(11 days)
Not Found
No
The summary describes a mechanical endodontic file system and makes no mention of AI or ML.
No.
The device is a tool used for root canal preparation, which is a therapeutic procedure, but the files themselves are instruments and not a therapeutic device designed to treat a condition directly through energy, substance, or other therapeutic action.
No
The device is described as endodontic files used for root canal preparation, which is a treatment procedure, not a diagnostic one.
No
The device description clearly states that the device is a series of hand and engine-driven endodontic files constructed of nickel-titanium, which are physical hardware components.
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.
- Device Function: The Quantec Series 2000 Endodontic Files are instruments used within the body (specifically, in the root canal) for a physical procedure (root canal preparation). They are not used to analyze samples taken from the body.
The description clearly indicates a surgical/dental instrument used for a physical procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Quantec Series 2000 Endodontic Files are designed for use in root canal preparation.
Product codes
Not Found
Device Description
The Quantec Series 2000 Endodontic Files are a series hand driven and engine (rotary) driven endodontic files for use in root canal preparation. The files are constructed of nickel-titanium and color coded for ease of use. The files are available in 17, 21 and 25mm lengths and ten graduating sizes.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
JUN - 4 1996
ﻧﺰﺭ . ﻓﺄﻧﺎ :
SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 15:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
15.1 SUBMITTER INFORMATION
| a. | Company Name: | Tycom Dental |
|---|---|---|
| b. | Company Address: | 17802 Fitch Avenue |
| Irvine, CA 92714 | ||
| c. | Company Phone: | (714) 955-0800 |
| d. | Contact Person: | Patrick Johnson |
| General Manager | ||
| Tycom Dental | ||
| e. | Date Summary Prepared: | May 20, 1996 |
15.2. DEVICE IDENTIFICATION
| a. | Trade/Proprietary Name: | Quantec Series 2000 Endodontic File |
|---|---|---|
| b. | Classification Name(s): | IntraOral Dental Drill |
| Dental Hand Instrument |
15.3 IDENTIFICATION OF PREDICATE DEVICE
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Tulsa Dental | Profile 29 Series | K933582 | 10/20/93 |
| Dentsply | SureFlex Endodontic | ||
| Files | K943584 | 09/21/94 |
1
15.4 DEVICE DESCRIPTION
The Quantec Series 2000 Endodontic Files are a series hand driven and engine (rotary) driven endodontic files for use in root canal preparation. The files are constructed of nickel-titanium and color coded for ease of use. The files are available in 17, 21 and 25mm lengths and ten graduating sizes.
15.5 SUBSTANTIAL EQUIVALENCE
The Quantec Series 2000 Endodontic hand files are substantially equivalent to the Tulsa Dental Profile 29 Series hand files and the Dentsply SureFlex Endodontic Files in terms of intended use and technological characteristics. The Quantec Series 2000 Endodontic engine files are substantially equivalent to the Tulsa Dental Profile 29 Series engine files in terms of intended use and technological characteristics.
The fundamental characteristics of the device are similar to those of the predicate devices and are listed on the comparison charts provided in this 510(k) submission.
INTENDED USE ાર્સ્વ
The Quantec Series 2000 Endodontic Files are designed for use in root canal preparation.
15.7 TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the predicate and legally marketed devices is provided in this submission.
15.8 510(K) CHECKLIST
This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.