SimpliSeal is a root canal sealer for the permanent sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). SimpliSeal is intended for use by qualified healthcare personnel trained in its use.

Device Description

SimpliSeal is a root canal sealer delivered in a dual-barrel syringe. This epoxy based resin sealer is easy to use with gutta-percha points and can also be used with established and more recent root canal sealing techniques. SimpliSeal with colaonent obturation of root canals when combined with obturation points.

AI/ML Overview

The provided text describes the "SimpliSeal" root canal sealer and its substantial equivalence to predicate devices, focusing on physical and biocompatibility tests. However, it does not contain a study that proves the device meets specific acceptance criteria in the context of AI or machine learning performance as requested. The document is a 510(k) summary for a medical device approval by the FDA, which relies on demonstrating equivalence to existing legally marketed devices, rather than a clinical study with detailed performance metrics against specific acceptance criteria for AI.

Therefore, many of the requested fields regarding AI/ML study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not applicable to this document.

Here's a breakdown of what can be extracted and what information is missing based on the provided text:

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

The document lists various tests performed on SimpliSeal and states that "All testing is within specification and the device performs as designed." It also compares SimpliSeal's physical properties to predicate devices (Adseal and AH-Plus) implying these shared properties serve as the performance benchmarks. However, the specific quantitative acceptance criteria (e.g., "fluidity must be X-Y mm") are not explicitly stated within the text, only the type of test (e.g., "ISO 6876 fluidity"). The reported performance is a qualitative statement of meeting specifications rather than specific numerical results.

Acceptance Criteria (Test Type - per ISO 6876 unless specified)	Reported Device Performance
Setting time	Within specification
Flow	Within specification
Film thickness	Within specification
Solubility	Within specification
Dimensional change following setting	Within specification
Cytotoxicity (ISO 10993-5)	Within specification
Acute Systemic Toxicity (oral) (ISO 10993-11)	Within specification
Irritation (ISO 10993-10)	Within specification
Sensitivity (ISO 10993-10)	Within specification
Genotoxicity (ISO 10993-3)	Within specification

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes laboratory tests, not a clinical study involving a test set of data in the context of AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as the device is not an AI/ML diagnostic tool, and the "ground truth" for its performance is based on standardized laboratory testing rather than expert-labeled clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as the device is not an AI/ML diagnostic tool, and no multi-reader adjudication process is mentioned for its performance assessment.

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 information is not provided. The device is a root canal sealer, not an AI-assisted diagnostic tool, so an MRMC study is not relevant.

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

This information is not applicable. The device is a physical product (root canal sealer), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by standardized laboratory test methods (ISO 6876 and ISO 10993 series). The performance is assessed against the specifications outlined in these international standards for dental materials and biocompatibility.

8. The sample size for the training set

This information is not provided and is not applicable as the device is not an AI/ML model.

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

This information is not applicable as the device is not an AI/ML model.

Summary

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K 69.3208

FEB 1 2 2010

, 1

510(k) Summary - SimpliSeal

Contact Person: 1.
B.

Clark D. vonAhsen Associate, Regulatory Affairs Discus Dental, LLC 8550 Higuera Street Culver City, CA 90232 310.845.8216 - phone 310.845.8647 - fax clarkv(@discusdental.com

May 28, 2009 Date of Summary Preparation:

1. Name of Medical Device

Proprietary Name:	SimpliSeal
Common/Usual Name:	Root Canal Sealer
Classification Name:	Resin, Root Canal Filling (KIF)

Substantial Equivalence Determination: 3.
Discus Dental, LLC believes that SimpliSeal is substantially equivalent to the following commercially marketed products:

Predicate Device	Company	510(k) No.
Adseal	Meta BioMed Co., LTD	K042769
AH-Plus	Dentsply Intl.	K960548

Description of Medical Device: 4.

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1. Intended Use:
  SimpliSeal is a root canal sealer for the permanent sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points).

SimpliSeal is intended for use by qualified healthcare personnel trained in its use.

Discus Dental, LLC believes that SimpliSeal is substantially equivalent to the 6. following commercially marketed products:

	Discus Dental---	Meta BioMed Co.,LTD---	Dentsply Intl.---
	SimpliSeal	Adseal	AH-Plus
Labeling	Permanent root canalsealer	Permanent rootcanal sealer	Permanent rootcanal sealer
Intended Use	SimpliSeal is a rootcanal sealer for thepermanent sealing ofroot canals followingestablishedendodonticprocedures and maybe used inconjunction with theauxiliary materials inthe root canal (i.e.gutta percha points).Intended for use byqualified healthcarepersonnel trained inits use.	For permanentsealing of rootcanals followingestablishedendodonticprocedures andmay be used inconjunction withthe auxiliarymaterials in theroot canal (i.e.gutta-perchapoints).Intended for use byqualifiedhealthcarepersonnel trainedin its use.	AH PLUS RootCanal Sealer isused for permanentsealing of rootcanals followingestablishedendodonticprocedures.Intended for use byqualifiedhealthcarepersonnel trainedin its use.
Similar PhysicalProperties	ISO 6876 fluidity,working time, filmthickness,radiopacity, solubility& disintegration	ISO 6876 fluidity,working time, filmthickness,radiopacity,solubility &disintegration	ISO 6876 fluidity,working time, filmthickness.radiopacity,solubility &disintegration
Design,Construction,Components	Premixed, two partpaste, packaged intow componentplastic syringe readyto be dispensed andmixed.	Premixed, two partpaste, packaged intow componentplastic syringeready to bedispensed andmixed.	Premixed, two partpaste, packaged intow componentplastic syringeready to bedispensed andmixed.

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The following physical tests have been completed on SimpliSeal:

Setting time - per ISO 6876 Flow - per ISO 6876 Film thickness – per ISO 6876 Solubility -- per ISO 6876 Dimensional change following setting - per ISO 6876

. The following biocompatibility tests have been completed on SimpliSeal:

Cytotoxicity - ISO 10993-5 Acute Systemic Toxicity (oral) - ISO 10993-11 Irritation - ISO 10993-10 . Sensitivity - ISO 10993-10 Genotoxicity - ISO 10993-3

All testing is within specification and the device performs as designed. The results demonstrate that the device is safe, effective and performs as well as or better than products that are already legally marketed.

END OF 510(k) SUMMARY

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a 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 a stylized design featuring three abstract shapes that resemble birds in flight or flowing ribbons.

Public Health Service

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

FEB 1 2 2010

Mr. Clark D. Von Ashsen Associate, Regulatory Affairs Discus Dental, L.L.C. 8550 Higuera Street Culver City, California 90232

Re: K093208

Trade/Device Name: SimpliSeal Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: January 21, 2010 Received: January 22, 2010

Dear Mr. Von Ashen:

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. Von Ashen

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,

hm far

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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E. Indications for Use Statement

510(k) Number (if known): _K0643208

Device Name: SimpliSeal

Indications for Use:

SimpliSeal is intended for use by qualified healthcare personnel trained in its use.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR :

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

\underline{RSBetz Das for Dr. K. P. Mully}
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K093208

Page | of |

D - 1

Regulation Number and Section

§ 872.3820 Root canal filling resin.

(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.