FLARE,FILE, FILL

K981234 · Lone Star Technologies · EJB · Jun 5, 1998 · Dental

Device Facts

• Record ID: K981234
• Device Name: FLARE,FILE, FILL
• Applicant: Lone Star Technologies
• Product Code: EJB · Dental
• Decision Date: Jun 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4565
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

For use in the preparation of root canals prior to the final filling of the root canals in adult or deciduous teeth. The Dentist or Endodontist examines the patient to determine if the method of treatment is to be the removal of the root canal for the appropriate reasons. After opening the tooth with the access bur the first part of the root canal is exposed to the point where the canals tend to branch out about one third of the way. The Dentist then follows his standard procedure of locating the Apex and removal of the nerve and decayed matter from the canal using the Flare--File -- Fill procedures.

Device Story

Flare--File--Fill is a dental instrument system used by dentists or endodontists for root canal preparation. The device facilitates the removal of nerve and decayed matter from the root canal system. The procedure involves accessing the tooth with a bur, exposing the canal to the branching point, and performing mechanical cleaning and shaping of the canal. The device assists in the standard clinical workflow of locating the apex and clearing the canal prior to final filling. It is intended for professional use in a clinical setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical dental instrumentation system for root canal preparation. No electronic, software, or energy-based components described.

Indications for Use

Indicated for preparation of root canals in adult or deciduous teeth prior to final filling. Used by dentists or endodontists for removal of nerve and decayed matter from root canals.

Regulatory Classification

Identification

A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.

Submission Summary (Full Text)

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Image /page/0/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold line drawing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 1998 JUN

Mr. Edward Spehar · Lone Star Technologies® (LST) 31 Runnymeade Road Chatham, New Jersey 07928

Re : K981234 Trade Name: Flare, File, Fill Regulatory Class: I Product Code: EJB March 31, 1998 Dated: Received: April 4, 1998

Dear Mr. Spehar:

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 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). 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Spehar

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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" (21CFR 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours, SUZER Supper

CyTimothy 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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Page 12 of 13

| 510(k) Number (if known): | None Issued Yet |
|---------------------------|-------------------|
| Device Name: | Flare--File--Fill |

Indications For Cor Corp:

For use in the preparation of root canals prior to the final filling of the root canals in adult or deciduous teeth. The Dentist or Endodontist examines the patient to determine if the method of treatment is to be the removal of the root canal for the appropriate reasons. After opening the tooth with the access bur the first part of the root canal is exposed to the point where the canals tend to branch out about one third of the way. The Dentist then follows his standard procedure of locating the Apex and removal of the nerve and decayed matter from the canal using the Flare--File -- Fill procedures.

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Division of Dental, Infection Control, and General Hospital, Intection 510(k) Number

Prescription Use
(Per 21 CFR 801.109)
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Over-The-Counter Use

(Optional Format 1-2-96)