention of Diagnosis or Monitoring: The intended use does not mention diagnosing, monitoring, or screening for any disease or condition.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The E-1 ESTHETIC COMPOSITE SYSTEM tooth shade resin material is a light-cured, radiopaque, submicron-filled composite resin system for use in dental procedures such as anterior and posterior restorations including occlusal surfaces, direct bonded composite veneers, diastema closures, and the repair of porcelain/composites.
Product codes
EBF
Device Description
The E-1 ESTHETIC COMPOSITE SYSTEM device is substantially equivalent to multiple predicate devices (K#980051 and K#051808) with respect to flexural strength, water sorption, solubility, and depth of cure for various curing times. Although the E-1 ESTHETIC COMPOSITE SYSTEM device may have slightly different performance characteristics than the predicate devices, these differences do not raise new questions of safety or effectiveness. All ingredients used in the E-1 ESTHETIC COMPOSITE SYSTEM are biocompatible, as demonstrated by their common use in similar dental devices such as the predicate devices identified above.
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)
K#980051, K#051808
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K07 2746
510(k) SUMMARY Tokuyama Dental Corporation E-1 ESTHETIC COMPOSITE SYSTEM
Name of Device
DEC 0 4 2007
| Trade or Proprietary Name: | E-1 ESTHETIC COMPOSITE SYSTEM |
|---|---|
| Common Name: | tooth shade resin material |
| Classification Name: | material, tooth shade, resin |
| Product Code: | EBF |
Preparation Date
September 12, 2007
510(k) Sponsor
Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo 110-0016 Japan
510(k) Sponsor Contact
Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331
Intended Use
The E-1 ESTHETIC COMPOSITE SYSTEM tooth shade resin material is a light-cured, radiopaque, submicron-filled composite resin system for use in dental procedures such as anterior and posterior restorations including occlusal surfaces, direct bonded composite veneers, diastema closures, and the repair of porcelain/composites.
1
Technological Characteristics and Substantial Equivalence
The E-1 ESTHETIC COMPOSITE SYSTEM device is substantially equivalent to multiple predicate devices (K#980051 and K#051808) with respect to flexural strength, water sorption, solubility, and depth of cure for various curing times. Although the E-1 ESTHETIC COMPOSITE SYSTEM device may have slightly different performance characteristics than the predicate devices, these differences do not raise new questions of safety or effectiveness. All ingredients used in the E-1 ESTHETIC COMPOSITE SYSTEM are biocompatible, as demonstrated by their common use in similar dental devices such as the predicate devices identified above.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is a symbol of medicine and health, often associated with healthcare organizations.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 4 2007
Tokuyama Dental Corporation C/O Mr. Keith A. Barritt, Esq. Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, District of Columbia 20005
Re: K072746
Trade/Device Name: E-1 Esthetic Composite System Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 26, 2007 Received: October 2, 2007
Dear Mr. Barritt:
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- Mr. Barritt
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 vour 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/industry/support/index.html.
Sincerely yours.
Sutte y. Michie o
m.D.
Chiu Lin, Ph.D. 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): unknown K072746
Device Name: E-1 ESTHETIC COMPOSITE SYSTEM
Indications for Use:
The E-1 ESTHETIC COMPOSITE SYSTEM is for use as a tooth shade resin material in dental procedures.
Prescription Use (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)
Susan Thomas
Apostleship, Government,
of Daniel Davis.
KO72741
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