OptiFlow II Flowable Composite, LC is a light cure resin-based flowable restorative dental composites. The restorative is packaged in capsules and syringes. The fillers are a combination of radiopaque inorganic fillers and advanced nano-silicas with an average particle size of 0.7 microns to produce a loading approximately 57% by weight (40% by volume). All shades have a radiopacity of 200%.

AI/ML Overview

The available text describes the 510(k) summary for OptiFlow II Flowable Composite, LC, a dental material. The submission focuses on demonstrating substantial equivalence to a predicate device through physical tests.

Here is the information structured according to your request, with a note where the information is not provided in the text:

1. A table of acceptance criteria and the reported device performance

The document states that the device was evaluated for Flexural Strength, Young's Modulus, Compressive Strength, Diametral Tensile Strength, and Rockwell Hardness and compared to the predicate device. However, the specific acceptance criteria (e.g., minimum values or range for each test) and the reported device performance (the actual numerical results for OptiFlow II and the predicate) are not included in this summary. It only states that the device is "substantially equivalent."

Acceptance Criteria	Reported Device Performance (OptiFlow II Flowable Composite)
Specific numerical criteria for each property (e.g., Flexural Strength > X MPa)	Not provided in the text. The document states "substantially equivalent" to predicate device.
Specific numerical criteria for each property (e.g., Young's Modulus > Y GPa)	Not provided in the text. The document states "substantially equivalent" to predicate device.
Specific numerical criteria for each property (e.g., Compressive Strength > Z MPa)	Not provided in the text. The document states "substantially equivalent" to predicate device.
Specific numerical criteria for each property (e.g., Diametral Tensile Strength > A MPa)	Not provided in the text. The document states "substantially equivalent" to predicate device.
Specific numerical criteria for each property (e.g., Rockwell Hardness > B)	Not provided in the text. The document states "substantially equivalent" to predicate device.

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

The document mentions "data from bench testing" but does not specify the sample size used for these tests. It also does not indicate the provenance (e.g., country of origin, retrospective or prospective) of this test data. Bench testing is typically conducted in a laboratory setting.

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

This document describes physical, bench-top testing of a dental material. It does not involve human interpretation or subjective assessment by experts for establishing ground truth in the way an AI diagnostic device would. Therefore, this question is not applicable to the provided context.

4. Adjudication method for the test set

Since this is bench testing of physical properties and not an expert-driven assessment, no adjudication method (like 2+1 or 3+1) was used.

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

No MRMC comparative effectiveness study was done, as this submission is for a dental material and not an AI-assisted diagnostic device involving human readers.

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

This question is not applicable as the device is a dental material, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context is the measured physical properties (Flexural Strength, Young's Modulus, Compressive Strength, Diametral Tensile Strength, and Rockwell Hardness) of the materials being tested. These are quantitative measurements derived from standardized laboratory tests.

8. The sample size for the training set

This is a physical material, not an AI model, so there is no training set in the typical sense. Physical properties are inherent to the material formulation and manufacturing process, not "trained" on data.

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

As there is no training set for a physical material, this question is not applicable.

Summary

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Section IV

510(k) Summary

Submitter: Pac-Dent International, Inc. 21038 Commerce Point Dr. Walnut, CA91789

AUG 1 3 2013

Contact Person:

Wenying Zhu Materials Scientist 909-839-0888 ext. 111

Date Summary Prepared: January 2013

Device Name

Trade Name: OptiFlow II Flowable Composite, LC Common Name: Flowable light cure provisional add-on material Classification Name: Tooth shade Resin Material, per 21 CFR 872.3690

Predicate Device Filtek™ Supreme Ultra Flowable Restorative (K100235)

Description of Device

Indications for Use

Repair of minimally invasive cavity (including non-stress bearing areas) Pit and fissure sealant

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Class III-V restorations Repair of porcelain restorations Repair of ceramic/composite veneers

Summary of Biocompatibility Tests

OptiFlow II Flowable Composite, LC is substantially equivalent to the predicate device Filtek"M Supreme Ultra Flowable Restorative in terms of materials and technological properties. It is also substantially equivalent to CuRAY Match Paint-On Composite Restor (K833810) which is produced by the same manufacturer in terms of manufacturing process. No biocompatibility test is required to establish substantial equivalence for OptiFlow II Flowable Composite, LC.

Summary of Physical Tests

This 510(k) submission includes data from bench testing to evaluate the performance of OptiFlow II Flowable Composite compared to predicate device Filtek™ Supreme Ultra Flowable Restorative. Properties evaluated include Flexural Strength, Young's Modulus, Compressive Strength, Diametral Tensile Strength and Rockwell Hardness.

Substantial Equivalence

OptiFlow II Flowable Composite, LC is substantially equivalent to the predicate device Filtek™ Supreme Ultra Flowable Restorative in terms of indications for use, composition of materials and physical properties. Physical properties evaluated include Flexural Strength, Young's Modulus, Compressive Strength, Diametral Tensile Strength and Rockwell Hardness.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized graphic of a caduceus, a symbol often associated with healthcare and medicine.

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

August 13, 2013

Pac-Dent International, Incorporated C/O Dr. Wenying Zhu Materials Scientist 21038 Commerce Point Drive Walnut, CA 91789

Re: K130672

Trade/Device Name: OptiFlow II Flowable Composite, LC Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: May 29, 2013 Received: June 4, 2013

Dear Dr. Zhu:

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 - Dr. Zhu

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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,

Mary S. Runner -S

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for PacDent International, Inc. The logo features the company name in a stylized font, with the word "PacDent" in bold letters and the tagline "passion for excellence..." underneath. The logo is set against a dark background, with a white swoosh design element above the company name. The overall design is modern and professional.

Image /page/4/Picture/1 description: The image is a black and white photograph that appears to be a close-up of a textured surface. The surface has a grainy and uneven appearance, with a mix of light and dark areas. The texture is complex and irregular, with no clear pattern or structure. The image is high contrast, with sharp transitions between light and dark areas.

.- Dent International, Inc. 21038 Commerce Pointe Dr. Walnut • California • 91789

t: 909.839.0888 f: 909.839.0881 www.pac-dent.com

Section III

Indications for Use Statement

510(k) Number (if known): K130672

OptiFlow II Flowable Composite, LC Device Name: _

Indications for Use:

OptiFlow II Flowable Composite, LC is intended for use as:

Repair of minimally invasive cavity (including non-stress bearing areas) ●
OR

Pit and fissure sealant
� Class III-V restorations
t Repair of porcelain restorations
. Repair of ceramic/composite veneers

Prescription Use

Over-The-Counter Use _

Sheena A. Greens S. 2013.08.07 10:29:43=04'00"

for M. Susan Runner, DDs, MA

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

510(k) Number;_

Image /page/4/Picture/21 description: The image shows several certification logos. From left to right, there is the NQA logo with ISO 13485:2003 and ISO 9001:2008 written below it, the UKAS logo with the number 015, the TUV logo, the FDA logo, and the CE logo with the number 0197. These logos indicate that the product or organization has met certain standards and requirements.

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.