(22 days)
EndoREZ is used for permanent obturation of root canals of teeth of the secondary dentition with or without the aid of obturation points. It is easily delivered to the canals with a small NaviTip. When mixed and delivered in a syringe, the sealer can be used for the single cone technique or for the continuous wave condensation technique.
Not Found
This is a Food and Drug Administration (FDA) 510(k) clearance letter for a dental device called EndoREZ, a root canal filling resin. The document states that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain specific acceptance criteria, a study that proves the device meets acceptance criteria, or any of the detailed study information requested in your prompt (sample sizes, ground truth establishment, expert qualifications, etc.).
Therefore, I cannot provide the requested information about acceptance criteria and study details based on the provided text. The letter is purely an administrative clearance document.
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Image /page/0/Picture/1 description: The image shows the 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" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 6 2004
Ms. Tammy Lavery Ms. Taminy Lavery
Regulatory Affairs, Quality Assurance, Quality Consultant Senior Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095
Re: K042756
Trade/Device Name: EndoREZ Regulation Number: 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: September 23, 2004 Received: October 4, 2004
Dear Ms. Lavery:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becaler been is seeice 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 mensiale comments, or to devices that have been reclassified in accordance with the provisions of Amendinents, of to devroes that hat is of the that do not require approval of a premarket the Federal Pood, Drug, und Oosments , too, market the device, subject to the general approval application (1172). The general controls provisions of the Act include controls provisions of the stration, 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 II your device is classified (ood additional controls. Existing major regulations affecting (FMA), it may of subject to basis adam and of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the be announcements concerning your device in the Federal Register.
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Page 2 -- Ms. Lavery
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s Issualice of a substant ar secondies with other requirements
mean that FDA has made a determination that your devices Foderal agencies mean that FDA nas made a decemination that Jour and Jour Federal agencies.
of the Act or any Federal statutes and regulations administered by penistration of the Act of any rederal statues and reginaments, including, but not limited to: registration
You must comply with all the Act 's requirements and manufacturing proctice You must comply with an the Act 3 requirements and 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gract 800'; and i and listing (21 CFR Fall 807), labeling (21 OFF CFR avers) //
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set forth in the quality Systems (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) This letter will anow you to begin maileding your antial equivalence of your device to a premarket notification. The PDA midme of basians of 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), If you desire specific advice for your do at (240) 276-0115. Also, please note the regulation please contact the Othec or Comphanos are (210) = 1.0 = 1.0 = 1.0 = 1.0 = 1.0 = 1.0 = 1.0 = 1.0 = 1. may obtain other general information on your responsibilities under the Act from the may obtain other general mironmation on the mational and Consumer Assistance at its toll-free Division of Binan Manata 11, 1901) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
CluL
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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INDICATIONS FOR USE
510(k) Number (if known): __ K042756
EndoREZ Device Name: __
Indications For Use:
EndoREZ is used for permanent obturation of root canals of teeth of the secondary
It the EndoREZ is used for permanent of obturation points. It is easily delivered to the dentition with or without the all of voluration polivered in a syringe, the sealer can
canals with a small NaviTip. When mixed and delivered in a syringe, the seater can canals with a small Navil ip. "When mixed und con-resument.
X Prescription Use (Per 21 801 CFR Subpart D) AND/OR
Over-The-Counter Use (Per 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)
Susan Rumsey
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K042256
(Posted November 13, 2003)
§ 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.