(50 days)
Not Found
No
The 510(k) summary describes a dental composite resin material and its physical properties, with no mention of AI or ML technology.
No
The device is a dental restorative material used for filling cavities and repairing teeth, not for treating diseases or improving health through therapy.
No
EsFlow is a composite resin material used for dental restorations, not for diagnosing medical conditions. It is a material for treatment and repair, with described mechanical properties, not diagnostic capabilities.
No
The device is a physical material (composite resin) used in dental procedures, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a material used directly on the patient's teeth for restorative purposes. IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description details a dental composite resin with physical properties and shades, not a test or assay for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
This device falls under the category of a dental restorative material, which is a medical device but not an IVD.
N/A
Intended Use / Indications for Use
EsFlow is a low viscous, light cured hybrid composite dental tooth shade resin material. It is intended for use in various dental procedures, including direct anterior and posterior restorations (particularly for small/shallow/tunnel shaped cavities), as the first layer of direct restorations, blocking out cavity undercuts before fabricating indirect restorations, and repair of porcelain/composite materials.
Product codes
EBF
Device Description
EsFlow is light-cured flowable composite resin which makes it ideal for small cavities in anterior and posterior teeth. It has the characteristics of good flowability, high compressive strength, and radiopaque. It has 17 shades: A1, A2, A3, A3.5, B2, B3, I, UO, LA1,LA2,LA3, LA3.5, LB2, LB3,LUO, White, Yellow.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior teeth
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
The EsFlow has been subjected to extensive safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the US regulations and ISO 4049.
Key Metrics
Not Found
Predicate Device(s)
ESTELITE FLOW QUICK, K051808
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
MAY - 3 2012
SPIDENT Co., Ltd.
203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, Incheon, Korea 405-821 Tel: +82(32)819-4570 Fax : +82(32)819-4572
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).
Date: December. 22, 2011
- Company and Correspondent making the submission:
| Company | |
|---|---|
| Name | SPIDENT Co., Ltd. |
| Address | 203 & 312, Korea Industrial Complex, 722, |
| Gojan-Dong, Namdong-Gu, Incheon, Korea | |
| 405-821 | |
| Phone | +82(32)819-4570 |
| Fax | +82(32)819-4572 |
| Contact | J. M. Ahn/President |
2. Device:
Proprietary Name - EsFlow Common Name - Tooth shade resin material Classification Name - material, tooth shade, resin.
-
- Predicate Device:
ESTELITE FLOW QUICK, K051808
- Predicate Device:
-
- Classifications Names & Citations: EBF, 872.3690
-
- Description:
EsFlow is light-cured flowable composite resin which makes it ideal for small cavities in anterior and posterior teeth. It has the characteristics of good flowability, high compressive strength, and radiopaque. It has 17 shades: A1, A2, A3, A3.5, B2, B3, I, UO, LA1,LA2,LA3, LA3.5, LB2, LB3,LUO, White, Yellow.
EsFlow is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. It is substantially equivalent in design, function and intended use to the predicate devices.
000021
1
Image /page/1/Picture/0 description: The image shows the word "SPIDENT" in a bold, sans-serif font. The word is enclosed in a rectangular box with rounded corners. The top of the box is open above the letters "PI".
SPIDENT Co., Ltd.
203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, Incheon, Korea 405-821 Tel: +82(32)819-4570 Fax : +82(32)819-4572
- Indication for use:
EsFlow is a low viscous, light cured hybrid composite dental tooth shade resin material. It is intended for use in various dental procedures, including direct anterior and posterior restorations (particularly for small/shallow/tunnel shaped cavities), as the first layer of direct restorations, blocking out cavity undercuts before fabricating indirect restorations, and repair of porcelain/composite materials.
-
- Review:
The EsFlow has the similar device characteristics as the predicate device, the ESTELITE FLOW QUICK; intended use, material, chemical composition, design and use concept are similar.
- Review:
The EsFlow has the similar mechanical properties as the predicate device; compressive strength, flexural strength, flow thickness, wear, polymerization shrinkage and thermal expansion coefficience.
The EsFlow has been subjected to extensive safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the US regulations and ISO 4049.
Based on the comparison of intended use and technical features, the EsFlow is substantially equivalent to the predicate devices. ·
- Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807. FDA's "Guidance for the Preparation of Premarket notifications for Dental Composite" and based on the information provided in this premarket notification SPIDENT Co., Ltd. concludes that the EsFlow is safe and effective and substantially equivalent to predicate devices as described herein.
000022
-
- SPIDENT Co., Ltd. will update and include in this summary any other information decmed reasonably necessary by the FDA.
END
- SPIDENT Co., Ltd. will update and include in this summary any other information decmed reasonably necessary by the FDA.
2
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 eagle or bird-like figure with three distinct strokes forming its body and wings. The bird is oriented diagonally from the upper right to the lower left. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spident Company, Ltd C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Inc. 2600 NW Lake Road Camas, Washington 98607
MAY - 3 2012
K120768 Re:
Trade/Device Name: EsFlow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: April 18, 2012 Received: April 26, 2012
Dear Mr. Mouser:
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.
3
Page 2 - Mr. Mouser
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 device-related adverse events) (21 CFR 803); 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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony V. Ware
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Submission - EsFlow
510(k) Number K k1200765
Device Name: EsFlow
Indication for use:
EsFlow is a low viscous, light cured hybrid composite dental tooth shade resin material. It is intended for use in various dental procedures, including direct anterior and posterior restorations (particularly for small/shallow/tunnel shaped cavities), as the first layer of direct restorations, blocking out cavity undercuts before fabricating indirect restorations, and repair of porcelain/composite materials.
| Prescription Use | |
|---|---|
| (Per 21CFR801 Subpart D) |
Over-The-Counter Use AND/OR (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) NO (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 000020 510(k) Number:
SPIDENT CO., LTD.