ENDOREZ

K042756 · Ultradent Products, Inc. · KIF · Oct 26, 2004 · Dental

Device Facts

• Record ID: K042756
• Device Name: ENDOREZ
• Applicant: Ultradent Products, Inc.
• Product Code: KIF · Dental
• Decision Date: Oct 26, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 root canal treatment.

Device Story

EndoREZ is a root canal filling resin used by dentists for permanent obturation of root canals. The device is supplied in a syringe and delivered into the root canal using a small NaviTip. It functions as a sealer to fill the canal space, either alone or in conjunction with obturation points. The procedure is performed in a clinical dental setting. By providing a permanent seal, the device aids in the successful completion of root canal therapy, preventing reinfection of the canal system.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Root canal filling resin. Delivered via syringe with NaviTip. Class II device (Product Code KIF).

Indications for Use

Indicated for permanent obturation of root canals in secondary dentition, with or without obturation points, for patients requiring root canal treatment.

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.

Submission Summary (Full Text)

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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 [phone]. 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

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(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K042256

(Posted November 13, 2003)