SIMPLISEAL

K093208 · Discus Dental, LLC · KIF · Feb 12, 2010 · Dental

Device Facts

• Record ID: K093208
• Device Name: SIMPLISEAL
• Applicant: Discus Dental, LLC
• Product Code: KIF · Dental
• Decision Date: Feb 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

SimpliSeal is an epoxy-based resin root canal sealer; delivered via dual-barrel syringe; used by dentists/endodontists in clinical settings. Device functions as a sealant for root canals; applied in conjunction with gutta-percha points during endodontic procedures. Provides permanent sealing of root canal space; aids in successful obturation. Benefits patient by ensuring effective root canal seal; preventing microleakage. No complex electronics or software involved.

Clinical Evidence

Bench testing only. Testing included physical property evaluation per ISO 6876 (setting time, flow, film thickness, solubility, dimensional change) and biocompatibility testing per ISO 10993 (cytotoxicity, acute systemic toxicity, irritation, sensitivity, genotoxicity). All results were within specification.

Technological Characteristics

Epoxy-based resin root canal sealer. Premixed, two-part paste in a dual-barrel plastic syringe. Physical properties comply with ISO 6876. Biocompatibility complies with ISO 10993 standards. No electronic components, software, or energy sources.

Indications for Use

Indicated for permanent sealing of root canals following established endodontic procedures in patients requiring root canal therapy; used in conjunction with auxiliary materials like gutta-percha points. Intended for use by trained healthcare personnel.

Regulatory Classification

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.

Predicate Devices

• Adseal (K042769)
• AH-Plus (K960548)

Submission Summary (Full Text)

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K 69.3208

# FEB 1 2 2010

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# 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 [phone] - fax clarkv(@discusdental.com

May 28, 2009 Date of Summary Preparation:

- 2. 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.

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.

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- 5. 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<br>--- | Meta BioMed Co.,<br>LTD<br>--- | Dentsply Intl.<br>--- |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SimpliSeal | Adseal | AH-Plus |
| Labeling | Permanent root canal<br>sealer | Permanent root<br>canal sealer | Permanent root<br>canal sealer |
| Intended Use | SimpliSeal is a root<br>canal sealer for the<br>permanent sealing of<br>root canals following<br>established<br>endodontic<br>procedures and may<br>be used in<br>conjunction with the<br>auxiliary materials in<br>the root canal (i.e.<br>gutta percha points).<br>Intended for use by<br>qualified healthcare<br>personnel trained in<br>its use. | For permanent<br>sealing of root<br>canals following<br>established<br>endodontic<br>procedures and<br>may be used in<br>conjunction with<br>the auxiliary<br>materials in the<br>root canal (i.e.<br>gutta-percha<br>points).<br>Intended for use by<br>qualified<br>healthcare<br>personnel trained<br>in its use. | AH PLUS Root<br>Canal Sealer is<br>used for permanent<br>sealing of root<br>canals following<br>established<br>endodontic<br>procedures.<br>Intended for use by<br>qualified<br>healthcare<br>personnel trained<br>in its use. |
| Similar Physical<br>Properties | ISO 6876 fluidity,<br>working time, film<br>thickness,<br>radiopacity, solubility<br>& disintegration | ISO 6876 fluidity,<br>working time, film<br>thickness,<br>radiopacity,<br>solubility &<br>disintegration | ISO 6876 fluidity,<br>working time, film<br>thickness.<br>radiopacity,<br>solubility &<br>disintegration |
| Design,<br>Construction,<br>Components | Premixed, two part<br>paste, packaged in<br>tow component<br>plastic syringe ready<br>to be dispensed and<br>mixed. | Premixed, two part<br>paste, packaged in<br>tow component<br>plastic syringe<br>ready to be<br>dispensed and<br>mixed. | Premixed, two part<br>paste, packaged in<br>tow component<br>plastic syringe<br>ready to be<br>dispensed and<br>mixed. |

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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 [phone] or [phone] 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 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.

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

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