(35 days)
EndoSeal is easily delivered to the canals with the Endo-Eze 31 gauge tip. When mixed and delivered with the SpaTwist System, the sealer can be placed directly, to the bottom of the roct and is-filled from the borcom up, eliminating air entrapment. Using Spalvist with the Endo-Ene 31 gauge tip or capillary tip eliminates the need for gutta percha points.
Not Found
This document is an FDA 510(k) clearance letter for a dental device called "Endo-Seal". It does not describe acceptance criteria for a study, nor does it present device performance data that would allow me to populate the requested table or answer the specific questions about a study's methodology.
The document states that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This is a regulatory determination based on comparison to existing devices, not typically on a new clinical study with specific acceptance criteria and performance metrics described in the way you've outlined.
Therefore, I cannot provide the requested information from this document. I would need a different type of document, such as a clinical study report or a premarket approval (PMA) application summary, to answer your questions.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chester McCoy Regulatory Affairs & Quality Assurance Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095
JUN 2 6 1997
- K971899 Re : Endo-Seal Trade Name: Regulatory Class: II Product Code: KIF Dated: May 12, 1997 Received: May 22, 1997
Dear Mr. McCoy:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. McCoy
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1971899 5 10(k) Number (if known):
EndoSea1 Device Namc:
Indications For Usc:
EndoSeal is easily delivered to the canals with the Endo-Eze 31 gauge tip. When mixed and delivered with the SpaTwist System, the sealer can be placed directly, to the bottom of the roct and is-filled from the borcom up, eliminating air entrapment. Using Spalvist with the Endo-Ene 31 gauge tip or capillary tip eliminates the need for gutta percha points.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODB)
Susan Lunorr
(Division Sign-Off) (Division of Dental, Infectio and General Hospita 510(k) Number
Prescription Use (Por 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
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§ 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.