CARRIER TIPS

K031461 · Dentsply Intl. · ELC · Aug 5, 2003 · Dental

Device Facts

• Record ID: K031461
• Device Name: CARRIER TIPS
• Applicant: Dentsply Intl.
• Product Code: ELC · Dental
• Decision Date: Aug 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Used to deliver ProRoot® MTA Material in surgical and non-surgical dental applications in conjunction with an ultrasonic unit.

Device Story

Carrier Tips are stainless steel ultrasonic tips designed for delivery of pre-mixed ProRoot® MTA material to prepared dental sites. The device consists of two tip designs (surgical and non-surgical) and a sleeve, which attach to a standard piezoelectric ultrasonic scaling unit handpiece. During endodontic procedures, the clinician uses the ultrasonic energy to facilitate the placement of the MTA material into the tooth site. Standard hand instruments are used in conjunction to condense and compact the material between placements. The device is intended for use by dental professionals in a clinical setting.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Stainless steel ultrasonic tips; piezo-electric energy source; two designs (surgical and non-surgical) with sleeve; attaches to standard ultrasonic scaling handpiece.

Indications for Use

Indicated for delivery of ProRoot® MTA material in surgical and non-surgical dental applications using an ultrasonic unit.

Regulatory Classification

Identification

An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Predicate Devices

• ProUltra® Endo and Surgical Endo Tips (K960889)

Submission Summary (Full Text)

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# AUG - 5 2003

Image /page/0/Picture/2 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and black. The word is horizontally oriented and takes up most of the image. The background is white.

NAME & ADDRESS:

O West College Avenue ). Box 877 fork, PA 17405-0872 717) 845-7511 x 17771 949 1742 w.dentsplv.com

P. J. Lehn Telefax [phone]

P. Jeffery Lehn CONTACT: MAY ( 2003 DATE PREPARED:

TRADE OR PROPRIETARY NAME: CARRIER TIPS

Accessory to ultrasonic scaler (872.4850) CLASSIFICATION NAME:

PREDICATE DEVICES: ProUltra® Endo and Surgical Endo Tips K960889

## DEVICE DESCRIPTION:

The CARRIER TIPS are stainless steel ultrasonic tips used to deliver pre-mixed ProRoot® MTA Material to a prepared dental site on the tooth and fill that site as part of an endodontic procedure. There are two tip designs - one for surgical type procedures and one for non-surgical type procedures. These tips and a sleeve are attached to a standard piezo electric ultrasonic scaling unit handpiece. In between placement of the Material, standard hand instruments are used to condense and compact the Material.

INTENDED USE: Used to deliver ProRoot® MTA Material in surgical and non-surgical dental applications in conjunction with an ultrasonic unit.

TECHNOLOGICAL CHARACTERISTICS: CARRIER TIPS are substantially equivalent to ProUltra® Endo Tips and ProUltra® Surgical Endo Tips (K960889). They have the same manufacturer, the same basic technology, the same primary energy source, and are made of the same material as the predicate devices. We believe the similarity of the CARRIER TIPS to the legally marketed predicate devices support the safety and effectiveness of the CARRIER TIPS for the indicated use.

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Image /page/1/Picture/1 description: The image is a black and white logo. The logo is circular in shape and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". In the center of the logo is a stylized image of an eagle.

Public Health Service

AUG - 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20050

Mr. P. Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872

Re: K031461

Trade/Device Name: Carrier Tips Regulation Number: 872.3820 Regulation Name: Root Canal illing Resin Regulatory Class: II Product Code: KIF, ELC Dated: May 6, 2003 Received: May 8, 2003

Dear Mr. Lehn:

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. Lehn

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]. 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 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

Enclosure

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# INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 807.87(e)

510(K) Number (if known): K031461

CARRIER TIPS Device Name:

Indications for Use:

Used to deliver ProRoot® MTA Material in surgical and non-surgical dental applications in conjunction with an ultrasonic unit.

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

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

. OR Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use ________

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Suza Rao

(Division Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Denta

510(k) Number:

7