ENDOSOLV E

K980633 · Specialites Septodont · KIF · May 1, 1998 · Dental

Device Facts

• Record ID: K980633
• Device Name: ENDOSOLV E
• Applicant: Specialites Septodont
• Product Code: KIF · Dental
• Decision Date: May 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Softening and removal of root canal fillings

Device Story

ENDOSOLV E is a chemical agent used by dentists during endodontic procedures. It is applied to root canal fillings to soften the material, facilitating its mechanical removal by the clinician. The device is used in a clinical setting to assist in the retreatment of root canals. By softening the filling material, it aids the practitioner in clearing the canal, thereby supporting successful endodontic revision and potentially improving patient outcomes by allowing for proper cleaning and re-filling of the root canal system.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Chemical solvent for endodontic filling materials. Formulated for professional dental use. No electronic, software, or mechanical components.

Indications for Use

Indicated for the softening and removal of root canal fillings in patients requiring endodontic retreatment.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 1008 MAY

Specialites Septodont C/O Mr. Peter S. Reichertz Counsel for Specialites Septodont Arent Fox 1050 Connecticut Avenue, NW Washington, DC 20036-5339

Re : K980633 Trade Name: ENDOSOLV E Regulatory Class: II Product Code: KIF Dated: February 18, 1998 Received: February 19, 1998

Dear Mr. Reichertz:

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. A ... ... 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 regulation may result in regulatory 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 obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Reichertz

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 deborized in your four 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 diagnostic 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.fdaygov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Directbr 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) Nunber (if known):

ENDOSOLV E Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Softening and removal of root canal fillings

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NERDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Benson

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

**Prescription Use**
X
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

.

(Optional Format 1-2-96)

02/13 '96 11:07