ACROSEAL ROOT CANAL OR APICAL SEALER

K023976 · Septodont S.A.S. · KIF · Jan 30, 2003 · Dental

Device Facts

• Record ID: K023976
• Device Name: ACROSEAL ROOT CANAL OR APICAL SEALER
• Applicant: Septodont S.A.S.
• Product Code: KIF · Dental
• Decision Date: Jan 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Permanent canal filling

Device Story

ACROSEAL is a root canal sealer used by dentists during endodontic procedures. It functions as a filling material to seal the root canal system permanently. The device is applied by a clinician to fill the space within the root canal, preventing leakage and promoting a successful seal. It is intended for prescription use only.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review.

Technological Characteristics

Root canal filling resin; Class II device; 21 CFR 872.3820(b)(1).

Indications for Use

Indicated for permanent root canal filling in patients requiring endodontic 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

JAN 3 0 2003

·Septodont S.A.S. C/O Wayne H. Matelski, Esq. Arent Fox Kintner Plotkin & Kahn, PLLC 1050 Connecticut Avenue, NW Washington, DC 20036-5339

Re: K023976

Trade/Device Name: ACROSEAL Root Canal Sealer Regulation Number: 21 CFR 872.3820(b)(1) Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: November 25, 2002 Received: November 27, 2002

Dear Mr. Matelski:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device 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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Wayne H. Matelski, Esq.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) 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), 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runner

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

Page ________ of

510(k) Number (if known): - 4022514 (which FDA has now converted to K023976)

ACROSEAL Root Canal or Apical Sealer Device Name:

Indications for Use: Permanent canal filling

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

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

OR

Over-the-Counter Use

(Optional Format 1-2-96)

Kee Muluy for MSA

(Division Sign-Off) (Division Sign-O"), General Hospital, Infection Control, Dental Devices

510(k) Number. K023916