GUTTAFLOW

K032662 · Coltene/Whaledent GmbH & Co. KG · KIF · Nov 3, 2003 · Dental

Device Facts

• Record ID: K032662
• Device Name: GUTTAFLOW
• Applicant: Coltene/Whaledent GmbH & Co. KG
• Product Code: KIF · Dental
• Decision Date: Nov 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GuttaFlow is a material for permanent obturation of root canals after vital extirpation and after treatment of pulpal gangrene and temporary filling of the canal.

Device Story

GuttaFlow is a permanent root canal filling material used by dentists in clinical settings. It is a silicone-based (polydimethylsiloxane) material containing gutta-percha, zinc oxide, zirconium dioxide, paraffin-based oil, silicone oil, hexachloroplatinic acid, and silicic acid. The device functions as an obturation material to seal root canals. It is applied by the clinician during endodontic procedures to fill the canal space. The material is non-resorbable and provides dimensional stability and flow characteristics suitable for root canal sealing.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and material composition comparisons.

Technological Characteristics

Silicone-based (polydimethylsiloxane) root canal filling material. Composition includes gutta-percha, zinc oxide, zirconium dioxide, paraffin-based oil, silicone oil, hexachloroplatinic acid, and silicic acid. Non-resorbable. Class II device (21 CFR 872.3820).

Indications for Use

Indicated for permanent obturation of root canals following vital extirpation or treatment of pulpal gangrene, and for temporary filling of the root canal.

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.

Predicate Devices

• RoekoSeal (K973539)

Submission Summary (Full Text)

{0}------------------------------------------------

K032662

OV = 3 2003

coltène
whaledent

510(k) Submission GuttaFlow 510 (K) STATEMENT ( Summary ) (As required by 21 CFR 807.93)

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21CFR § 807.92.

- 1. GuttaFlow is a Class II, permanent root canal filling material.
- 2. GuttaFlow is substantially equivalent to RoekoSeal-K973539 which is also manufactured and distributed by Coltène/Whaledent.GmbH + Co. KG.
- 3. GuttaFlow is silicone based (Polydimethysiloxane) and consists additionally of Gutta Percha, Zinc oxide, Zircondioxide, paraffin-based oil, silicone oil, hexachloroplatinic acid, and silicic acid.
- 4. The technical characteristics of Gutta Flow are similar to those of the predicate device RoekoSeal which is also silicone based. Dimension stability, flow, film thickness, biocompatibility and solubility are very similar for both materials. Differences are primarily in the GuttaFlow curing time and the addition of Gutta Percha and Zinc oxide.
- 5. GuttaFlow and RoekoSeal are not resorbable.

(Signature)

H. Vogelstein

N/A
Date 20 August 2013

Official Correspondent &
US @gent

(Premarket Notification [510(k)]Number)

380-12

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes above its head, symbolizing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Public Health Service

NOV - 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Coltene/Whaledent GmbH & Company KG C/O Mr. Henry J. Vogelstein Consultant Coltene/Whaledent, Incorporated 235 Ascot Parkway Cuyahoga Falls, Ohio 44223

Re: K032662

Trade/Device Name: GuttaFlow Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Codes: KIF and EKM Dated: August 22, 2003 Received: August 28, 2003

Dear Mr. Vogelstein:

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.

{2}------------------------------------------------

## Page 2 -- Mr. Henry J. Vogelstein

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 (OS) 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 vours.

Patricia Cucenttfor

Chiu S. Lin. PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## Indications for Use

Page 1 of

14032662 510(k) Number (if known):

Device Name: GuttaFlow

Indications for Use:

GuttaFlow is a material for permanent obturation of root canals after vital extirpation and after treatment of pulpal gangrene and temporary filling of the canal.

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

Prescription Use V (Per 21 CFR 801.109)

OR Over-the-Counter Use
Suser Runo

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

510(k) Number: K033662