STERILE SUREFLEX FILES AND INSTRUMENTS

K971603 · Dentsply Intl. · EFA · Jun 4, 1997 · Dental

Device Facts

• Record ID: K971603
• Device Name: STERILE SUREFLEX FILES AND INSTRUMENTS
• Applicant: Dentsply Intl.
• Product Code: EFA · Dental
• Decision Date: Jun 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

STERILE SUREFLEX® FILES AND INSTRUMENTS are used to file and shape root canals and to remove necrotic tissue as a means to create a funnel-shaped cavity.

Device Story

STERILE SUREFLEX® FILES AND INSTRUMENTS are precision endodontic instruments manufactured from nickel titanium shafts. Designed for increased flexibility compared to stainless steel, they conform to curved root canal surfaces, reducing risks of apical transportation and breakage. Instruments feature non-slip plastic handles with ISO color coding for identification. Used by dentists in clinical settings to perform root canal procedures. The device is supplied in a compartmentalized container with a heat-sealed, perforated thermal adhesive strip, allowing individual access to files while maintaining the sterility of remaining units. Sterilization is achieved via gamma irradiation from a Cobalt 60 source. The device is functionally identical to the predicate, with no changes to composition or manufacturing, ensuring consistent mechanical performance in torsion and shear stress post-sterilization.

Clinical Evidence

Bench testing only. Data provided confirms that gamma irradiation sterilization does not significantly alter the mechanical behavior, torsion resistance, or shear stress of the instruments compared to non-sterilized versions. No clinical data presented.

Technological Characteristics

Nickel titanium shaft; non-slip plastic handles; ISO color-coded. Sterilization via gamma irradiation (Cobalt 60 source) validated per AAMI Method 1. Packaging consists of a compartmentalized container with a heat-sealed, perforated thermal adhesive strip for individual file access.

Indications for Use

Indicated for use by dental professionals to file and shape root canals and remove necrotic tissue to create a funnel-shaped cavity.

Regulatory Classification

Identification

A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

Predicate Devices

• Presterilized SureFlex® Files (K951607)

Submission Summary (Full Text)

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# 510(k) SUMMARY

K971603

DENTSPLY

#### NAME & ADDRESS:

#### DENTSPLY International

570 West College Avenue P.O. Box 872 York, PA 17405-0872 [phone] ax [phone]-

P. J. Lehn Telefax [phone]

CONTACT: P. Jeffery Lehn

4 1997 II IN

DATE PREPARED: April 29, 1977

TRADE OR PROPRIETARY NAME: STERILE SUREFLEX® FILES AND INSTRUMENTS

COMMON OR USUAL NAME: Files and Instruments

CLASSIFICATION NAME: Dental hand instruments 872.4565

K951607 LEGALLY MARKETED DEVICE: Presterilized SureFlex® Files

DEVICE DESCRIPTION: STERILE SUREFLEX® FILES AND INSTRUMENTS are manufactured for DENTSPL.Y Caulk by DENTSPLY Maillefer®. They are identical to the Presterilized SureFlex® files and instruments now marketed (K951607). However, DENTSPLY Caulk plans to market these devices as sterile and to revise the labeling to reflect this change. There are no changes to the composition, manufacturing process, or sterilization process.

STERILE SUREFLEX® FILES AND INSTRUMENTS are precision instruments cut from a nickel titanium shaft for increased flexibility over stainless steel instruments. They conform better to the curved surface of most root canals. They reduce the chance of apical transportation and breakage from binding in the canal. They feature non-slip plastic handles for a firmer grip, as well as ISO color coding for easy identification.

After sterilization, these files and instruments presented the same resistance in torsion and shear stress as non-sterilized instruments. No significant change in color or mechanical behavior of the plastic handles was evident following gamma irradiation.

INTENDED USE: STERILE SUREFLEX® FILES AND INSTRUMENTS are used to file and shape root canals and to remove necrotic tissue as a means to create a funnel-shaped cavity.

TECHNOLOGICAL CHARACTERISTICS: As noted above, there are no changes in the composition, manufacturing or sterilization of these files and instruments.

These files and instruments were subjected to sterilization by gamma irradiation from a Cobalt 60 source. The validation method used was AAMI Method 1.

The device package is a compartmentalized container with six (6) individually separated cells. The package includes a heat-sealed non-tearing perforated thermal adhesive strip. This strip allows for a single cell to be opened per file as required by the dentist, while all other file cells remain sealed and sterile.

We believe that the fact that the new device is identical to the predicate device, along with the sterilization data presented, supports the safety and effectiveness of STERILE SUREFLEX® FILES AND INSTRUMENTS for the intended uses.

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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 a stylized caduceus or a human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 4 1997

Mr. P. Jeffrey Lehn ·Director, Corporate Compliance and Regulatory Affairs Baxter Healthcare Corporation DENTSPLY International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872 :44

K971603 Re : Sterile Sureflex® Files and Instruments Trade Name: Requlatory Class: I Product Code: EFA Dated: April 29, 1997 Received: May 01, 1997

Dear Mr. Lehn:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Lehn

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the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at (301). 443-6597.

Sincerely yours

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## PREMARKET NOTIFICATION

### INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 801.109) .....

510(K) Number:

Device Name:

STERILE SUREFLEX® FILES AND INSTRUMENTS

Indications for Use:

Used to file and shape root canals and to remove necrotic tissue as a means to create a funnel-shaped cavity.

Susan Plassman

Concurrence of CDRH, Office of Device Evaluation (ODE) (Divisio 510k) ાર

Over-The-Counter Use __

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