Atlas FDA

EKS

31 FDA 510(k) clearances · Product code

57 daysmedian time to decision
161 days90th percentile
31clearances measured

FDA profile

Official device name
File, Pulp Canal, Endodontic
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Medical specialty
Dental
Adverse events (MAUDE)
2021: 342 · 2022: 291 · 2023: 264 · 2024: 313 · 2025: 330 · 2026: 213
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
TF ROTARY NICKEL TITANIUM FILE (K062856)Ormco Corp.2006-12-13
NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES (K004031)Dental Power, Inc.2001-03-28
NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES (K971319)Tycom Dental1997-05-22
HERO 642 (K970649)Micro-Mega1997-05-16
QUANTEC SERIES 2000 ENDODONTIC FILES (K962031)Tycom Dental1996-06-04
SHAPING HEDSTROM N.T. (K953604)Sybron Dental Specialties, Inc.1995-09-28
NICKEL-TITANIUM K-TYPE FILE (K935542)Union Broach, Div. Moyco Industries, Inc.1994-01-03
LIGHTSPEED DENTAL HAND INSTRUMENT (K932529)Lightspeed Endodontics1993-11-04
PROFILE SERIES 29 FILES (K933582)Tulsa Dental Products, Ltd.1993-10-20
DENTAURUM CERAMIC DEBONDING UNIT (K902018)Dentauraum, Inc.1991-04-03
SOLID CORE GUTTA PERCHA CARRIER (K905640)The Hygenic Corp.1991-03-05
PROCEDURE KIT/ROUTINE DENTAL PROCEDURES (K905461)Angiosystems, Inc.1991-03-05
VISIONER 21-A (K901037)J. Morita USA, Inc.1990-08-14
A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) (K897195)A Company, Inc.1990-05-31
DE-BOND 200 (K883418)Scheu-Dental1989-10-24
DENTAL PIK (K892861)U.S. Dentek Corp.1989-09-15
S-FILE, S-FINDER, S-ENGINE FILE (K892894)Svenska Dental Instruments AB1989-05-24
COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM (K873671)Coltene, Inc.1987-10-27
SOLUSET CALCIUM DEMINERALIZING SOLUTION (K864976)Endo Technic Corp.1987-02-27
DENTAL HANDPIECES AND ATTACHMENT (K864922)E&D Dental Manufacturing Co.1987-02-19
ENDOBRUSH (K870177)C & S Microinstruments , Ltd.1987-02-19
FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE (K855136)Union Broach, Div. Moyco Industries, Inc.1986-03-06
FILE TYPE K ENDODONTIC (K823684)United Dental Mfg., Inc.1982-12-28
FILE TYPE H (HEDSTROEM) ENDODONTIC (K823685)United Dental Mfg., Inc.1982-12-28
DENTAL INSTRUMENTS - FILES (K823316)Miltex, Inc.1982-11-24
DENTAL INSTRUMENTS - EXCAVATORS (K823318)Miltex, Inc.1982-11-24
ROOT CANAL FILES, TYPE H (HEDSTROM (K822622)Union Broach, Div. Moyco Industries, Inc.1982-09-28
ROOT CANAL FILES, TYPE K (K822621)Union Broach, Div. Moyco Industries, Inc.1982-09-28
FILES & REAMERS (K812692)Miltex Instrument Co.1981-10-23
DYNA TRAK ENDODONTIC PREP. INSTRUMENT (K812260)Inventive Technology Int'L., Inc.1981-08-25
FILE, PULP CANAL (K800293)Ipco Corp.1980-02-19

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Every clearance here is in the API, with alerts when new ones post.