STERILE FLEXOFILE FILES AND INSTRUMENTS

K971606 · Dentsply Intl. · EFA · Jun 3, 1997 · Dental

Device Facts

• Record ID: K971606
• Device Name: STERILE FLEXOFILE FILES AND INSTRUMENTS
• Applicant: Dentsply Intl.
• Product Code: EFA · Dental
• Decision Date: Jun 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

STERILE FLEXOFILE® 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 FlexoFile® files and instruments are precision dental hand instruments used by dentists for root canal preparation. Devices are twisted from a single shaft of stainless steel to provide fracture resistance and feature non-slip plastic handles with ISO color coding for identification and preinserted silicone stops for safety. Instruments are used manually to file and shape root canals and remove necrotic tissue. The device is supplied in a compartmentalized, heat-sealed, perforated thermal adhesive strip package allowing for individual sterile access. The submission covers the transition of existing, pre-1976 exempt dental files to a sterile-marketed status via gamma irradiation, with no changes to composition or manufacturing.

Clinical Evidence

Bench testing only. Testing confirmed that gamma irradiation sterilization did not alter the mechanical properties of the files (torsion and shear stress) or the physical characteristics of the plastic handles.

Technological Characteristics

Stainless steel precision instruments; twisted shaft design; non-slip plastic handles; ISO color-coded; preinserted silicone stops. Sterilization: Gamma irradiation (Cobalt 60) per AAMI Method 1. Packaging: Compartmentalized container with heat-sealed, perforated thermal adhesive strips for individual sterile access.

Indications for Use

Indicated for use in endodontic procedures 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 FlexoFile® Files and Reamers (K943584)

Submission Summary (Full Text)

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## 510(k) SUMMARY

Image /page/0/Picture/1 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are large and closely spaced, creating a strong visual impact. The text is black against a white background, providing high contrast and readability. The overall impression is one of a clear and recognizable brand name.

## 971606

NAME & ADDRESS: 570 West College Avenue ork. PA 17405-0877 [phone] P. J. Lehn Telefax

JUN - 3 1997 CONTACT: P. Jeffery Lehn

DATE PREPARED: April 29, 1977

TRADE OR PROPRIETARY NAME: STERILE FLEXOFILE® FILES AND INSTRUMENTS

COMMON OR USUAL NAME: Files and Reamers

CLASSIFICATION NAME: Dental hand instruments 872.4565

LEGALLY MARKETED DEVICE: Presterilized FlexoFile® Files and Reamers K943584

DEVICE DESCRIPTION: FlexoFile® files and instruments are manufactured for DENTSPLY Caulk by DENTSPLY Maillefer®. They are pre-1976 medical devices and are exempt from premarket notification. However, this 510(k) submission is necessary because 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 FLEXOFILE® FILES AND INSTRUMENTS are precision instruments twisted from a single shaft of stainless steel for maximum fracture resistance. They feature preinserted silicone stops for convenience and safety. 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 stenlization, 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 FLEXOFILE® 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 FLEXOFILE® FILES AND INSTRUMENTS for the intended uses.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 3 1997

Mr. P. Jeffrey Lehn Director, Corporate Compliance and Regulatory Affairs Denstsply International -570 West College Avenue York, Pennsylvania 17405-0872

Re : K971606 Sterile Flexofile Files and Instruments Trade Name: Regulatory Class: I Product Code: EFA Dated: April 29, 1997 May 1, 1997 Received:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register.

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Page 2 - Mr. Lehn

premarket notification submission does not affect any obligation you might have under sections 531 through 542 of 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 regulation (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 [phone] or at its internet address "http://www.fda.qoy/cdrh/dsmamain.html".

Sincerely yours,

K. A. Watrud

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)

K971606

Device Name:

510(K) Number:

STERILE FLEXOFILE® 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.

(Division Sign-Off) on of Deniz!, Infer-: : rol, neral Hospital Dev 510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription User**

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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