SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE

K060889 · Pentron Clinical Technologies · KIF · Oct 27, 2006 · Dental

Device Facts

• Record ID: K060889
• Device Name: SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE
• Applicant: Pentron Clinical Technologies
• Product Code: KIF · Dental
• Decision Date: Oct 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SE Epiphany Root Canal Sealant is intended for permanent obturation of root canals of teeth in combination with root canal points.

Device Story

SE Epiphany Root Canal Sealant is a self-etch methacrylate resin-based root canal sealant; supplied as a catalyst/base paste in an automix dual-barrel syringe. Designed for permanent obturation of root canals in combination with root canal points. Self-etching and adhering properties eliminate need for separate etchant, primer, or adhesive. Dual-cure capability allows for polymerization. Used by dentists in clinical settings to seal root canals; provides strength and radiopacity via barium boro-silicate glass filler. Benefits include simplified application and effective canal obturation.

Clinical Evidence

No clinical data provided; safety and effectiveness review performed.

Technological Characteristics

Self-etch methacrylate resin; catalyst/base paste formulation. Filler: 60-70% by weight barium boro-silicate glass (particle size < 2 microns). Dual-cure capability. Supplied in automix dual-barrel syringes. Radiopaque.

Indications for Use

Indicated for permanent obturation of root canals of teeth in combination with root canal points. Prescription use only.

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

• First Fill (K011748)

Submission Summary (Full Text)

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Ko 60889

Image /page/0/Picture/1 description: The image shows the logo for Pentron Clinical Technologies, LLC. The logo consists of a stylized image to the left of the company name. The stylized image is a series of horizontal lines that are stacked on top of each other, with the lines getting shorter as they go up. The company name is written in a simple, sans-serif font.

OCT 2 7 2006

Advancing dentistry one innovation at a time."

#### 6.0 510(K) SUMMARY

Pentron Clinical Technologies, LLC. 68 North Plains Industrial Road Wallingford, CT 06492 203-265-7397 Tel: Fax: [phone] Contact: Greg Moreau

| Trade Name: | SE Epiphany Root Canal Sealant |
|----------------------|------------------------------------------------|
| Common Name: | Dental root canal sealant |
| Classification Name: | Dental Root Canal Sealant, 21CFR 872.3820, KIF |

SE Epiphany Root Canal Sealant product performs the same intended function as its predicate device, First Fill (reference K011748). Both devices are intended for the permanent obturation of root canals of teeth in combination with root canal points.

The subject device is a self-etch methacrylate resin root canal sealant in a catalyst/base paste formulation. Due to its self-etching and adhering properties, SE Epiphany Root Canal Sealant does not require the use of an etchant, primer or adhesive to achieve its intended function. SE Epiphany Root Canal Sealant has been designed for dual cure capabilities.

Device composition is approximately 60-70% filler by weight with filler particle size values less than 2 microns. As with other resin products manufactured by Pentron Clinical Technologies, LLC., the predominant filler for SE Epiphany Root Canal Sealant is a barium boro-silicate glass. This filler type provides the subject device with the required strength and radiopacity features.

Product is supplied within automix dual barrel syringes for ease of dispensing directly into the restorative site.

A review for safety and effectiveness was performed and found not to have been affected.

510(k) Submission for SE Epiphany Root Canal Sealant

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Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### OCT 2 7 2006

Mr. Greg Moreau Pentron Clinical Technologies 68-70 North Plains Industrial Road Wallingford, Connecticut 06492

Re: K060889

Trade/Device Name: SE Epiphany Root Canal Sealant Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Post Regulatory Class: II Product Code: KIF Dated: October 6, 2006 Received: October 10, 2006

Dear Mr. Moreau:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Moreau

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 on works not of the Act or any Federal statutes and regulations administered by other Federal ogencies. 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Shule A Murphy, MD for Chu Lin, Ph D

Chiu Lin, Ph.D. 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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# 5.0 INDICATION FOR USE STATEMENT

# 510(k) NUMBER (IF KNOWN): Ko b 0 8 8 9

## DEVICE NAME: SE Epiphany Root Canal Sealant

#### INDICATION FOR USE:

SE Epiphany Root Canal Sealant is intended for permanent obturation of root canals of teeth in combination with root canal points.

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

14. 11. 11. 1

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|----------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | X |
| OR | Over-The-Counter-Use |
| (Optional Format 1-2-96) | |

*Kei Haley for HSR*

510(k) Submission for SE Epiphany Root Canal Sealant

of Anesthesiology, General Hospital,
con Consol, Dental Devices

*K060889*