(79 days)
Sybron Endo, Quantec Series 2000 Endodontic File
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No
The description focuses on the mechanical properties and manufacturing process of a physical endodontic file, with no mention of software, algorithms, or data processing.
No
The device is described as an endodontic file used for root canal preparation, which is a surgical procedure to remove infected tissue and shape the canal, not to treat or cure a disease itself.
No
The device is described as an endodontic file used for root canal preparation, which is a therapeutic procedure, not a diagnostic one. It is a tool for treatment rather than for identifying a condition.
No
The device description clearly states it is a physical, engine-driven endodontic file made of nickel titanium, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The TF Rotary Nickel Titanium File is a physical instrument used within the body (specifically, in the root canal) for a mechanical procedure (root canal preparation). It does not analyze samples or provide diagnostic information based on biological markers.
The description clearly indicates it's a tool for a surgical/dental procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
The TF Rotary Nickel Titanium File is a rotary endodontic file designed for use in root canal preparation.
Product codes (comma separated list FDA assigned to the subject device)
EKS
Device Description
The TF Rotary Nickel Titanium File is an engine (rotary) driven endodontic file intended for use in root canal preparation. The TF Rotary Nickel Titanium File is made from a single bar stock of nickel titanium that is machined and formed to create a single-piece file (handle, shaft and working portion).
Flutes are ground throughout the working portion, forming the cutting edges of the instrument and creating a tapered triangular cross-section. The file blank is heat annealed and the working portion is twisted to form helical cutting edges. The file is twisted instead of ground which enhances its flexibility and durability.
The TF Rotary Nickel Titanium File has a non-cuttting (passive) tip and variable helical flute angle. The single-piece unit is intended to prevent separation of the handle from the shaft/working portion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Sybron Endo, Quantec Series 2000 Endodontic File
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4565 Dental hand instrument.
(a)
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.(b)
Classification. Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
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Section III - 510(k) Summary of Safety and Effectiveness
Submitter :
Sybron Dental Specialties, Inc. 100 Bavview Circle., Suite 6000 Newport Beach, CA 92660 (949) 255-8766 - Phone (949) 255-8763 - Facsimile
DEC 1 3 2006
Date Summary Prepared: September 2006
Colleen Boswell - Contact Person
Device Name:
- Trade Name TF Rotary Nickel Titanium File .
- . Common Name - Endodontic Pulp Canal File
- Classification Name File, Pulp Canal, Endodontic, per 21 CFR § 872.4565 .
Devices for Which Substantial Equivalence is Claimed:
- . Sybron Endo, Quantec Series 2000 Endodontic File
Device Description:
The TF Rotary Nickel Titanium File is an engine (rotary) driven endodontic file intended for use in root canal preparation. The TF Rotary Nickel Titanium File is made from a single bar stock of nickel titanium that is machined and formed to create a single-piece file (handle, shaft and working portion).
Flutes are ground throughout the working portion, forming the cutting edges of the instrument and creating a tapered triangular cross-section. The file blank is heat annealed and the working portion is twisted to form helical cutting edges. The file is twisted instead of ground which enhances its flexibility and durability.
The TF Rotary Nickel Titanium File has a non-cuttting (passive) tip and variable helical flute angle. The single-piece unit is intended to prevent separation of the handle from the shaft/working portion.
Intended Use of the Device:
The intended use of the TF Rotary Nickel Titanium File is for root canal preparation.
Substantial Equivalence:
The TF Rotary Nickel Titanium File is substantially equivalent to other legally marketed devices in the United States. The TF Rotary Nickel Titanium File functions in a manner similar to and is intended for the same use as the Quantec Series 2000 Endodontic File manufactured by Sybron Endo.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three wing-like shapes, representing health and human services. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2006
Ormco, Corporation C/O Ms. Colleen Boswell Director, Regulatory Affairs Sybron Dental Specialties, Incorporated 100 Bayview Circle, Suite 6000 Newport Beach, California 92660
Re: K062856
Trade/Device Name: TF Rotary Nickel Titanium File Regulation Number: 872.4565 Regulation Name: Dental Hand Instrument Regulatory Class: I Product Code: EKS Dated: September 22, 2006 Received: September 25, 2006
Dear Ms. Boswell:
We have reviewed vour 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 vour 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 -Ms. Boswell
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clus
Chiu Lin, Ph.D. 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
510(k) Number (if knøwn):
1062856
Device Name: TF Rotary Nickel Titanium File
Indications for Use:
The TF Rotary Nickel Titanium File is a rotary endodontic file designed for use in root canal preparation.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Punone
Ar tiesiology, General Hospital,
Control, Dental Devices
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