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K Number
K120767
Device Name
ES BOND
Manufacturer
SPIDENT CO., LTD.
Date Cleared
2012-05-24

(71 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
Dental
Reference & Predicate Devices
K945604
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. All Direct Composite Restorations
  2. Directed Shrinkage Composite Restorations
  3. Desensitization of Crown Preparations Prior to Impression Making/Provisionalization
  4. Composite Core Build-Ups
  5. Composite to Composite (Repair)
  6. Composite to Metal/Set Amalgam (Direct Veneering)
  7. Root Desensitization
Device Description

EsBond is 5th generation that provides high bonding strengths in a convenient single bottle application. That single component bonding agent designed to bond all classes of direct composite restorations to dentin, enamel, as well as composite, treated porcelain and set amalgam.

AI/ML Overview

The provided text is a 510(k) summary for a dental bonding adhesive (EsBond) and its FDA clearance letter. It does not contain information about acceptance criteria, a specific study proving it meets these criteria, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document states that EsBond has "similar mechanical properties as the predicate device; compressive strength, flexural strength, flow thickness, wear, polymerization shrinkage and thermal expansion coefficience" and that "Safety tests including biocompatibility have been performed to ensure the devices comply with the US regulations and ISO 4049." However, it does not provide the specific acceptance criteria for these properties or the results of the tests against these criteria.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and the reported device performance.
  2. Sample sizes used for the test set and the data provenance.
  3. Number of experts used to establish the ground truth for the test set and their qualifications.
  4. Adjudication method for the test set.
  5. MRMC comparative effectiveness study details.
  6. Standalone performance details.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How the ground truth for the training set was established.

This document focuses on establishing substantial equivalence to a predicate device (ECLIPTOMER, BISCO, INC., K945604) based on intended use, materials, chemical composition, design, use concept, and general mechanical properties, rather than providing a detailed study report with specific acceptance criteria and performance data as you've requested for an AI/device study.

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K120767..

Image /page/0/Picture/1 description: The image shows the date May 24, 2012. The text is in all caps and is left-aligned. The font is a simple sans-serif font and the text is black against a white background.

000021

SPIDENT Co., Ltd.

SPIDENT

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: January 10, 2012

  1. Company and Correspondent making the submission:
Company
NameSPIDENT Co., Ltd.
Address203 & 312, Korea Industrial Complex, 722,Gojan-Dong, Namdong-Gu, Incheon, Korea405-821
Phone+82(32)819-4570
Fax+82(32)819-4572
ContactJ. M. Ahn/President
    1. Device:
      Proprietary Name - EsBond Common Name - Dental bonding adhesive Classification Name - Resin tooth bonding Agent
    1. Predicate Device:
      ECLIPTOMER, BISCO, INC., K945604
    1. Classifications Names & Citations: KLE, 872.3200
    1. Description:

EsBond is 5th generation that provides high bonding strengths in a convenient single bottle application. That single component bonding agent designed to bond all classes of direct composite restorations to dentin, enamel, as well as composite, treated porcelain and set amalgam.

EsBond 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.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a logo with the word "SPIDENT" in bold, black letters. The letters are enclosed in a square border, with the top of the square having a small gap in the middle. The logo has a simple, clean design and appears to be for a company or product named "SPIDENT".

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

  1. Indication for use:
  1. All Direct Composite Restorations
    1. Directed Shrinkage Composite Restorations
    1. Desensitization of Crown Preparations Prior to Impression Making/Provisionalization

  1. Composite Core Build-Ups

  2. Composite to Composite (Repair)

  3. Composite to Metal/Set Amalgam (Direct Veneering)

  4. Root Desensitization

  1. Review:

The EsBond has the similar device characteristics as the predicate device, the ECLIPTOMER; intended use, material, chemical composition, design and use concept are similar.

The EsBond has the similar mechanical properties as the predicate device; compressive strength, flexural strength, flow thickness, wear, polymerization shrinkage and thermal expansion coefficience.

The EsBond 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 EsBond is substantially equivalent to the predicate devices.

  1. 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 EsBond is safe and effective and substantially equivalent to predicate devices as described herein.

000022 .

    1. SPIDENT Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
      END

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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 and Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Spident Company, Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Inc. 2600 NW Lake Road Camas. Washington 98607

MAY 24 20

Re: K120767

Trade/Device Name: EsBond Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE 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.

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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,

hh fo.

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

Enclosure

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510(k) Submission - EsBond
--------------------------------

510(k) Number K K120767

Device Name: EsBond

Indication for use:

    1. All Direct Composite Restorations
    1. Directed Shrinkage Composite Restorations
    1. Desensitization of Crown Preparations Prior to Impression Making/Provisionalization
    1. Composite Core Build-Ups
    1. Composite to Composite (Repair)
    1. Composite to Metal/Set Amalgam (Direct Veneering)
    1. Root Desensitization

Over-The-Counter Use Prescription Use______________________________________________________________________________________________________________________________________________________________ AND/OR (Per 21CFR807 Subpart C) (Per 21CFR801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number:K120767

SPIDENT CO., LTD. 000020

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.