QUANTEC SERIES 2000 ENDODONTIC FILES

K962031 · Tycom Dental · EKS · Jun 4, 1996 · Dental

Device Facts

• Record ID: K962031
• Device Name: QUANTEC SERIES 2000 ENDODONTIC FILES
• Applicant: Tycom Dental
• Product Code: EKS · Dental
• Decision Date: Jun 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4565
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Quantec Series 2000 Endodontic Files are designed for use in root canal preparation.

Device Story

Quantec Series 2000 Endodontic Files; hand-driven or engine-driven (rotary) instruments; used for root canal preparation; constructed of nickel-titanium; color-coded; available in 17, 21, and 25mm lengths with ten graduating sizes; operated by dental professionals in clinical settings; facilitates mechanical cleaning and shaping of root canal systems.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design comparison to legally marketed predicate devices.

Technological Characteristics

Nickel-titanium construction; hand or rotary engine-driven; 17, 21, 25mm lengths; ten graduating sizes; color-coded for identification.

Indications for Use

Indicated for root canal preparation in patients requiring endodontic treatment.

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.

Predicate Devices

• Tulsa Dental Profile 29 Series (K933582)
• Dentsply SureFlex Endodontic Files (K943584)

Submission Summary (Full Text)

{0}

JUN - 4 1996
K96a03)

# SECTION 15: SUMMARY OF SAFETY AND EFFECTIVENESS

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: [phone]
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 |

00000

{1}

000100

## 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.

## 15.6 INTENDED USE

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.