Ti-Core® Flow+ is indicated for vital or non-vital tooth core build-up (replacement of existing restorations and/or lost tooth structure), as a base prior to fabricating an indirect restoration, and as a post cement. Ti-Core® Flow+ is also indicated for cementing of endodontic posts, crowns, bridges, inlays, onlays, and for core build-ups.

Device Description

Ti-Core® Flow+ is a dual-cure resin cement that can be used as a luting agent and core material. It is packaged in the familiar double-barrel syringe and our materials with the puttless other dental materials. The steps required to oroperly express the cement are: remove cap, attach mixer, attach dispensing tip, press plunger. After use, the mixer/dispensing tip should be discarded and the cap replaced.

The contents of the kit are
2 - Dual chambered syringes each containing 9 am resin cement

20 Mixers
10 - Thin dispensing tips
10 - Thick dispensing tips

AI/ML Overview

The provided document describes the acceptance criteria and the study conducted for the Ti-Core® Flow+ dental resin cement.

Acceptance Criteria and Device Performance

Acceptance Criteria (ISO Standard 4049)	Reported Device Performance (Ti-Core® Flow+)	Details
Film thickness	Meets or exceeds ISO specification	Non-clinical performance testing conducted.
Working and setting time	Meets or exceeds ISO specification	Non-clinical performance testing conducted.
Sensitivity to ambient light	Meets or exceeds ISO specification	Non-clinical performance testing conducted.
Depth of cure	Meets or exceeds ISO specification	Non-clinical performance testing conducted.
Flexural strength	Meets or exceeds ISO specification	Non-clinical performance testing conducted.
Water solubility and sorption	Meets or exceeds ISO specification	Non-clinical performance testing conducted.
Radiopacity	Does not meet due to "not claimed"	The device's radiopacity is not claimed and thus does not meet the specification, but this is presented as acceptable.

Study Information

Sample size used for the test set and the data provenance:
The document does not specify a distinct "test set" in the traditional sense for a clinical study. The performance evaluation was based on non-clinical tests conducted according to ISO standard 4049. The sample size for these non-clinical tests (e.g., number of specimens for film thickness, flexural strength) is not provided. The provenance of these non-clinical test materials (e.g., origin of the raw materials, specific lab where tests were conducted) is also not explicitly stated, though it's implied the testing was done by Essential Dental Systems or a contracted lab.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This was a non-clinical, in-vitro study based on ISO standard specifications, not a study requiring expert clinical ground truth assessment on human data.
Adjudication method for the test set:
Not applicable. This was a non-clinical, in-vitro study.
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:
Not applicable. This document pertains to a dental resin cement, not an AI-powered diagnostic device, and no human reader studies are described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device.
The type of ground truth used:
The "ground truth" for evaluating the device's performance against its acceptance criteria was the ISO standard 4049 specification limits for various physical and chemical properties of dental resin cements.
The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
Not applicable. There is no training set for this device.

Summary

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Exhibit #1

OCT 2 9 2010

510(k) SUMMARY

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K101504.

1. Submitter's Identification: Essential Dental Systems 89 Leuning Street South Hackensack, NJ 07606
  Date Summary Prepared: May 28, 2010 Date Summary Revised: October 15, 2010

Contact: Mr. Jeffrey Wan Contact Phone #: 201-487-9090 ext. 118 Contact Fax #: 201-487-5120

2. Name of the Device:

Trade name: Ti-Core® Flow+ Common name: dental resin cement Classification name: dental cement (21 CFR 872.3275, Product Code EMA)

Predicate Device Information: 3.

Fluorocore 2+, K#083326, Dentsply International, York, PA
ParaCem Universal DC, K#053040, Coltene/Whaledent AG, New York, NY
Ti-Core Natural, K#922251, Essential Dental Systems, South Hackensack, NJ

Device Description: 4.

The contents of the kit are

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2 - Dual chambered syringes each containing 9 am resin cement

20 Mixers
10 - Thin dispensing tips

10 - Thick dispensing tips

5. Intended Use:

6. Comparison to Predicate Devices:

The subject device is similar to Fluorocore 2+ and ParaCem Universal in that they are dual-cure resin cement that can be used as a luting agent and core material. These materials are packaged in the familiar double-barrel syringe configuration used by countless other dental materials. The directions for use for these materials are nearly identical. On a high level, the formulation of these products are the same. They are comprised of two pastes each containing methacrylate monomers with glass and/or quartz fillers. One paste contains photoinitiators and cure accelerators while the other contains self-cure initiators.

Because detailed formulations for these two predicate devices do not appear in the public domain, we have cited an additional predicate device for which we do have complete formulation data for: Ti-Core Natural. The subject device contains the same components of Ti-Core Natural with the addition of the popular photoinitiators camphorquinone and ethyl 4 dimethylamino benzoate and the methacrylate resin dimethylaminoethyl methacrylate.

Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as Follows:

Biocompatibility literature supplied with this 510(k) submission along with Material Safety Data Sheets, has shown that the materials in Ti-Core® Flow+ do not raise any new safety/biocompatibility concerns.

Non-clinical performance testing for Ti-Core® Flow+ and Fluorocore 2+ was conducted according to ISO standard 4049. This includes evaluation of film thickness, working and setting time, sensitivity to ambient light, depth of cure, flexural strength, water solubility and sorption, and radiopacity. Results of the testing conclude that Ti-Core® Flow+ meets or exceeds the ISO specification except for radiopacity, which is not claimed by the proposed device.

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Discussion of Clinical Tests Performed: 8.

Not Applicable

9. Conclusions:

Ti-Core® Flow+ has the same intended use and similar technological characteristics as the predicate devices. Moreover, the literature supplied in this submission demonstrates that any differences in their material formulations do not raise any new questions as to safety or effectiveness. Thus, Ti-Core® Flow+ is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines forming its body and wings. The eagle is oriented diagonally in the center of the seal. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

Mr. Jeffery Wan Research & Development Manager Essential Dental Systems, Incorporated 89 Leuning Street, Suite 8 South Hackenack, New Jersey 07606

Re: K101504 Trade/Device Name: Ti-Core® Flow Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: October 15, 2010 Received: October 19, 2010

OCT 2 9 2010

Dear Mr. Wan:

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. Wan

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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Exhibit B

Indications for Use

Page 1_of 1

510(k) Number (if known): K101504

OCT 2 9 2010

Device Name: Ti-Core® Flow+

Indications for Use:

Prescription Use × (Per 21 CFR 801 Subpart D)

Over the Counter Use (Per 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 (ODE)

Susan Ruaser

Division Sign-Off) Division of Anesthesiology, General Hospital ' - fection Control, Dental Devices

:10(k) Number: k1) k504

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.