(210 days)
SE Epiphany Root Canal Sealant is intended for 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.
The provided document is a 510(k) summary for a medical device (SE Epiphany Root Canal Sealant) and its FDA clearance letter. It does not describe an AI medical device or a study involving an AI algorithm. Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI device meets those criteria.
The document pertains to a dental root canal sealant and its substantial equivalence to a predicate device based on its intended function, composition, and manufacturing process. It's a traditional medical device submission, not one related to AI or algorithmic performance evaluation.
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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: 203-265-3074 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use(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
§ 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.