SMEARCLEAR

K024198 · Sybron Dental Specialties, Inc. · KJJ · Mar 5, 2003 · DE

Device Facts

• Record ID: K024198
• Device Name: SMEARCLEAR
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: KJJ · DE
• Decision Date: Mar 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

SmearClear is a cleaning solution designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation.

Device Story

SmearClear is an endodontic irrigating solution used by dental professionals during root canal procedures. The solution is applied to the root canal to facilitate the removal of dentinal debris from the canal walls before the obturation process. By cleaning the canal walls, the device assists in preparing the site for final filling, potentially improving the quality of the root canal seal.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endodontic irrigating solution. Chemical composition and specific material standards are not detailed in the provided documentation.

Indications for Use

Indicated for the removal of dentinal debris from root canal walls prior to obturation in patients undergoing endodontic procedures.

Predicate Devices

• PulpDent's EDTA Solution

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image is a logo for Sybron Dental Specialties. The logo features the letters "sds" in a stylized font, with a curved line above the letters. Below the letters, the words "SYBRON DENTAL SPECIALTIES" are written in a serif font. The logo is black and white.

MAR 0 5 2003

# KO24198

## Section III - 510(k) Summary of Safety and Effectiveness

## Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 [phone] - Phone [phone] - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: December 2002

#### Device Name:

- Trade Name SmearClear .
- Common Name Endodontic Irrigating Solution .
- Classification Name Root Canal Cleanser .

# Devices for Which Substantial Equivalence is Claimed:

- PulpDent Corporation, PulpDent's EDTA Solution .
#### Device Description:

SmearClear is a cleaning solution designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation.

#### Intended Use of the Device:

The intended use of SmearClear is designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation.

#### Substantial Equivalence:

Smear Clear is substantially equivalent to other legally marketed devices in the United States. SmearClear functions in a manner similar to and is intended for the same use as PulpDent's EDTA Solution manufactured by PulpDent Corporation.

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

Image /page/1/Picture/11 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge of the circle. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 5 2003

Ms. Colleen Boswell Director, Corporation Compliance Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867

Re: K024198

Trade/Device Name: SmearClear Regulation Number: Unclassified Regulation Name: Root Canal Cleanser Regulatory Class: Unclassified Product Code: KJJ Dated: December 18, 2002 Received: December 20, 2002

Dear Ms. Boswell:

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 – Ms. Colleen Boswell

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 Roanes

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

Enclosure

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

#### Section I

# Indications for Use Statement

Ver/3-4/24/96

Applicant: Sybron Endo, a division of Ormco Corporation

| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|-------------------------|
| 510(k) Number (if known): | K024198 |
| Device Name: | SmearClear |

Indications For Use:

SmearClear is a cleaning solution designed to facilitate removal of dentinal debris from the
walls of root canals prior to obturation.

Ken Muky for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

| <strong>Labels</strong> | <strong>Values</strong> |
|-------------------------|-------------------------|
| 510(k) Number. | K024198 |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)
(Optional Format 1-2-96)