BIOPURE MTAD ROOT CANAL CLEANSER

K053167 · Dentsply Intl., Inc. · KJJ · Dec 8, 2005 · DE

Device Facts

• Record ID: K053167
• Device Name: BIOPURE MTAD ROOT CANAL CLEANSER
• Applicant: Dentsply Intl., Inc.
• Product Code: KJJ · DE
• Decision Date: Dec 8, 2005
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

BIOPURE™ MTAD™ ROOT CANAL CLEANSER is used to chemically clean the canal and disinfect the root canal system after endodontic instrumentation.

Device Story

BIOPURE™ MTAD™ ROOT CANAL CLEANSER is a two-part system consisting of a liquid (Part A) and a powder (Part B). Upon mixing, the solution is applied to the root canal system by a dental professional following endodontic instrumentation. The solution functions to chemically clean the canal, remove the smear layer, and disinfect the canal by killing bacteria. It is designed to perform these functions without damaging the tooth structure or surrounding soft tissue. The device is intended for use in a clinical dental setting.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by performance and biocompatibility data.

Technological Characteristics

Two-part liquid and powder chemical cleanser. Components consist of materials previously used in legally marketed dental devices or found safe for dental use. No specific ASTM standards or software algorithms are described.

Indications for Use

Indicated for chemical cleaning and disinfection of the root canal system following endodontic instrumentation.

Predicate Devices

• EndoPure™ Root Canal Cleanser (K032361)

Submission Summary (Full Text)

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

K053167

#### DEC 8 2005

# 510(k) SUMMARY

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872

| CONTACT: | Helen Lewis |
|----------------------------|----------------------------------------|
| DATE PREPARED: | December 5, 2005 |
| TRADE OR PROPRIETARY NAME: | BIOPURE™ MTAD™ ROOT CANAL CLEANSER |
| CLASSIFICATION NAME: | Root canal cleanser, Unclassified |
| PREDICATE DEVICES: | EndoPure™ Root Canal Cleanser, K032361 |

### DEVICE DESCRIPTION:

BIOPURE™ MTAD™ ROOT CANAL CLEANSER is a two-part liquid and powder product. Part A is the liquid and Part B is the powder. The mixed solution cleanses the root canal, removes the smear layer, and kills the bacteria in an instrumented root canal without harming the tooth structure or soft tissue.

INTENDED USE:

BIOPURE™ MTAD™ ROOT CANAL CLEANSER is used to chemically clean the canal and disinfect the root canal system after endodontic instrumentation.

TECHNOLOGICAL CHARACTERISTICS:

All of the components found in BIOPURE™ MTAD™ ROOT CANAL CLEANSER have been used in legally marketed devices or were found safe for dental use. We believe that the prior use of components in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of BIOPURE™ MTAD™ ROOT CANAL CLEANSER for the indicated uses.

BIOPURE™ MTAD™ ROOT CANAL CLEANSER Premarket Notification

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or body.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 8 2005

Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

Re: K053167

K055107
Trade/Device Name: BioPure™ MTAD™ Root Canal Cleanser Regulation Number: N/A Regulation Name: Root Canal Cleanser Regulatory Class: Unclassified Product Code: KJJ Dated: November 09, 2005 Received: November 14, 2005

Dear Ms. Lewis:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your bection of the device is substantially equivalent (for the indications for referenced in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass bated in 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 nure occh footable in a mot 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 connells provized on the prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it n your device to such additional controls. Existing major regulations affecting your device can be may or store 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. Helen Lewis

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act or that 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 premated 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Juliette Y. Mcclain-Owens

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

# 14053167

510(K) Number (if known):

BIOPURE™ MTAD™ ROOT CANAL CLEANSER Device Name:

Indications for Use:

BIOPURE™ MTAD™ ROOT CANAL CLEANSER is used to chemically clean the canal and disinfect the root canal system after endodontic instrumentation.

Prescription Use _ X ___ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDEDI

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ake Russe

sion of Anesthesinlo General Hospital. Solion Control, Dental Device

Number. K53167

יין א