The principal use for Core it Dual is as a core material either with adhesives or with pins or posts. Core it Dual can also be used for: Luting of abutments to dentures; Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials; Repair material for provisionals; Bite registration material; Build up material for plastic bite rails (occlusal individualisation); Cement for pins and posts; Semipermanent restorative material (e.g., in childrens' teeth)

Device Description

The Core it Dual is a dual-cured composite resin designed for the fabrication of core build-ups & build-up fillings. It has the characteristics of good depth of polymerization, high compressive strength, and radiopaque. It has two shades (Blue, yellow).

AI/ML Overview

This looks like a 510(k) summary for a dental product, specifically a core build-up resin. These types of summaries rarely contain detailed clinical study information in the way you've outlined. They primarily focus on demonstrating substantial equivalence to a predicate device through material properties and intended use.

Based on the provided text, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a numerical or statistical format often seen for performance outcomes in clinical studies for AI/software devices. Instead, it discusses the similarity of mechanical properties to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Similar mechanical properties to the predicate device (LuxaCore Dual)	The Core it Dual has similar mechanical properties as the predicate device: compressive strength, flexural strength, flow thickness, wear, polymerization shrinkage, and thermal expansion coefficient.
Compliance with US regulations and ISO 4049 (biocompatibility)	Safety tests including biocompatibility have been performed to ensure the devices comply with the US regulations and ISO 4049.

2. Sample size used for the test set and the data provenance:

Sample Size: Not mentioned. The document primarily focuses on material properties testing, not a clinical test set in the traditional sense.
Data Provenance: Not mentioned. The testing was likely conducted in a lab setting, possibly by the manufacturer or a contracted lab. The country of origin for the company is Korea.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable to this type of device and study. Ground truth established by experts is typically relevant for diagnostic or image analysis software. For a dental material, the "ground truth" is typically established by standardized material testing methods.

4. Adjudication method for the test set:

This is not applicable as there is no mention of a test set requiring adjudication in the context of human expert review.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. This device is a dental material, not an AI or software device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This is not applicable. This is a dental material, not an algorithm.

7. The type of ground truth used:

For dental materials, "ground truth" is typically established by:

Standardized material testing: Using recognized international (e.g., ISO) or national (e.g., ADA) standards for mechanical properties like compressive strength, flexural strength, wear, etc.
Biocompatibility testing: According to standards like ISO 10993.

The document implicitly refers to this through statements like: "The Core it Dual has the similar mechanical properties as the predicate device; compressive strength, flexural strength, flow thickness, wear, polymerization shrinkage and thermal expansion coefficience" and "Safety tests including biocompatibility have been performed to ensure the devices comply with the US regulations and ISO 4049."

8. The sample size for the training set:

This is not applicable. There is no training set in the context of an AI/software device. This refers to the development and testing of a physical material.

9. How the ground truth for the training set was established:

This is not applicable.

Summary of the Study/Testing:

The "study" described in the 510(k) summary is primarily focused on demonstrating substantial equivalence of the Core it Dual dental composite resin to a legally marketed predicate device (LuxaCore Dual). This demonstration relies on comparing:

Intended Use: "The Core it Dual is similar to other commercially available products based on the intended use..."
Technology/Material Composition: "The Core it Dual is similar to other commercially available products based on the ...material composition employed..." and "...material, chemical composition, design and use concept are similar [to the predicate device]."
Performance Characteristics/Mechanical Properties: "The Core it Dual has the similar mechanical properties as the predicate device; compressive strength, flexural strength, flow thickness, wear, polymerization shrinkage and thermal expansion coefficience." These properties were likely assessed through in-vitro laboratory testing according to relevant dental material standards.
Safety/Biocompatibility: "Safety tests including biocompatibility have been performed to ensure the devices comply with the US regulations and ISO 4049."

The document states, "The Core it Dual has been subjected to extensive safety, performance, and product validations prior to release." This indicates that laboratory testing was performed to establish its properties and confirm its similarity to the predicate device, rather than a clinical study with human subjects, expert readers, or AI algorithms.

Summary

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ag 2572

SPIDENT Co., Ltd. 4312, 151B-6L, NamdosgKongDan, Inchesn, Korea 405-821 Tel: +82(32)8 19-4570 Fax : +82(32)3 19-4572

510(k) Summary

This summary of 5 00(k) salety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(ci.

Date: July 22, 2009

Company and Correspondent making the submission

AUG 2 6 2009

	Company
Name	SPIDENT Co., Ltd.
Address	#312, 151B-6L, NamdongKongDan,Incheon, Korea 405-821
Phone	+82(32)819-4570
Fax	+82(32)819-4572
Contact	I. S. Whang

Device:

Proprietary Name - Core · it Dual Common Name - Core Build ep Resin Classification Name - Tooth shade resin material

1. Predicate Device:
  LuxaCore/ LuxaCore Dual, KD12307
1. Classifications Names & Citations: EBF, 872.3690
1. Description:

The Core it Dual is a dual-cered composite resin designed for the fabrication of core build-ups & build-up fillings. It has the characteristics of good depth of polymerization, high compressive strength, and radiopaque. It has two shades (Blue, yellow).

The Core it Dual 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 cquivalent in design, function and intended use to the predicate devices.

021

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Image /page/1/Picture/0 description: The image shows a logo with the word "SPIDENT" inside a square. The letters are in a bold, sans-serif font and appear to be slightly distressed or textured. The square border around the word is also thick and has a similar distressed appearance, giving the logo a somewhat vintage or worn look.

SPIDENT Co., Ltd.

#312, 151B-6L, NamstongRongDun, Incheon, Korea 405-821 Tel: +82(32)819-4570 Fax : +82(32)819-4572

Indication for use:

The principal use for Core it Dual is as a core material cither with adhesives or with pins or posts. R

Core it Dual can also be used for:

· Luting of abutments to dentures

· Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials
· Repair material for provisionals
· Bite registration material.
· Build up matcrial for plastic bite rails (occlusal individualisation).
· Cement for pins and posts
· Semipermanent restorative material (e.g., in childrens' tecth)

7. Review:

The Core it Dual has the similar device characteristics as the predicate device, the Luxa Core Dual; intentied use, material, chemical composition, design and use concept are similar.

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

The Core it Dual 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 Core it Dual 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 Core it Dual is safe and effective and substantially equivalent to predicate devices as described herein.

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

END

022

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or birds in flight, stacked on top of each other.

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

Spident Company, Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated Laboratory and Testing 2600 NW Lake Road Camas, Washington 98607-9526

Re: K092572

Trade/Device Name: Core it Dual Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: July 29, 2009 Received: August 21, 2009

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.

AUG 2 6 2009

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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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/Reporta Problem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runner, D.D.S., M.A. Acting 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) Number K 092572

Device Name: Core it Dual

Indication for use:

The principal use for Core it Dual is as a core material either with adhesives or with pins or posts.

Corc+it Dual can also be used for:

Luting of abutments to dentures i

Splinting of teeth in combination with wires, Kevlar or Ribbond-type materials 높
Repair material for provisionals
Bite registration material.
Build up material for plastic bite rails (occlusal individualisation).
Cement for pins and posts
Semipennanent restorative material (e.g., in childrens teeth)

Prescription Use AND/OR Over-The-Counter Use (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)

SPIDENT CO., LTD.

Ren Mely for MSR

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number: K092572

020

Regulation Number and Section

§ 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.