ENDO-SEAL

K971899 · Ultradent Products, Inc. · KIF · Jun 26, 1997 · Dental

Device Facts

• Record ID: K971899
• Device Name: ENDO-SEAL
• Applicant: Ultradent Products, Inc.
• Product Code: KIF · Dental
• Decision Date: Jun 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

EndoSeal is a dental root canal sealer; delivered to root canals using Endo-Eze 31 gauge or capillary tips. Used in conjunction with the SpaTwist System; allows direct placement to the bottom of the root; enables bottom-up filling to eliminate air entrapment. Eliminates the need for gutta percha points. Used by dental professionals in a clinical setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Root canal sealer material; delivered via 31 gauge or capillary tips; used with SpaTwist delivery system.

Indications for Use

Indicated for use as a root canal sealer in dental procedures. No specific patient population or contraindications provided.

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

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [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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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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