Build-It Total Core is a dual-cure, self-adhesive composite with a continuous fluoride release. Build-It Total Core utilizes 4-MET technology to adhere to dentin and cut enamel without a separate bonding agent. Ideal flow characteristics, esthetic and contrast shades, and outstanding physical properties make Build-It Total Core an indispensable tool in every clinician's armamentarium.

AI/ML Overview

The provided document describes a 510(k) submission for a dental composite material called "Build-It Total Core." It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Here's an analysis based on the information provided, addressing your specific points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria with corresponding device performance values against those criteria. Instead, it lists characteristics evaluated and states that the performance characteristics were compared to predicate devices (Build-It F.R. and Cement-It All Purpose).

Characteristic Evaluated	Reported Device Performance	Acceptance Criteria (Implicit)
Water absorption	Compared to predicate devices	Performance similar to predicate devices
Solubility	Compared to predicate devices	Performance similar to predicate devices
Flexural strength	Compared to predicate devices	Performance similar to predicate devices
Compression strength	Compared to predicate devices	Performance similar to predicate devices
Linear expansion in water	Compared to predicate devices	Performance similar to predicate devices
Fluoride release	Compared to predicate devices	Performance similar to predicate devices
Bond strength	Compared to predicate devices	Performance similar to predicate devices
Biocompatibility	Demonstrated material is safe	Material is safe for its intended use

Explanation of "Acceptance Criteria (Implicit)": Since this is a 510(k) submission demonstrating substantial equivalence, the "acceptance criteria" for these performance characteristics are implicitly met if the test results for Build-It Total Core are similar to or equivalent to the legally marketed predicate devices. The document does not provide the specific numerical values for these characteristics for either the new device or the predicates.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document mentions "bench testing used to evaluate performance characteristics" but does not specify the sample sizes used for any of the tests (water absorption, solubility, flexural strength, etc.).
Data Provenance: The data is from "bench testing," implying in-vitro testing conducted by the manufacturer, Sybron Dental Specialties, Inc. The country of origin of the data is not explicitly stated, but given the submitter's address in California, USA, it's likely U.S.-based. This is retrospective in the sense that the testing was performed to support the 510(k) submission for a finished device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable to this type of submission. The "ground truth" for the performance characteristics measured (e.g., flexural strength) is established by standardized test methods and calibrated equipment, not by expert consensus on, for example, diagnostic images.

4. Adjudication Method for the Test Set

This question is not applicable as there's no diagnostic or interpretive element requiring expert adjudication.

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 question is not applicable. This submission is for a dental material, not an AI-powered diagnostic device, and therefore no MRMC study was performed.

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

This question is not applicable. This submission is for a dental material, not an algorithm, so no standalone algorithm performance study was done.

7. The Type of Ground Truth Used

For the biocompatibility study, the ground truth is established through standardized biological evaluations as outlined in relevant standards (e.g., ISO 10993 series), leading to a conclusion of safety for intended use.

For the bench testing performance characteristics (flexural strength, bond strength, etc.), the "ground truth" is the measured physical properties of the material under controlled laboratory conditions, obtained through validated test methods.

8. The Sample Size for the Training Set

This question is not applicable. This is not an AI/machine learning device, so there is no "training set." The product is a physical dental material.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set for this device.

Summary

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Kl02703.

Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a smaller, sans-serif font. The logo is in black and white.

JAN - 5 2011

Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue ! Orange, California 92867 (714) 516-7602 - Phone (714) 516-7472 - Facsimile Wendy Garman - Contact Person

Date Summary Prepared:

December 2010

Device Name:

· Trade Name Build-It Total Core
Common Name Dental Composite Restorative Material
· Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690

Devices for Which Substantial Equivalence is Claimed:

Build-It F.R., K000211, Pentron Clinical
· Cement-It All Purpose, K060698, Pentron Clinical

Device Description:

Intended Use of the Device: (

Build-It Total Core is indicated for use as a core build up material on vital and non-vital teeth, sealing root canal openings, cavity floor liner, post cementation, restorative material and dentin replacement material. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Substantial Equivalence:

Build-It Total Core is substantially equivalent to two other legally marketed devices in the United States. Build-It Totol Core functions in a manner similar to and is intended for the same use as Build-It F.R, manufactured by Pentron Clinical. Its self-adhering properties are equivalent to Cement-It All Purpose, currently marketed by Pentron Clinical as Breeze. Build-It Total Core is similar to Build-It F.R in that it is a fiber reinforced, dual cure post and core build-up resin composite material which is used for tooth restorations. Build-It Total Core differs from Build-It F.R in that it utilizes 4-MET technology to adhere to dentin and cut enamel without a separate bonding agent. Build-it Total Core is similar to Cement-It All Purpose, a self-adhering dental cement currently marketed by Pentron Clinical as Breeze, in that it has a similar formulation and it has self-adhering properties.

Non-Clinical Test Data

A biocompatibility study was completed, which demonstrates that the material is safe for its intended use. This 510(k) submission also includes data from bench testing used to ēvaluate performance characteristics of Build-It Total Core compared to the predicate devices, Build-It F.R. and Cement-It All Purpose currently marketed by Pentron Clinical as Breeze. The characteristics evaluated include water absorption and solubility, flexural and compression strength, linear expansion in water, fluoride release, and bond strength.

Clinical Testing

Clinical testing has not been conducted on this product.

Conclusion:

Based upon the biocompatibility studies and similar technological/performance characteristics as compared to the predicate devices, the clinical performance of Build-It Total Core is deemed to be substantially equivalent to the predicate devices, Build-It F.R. and Cement-It All Purpose currently marketed by Pentron Clinical as Breeze.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

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

Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92867

Re: K102703

Trade/Device Name: Build-It Total Core Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: December 6, 2010 Received: December 7, 2010

JAN - 5 2011

Dear Ms. Garman:

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- Ms. Garman

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,

Nh for

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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Indications for Use

510(k) Number (if known): K102703

JAN - 5 2011

Device Name: Build-It Total Core

Indications For Use:

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use ___________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices Page 1 of 1
1 510(k) Number:	K182703

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.