ENDOREZ

K992097 · Ultradent Products, Inc. · KIF · Oct 26, 1999 · Dental

Device Facts

• Record ID: K992097
• Device Name: ENDOREZ
• Applicant: Ultradent Products, Inc.
• Product Code: KIF · Dental
• Decision Date: Oct 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

EndoREZ is used for permanent obturation of root canals of the secondary dentition with or without the use of obturation points. It is easily delivered to the canal with a small Endo-Eze tip. When mixed and placed, it flows into the canal, eliminating or minimizing air entrapment.

Device Story

EndoREZ is a root canal sealer used by dentists for permanent obturation of secondary dentition. The device is delivered into the root canal using a small Endo-Eze tip. The material flows into the canal space to fill voids and minimize air entrapment, providing a seal for the root canal system. It may be used in conjunction with traditional obturation points or as a standalone sealer. The device facilitates the clinical objective of achieving a hermetic seal in endodontic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Root canal sealer composed of UDMA (Urethane Dimethacrylate) resin. Delivered via small Endo-Eze tip. Designed for flowability to minimize air entrapment during placement.

Indications for Use

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

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 26 1999

Mr. Scott E. Moore Regulatory Affairs Manager Ultradent Products, Inc. 505 West 10200 South South Jordan, Utah 84095

K992097 Re : Trade Name: EndoRez Root Canal Sealer Regulatory Class: II Product Code: KIF September 21, 1999 Dated: Received: September 28, 1999

Dear Mr. Moore:

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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Ms. Moore

obligation you might have under sections 531 through 542 of obligation you magne mark 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 described in your Slovky picmazio of your device to a legally
finding of substantial equivalence of alsacification for your Finding of Subscancial equirastission a classification for your marketed predicate device bur 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 regaradiagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on compreance at (50) devertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CRR 807.97). Other general premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obcarned from one [phone] or [phone] 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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510(k) Number (if known):

EndoREZ UDMA Root Canal Sealer Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

EndoREZ is used for permanent obturation of root canals of the secondary dentition with or without EndoREZ is used for permation of toot canals with a small Endo-Eze tip. When mixed and the and of obturation points. It is easily delivered to the unal ment, eliminating or minimizing air entrapment.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices, 510(k) Number .