(77 days)
K#980051, K#051808
K#980051, K#051808
No
The device description and intended use clearly describe a dental composite resin material, with no mention of software, algorithms, or any technology that would incorporate AI or ML. The comparison to predicate devices focuses on material properties and curing time.
No
This device is a submicron-filled composite resin used in dental procedures for restorations, which is a material used for treatment rather than a therapeutic device that delivers therapy or treatment directly.
No
The text describes a composite resin used for dental restorations, not a device that diagnoses conditions.
No
The device is a composite resin material, which is a physical substance used in dental procedures, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "anterior and posterior restorations" and "use as a tooth shade resin in dental procedures." This describes a material used directly on the patient's teeth for restorative purposes.
- Device Description: The description confirms it's a "light cured, radiopaque, submicron-filled composite resin" for "anterior and posterior restorations." This is a material used in dental procedures, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a restorative material used directly in the mouth.
N/A
Intended Use / Indications for Use
ESTELITE SIGMA QUICK is is a light cured, radiopaque, submicron-filled composite resin for use in anterior and posterior restorations and is indicated for all carious classes.
For use as a tooth shade resin in dental procedures.
Product codes
EBF
Device Description
ESTELITE SIGMA QUICK is a light cured, radiopaque, submicron-filled composite resin. The chemical structure of ESTELITE SIGMA QUICK is nearly identical to Tokuyama's own ESTELITE SIGMA (a modification of K#980051) and ESTELITE FLOW QUICK (K#051808). ESTELITE SIGMA QUICK is formulated to shorten the curing time of the resin material compared to ESTELITE SIGMA.
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
KO 80940
510(k) SUMMARY Tokuyama Dental Corporation ESTELITE SIGMA QUICK
JUN 19 2008
Name of Device
Trade or Proprietary Name: Common Name: Classification Name: Product Code:
ESTELITE SIGMA QUICK tooth shade resin material material, tooth shade, resin EBF
Preparation Date
March 28, 2008
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
ESTELITE SIGMA QUICK is is a light cured, radiopaque, submicron-filled composite resin for use in anterior and posterior restorations and is indicated for all carious classes.
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Technological Characteristics and Substantial Equivalence
The chemical structure of ESTELITE SIGMA QUICK is nearly identical to Tokuyama's own ESTELITE SIGMA (a modification of K#980051) and ESTELITE FLOW QUICK (K#051808). ESTELITE SIGMA QUICK is formulated to shorten the curing time of the resin material compared to ESTELITE SIGMA.
The ESTELITE SIGMA QUICK is substantially equivalent, for purposes of FDA market authorization, to Tokuyama's own ESTELITE SIGMA (K#980051 as modified) and ESTELITE FLOW QUICK (K#051808). Although the ESTELITE SIGMA QUICK has a slightly different chemical formulation than either product, these differences do not raise new questions of safety or effectiveness, as discussed below.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2008
Tokuyama Dental Corporation C/O Mr. Keith A. Barritt, Esq. Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, DC 20005
Rc: K080940
Trade/Device Name: ESTELITE SIGMA QUICK Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: April 2, 2008 Received: April 4, 2008
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.
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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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Scctions 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/industry/support/index.html.
Sincerely yours,
Sutie y. Mickeonds
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
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Indications for Use
510(k) Number (if known): K080940
Device Name: Estelite Sigma Quick
Indications for Use:
For use as a tooth shade resin in dental procedures.
Prescription Use X (21 CFR Part 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suren Russo
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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