Product Code: EKS


Products Classified as EKS

1231File, Pulp Canal, EndodonticDental Hand Instrument.

Total Product Life Cycle (TPLC) Devices

1231File, Pulp Canal, EndodonticDental Hand Instrument.

FDA Consensus Standards

File, Pulp Canal, Endodontic [34709]21 CFR §872.4565 🔎
File, Pulp Canal, Endodontic [32013]21 CFR §872.4565 🔎
File, Pulp Canal, Endodontic [33860]21 CFR §872.4565 🔎

Pre-market Notifications for EKS

K062856TF ROTARY NICKEL TITANIUM FILEORMCO CORP.
K004031NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILESDENTAL POWER, INC.
K971319NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILESTYCOM DENTAL
K970649HERO 642MICRO-MEGA
K962031QUANTEC SERIES 2000 ENDODONTIC FILESTYCOM DENTAL
K953604SHAPING HEDSTROM N.T.SYBRON DENTAL SPECIALTIES, INC.
K935542NICKEL-TITANIUM K-TYPE FILEUNION BROACH, DIV. MOYCO INDUSTRIES, INC.
K933582PROFILE SERIES 29 FILESTULSA DENTAL PRODUCTS, LTD.
K932529LIGHTSPEED DENTAL HAND INSTRUMENTLIGHTSPEED ENDODONTICS
K905640SOLID CORE GUTTA PERCHA CARRIERTHE HYGENIC CORP.
K905461PROCEDURE KIT/ROUTINE DENTAL PROCEDURESANGIOSYSTEMS, INC.
K902018DENTAURUM CERAMIC DEBONDING UNITDENTAURAUM, INC.
K901037VISIONER 21-AJ. MORITA USA, INC.
K892894S-FILE, S-FINDER, S-ENGINE FILESVENSKA DENTAL INSTRUMENTS AB
K892861DENTAL PIKU.S. DENTEK CORP.

Global Unique Device Identification Database

00366975030443File, Pulp Canal, Endodontic
00366975015525File, Pulp Canal, Endodontic
00366975012203File, Pulp Canal, Endodontic
00366975011688File, Pulp Canal, Endodontic
00366975011671File, Pulp Canal, Endodontic
00366975011664File, Pulp Canal, Endodontic
00366975011657File, Pulp Canal, Endodontic
00366975011640File, Pulp Canal, Endodontic
00366975011633File, Pulp Canal, Endodontic
00366975011626File, Pulp Canal, Endodontic
00366975011602File, Pulp Canal, Endodontic
00366975011596File, Pulp Canal, Endodontic
00366975011589File, Pulp Canal, Endodontic
00366975011572File, Pulp Canal, Endodontic
00366975011565File, Pulp Canal, Endodontic

Maude Adverse Events

PROTAPER NEXT X1 21MMTULSA DENTAL PRODUCTS LLC2020-03-26
PROTAPER UNIVERSAL ROTARY FILE F1 25MMTULSA DENTAL PRODUCTS LLC2020-03-25
PROTAPER UNIVERSAL ROTARY FILE F1 25MMTULSA DENTAL PRODUCTS LLC2020-03-25
PROTAPER UNIVERSAL ROTARY FILE F1 25MMTULSA DENTAL PRODUCTS LLC2020-03-25
RECIPROC FILES 6XDENTSPLY VDW GMBH2020-03-24
MTWO NITI FILE 25MM, 20/.06, 16MM WORKING PART, STERILEDENTSPLY VDW GMBH2020-03-19
MTWO NITI FILE 25MM, 10/.04, 16MM WORKING PART, STERILEDENTSPLY VDW GMBH2020-03-19
MTWO NITI FILE 25MM, 15/.05, 16MM WORKING PART, STERILEDENTSPLY VDW GMBH2020-03-19
RECIPROC FILES 6XDENTSPLY VDW GMBH2020-03-19
RECIPROC FILES 6XDENTSPLY VDW GMBH2020-03-19
RECIPROC BLUE FILES, 6X, STERILEDENTSPLY VDW GMBH2020-03-14
RECIPROC BLUE FILES, 6X, STERILEDENTSPLY VDW GMBH2020-03-14
RECIPROC BLUE FILES, 6X, STERILEDENTSPLY VDW GMBH2020-03-14
PROTAPER ASSORTED 21MM *NOT CE*DENTSPLY MAILLEFER2020-03-14
RECIPROC BLUE FILES, 6X, STERILEDENTSPLY VDW GMBH2020-03-11
RECIPROC BLUE FILES, 6X, STERILEDENTSPLY VDW GMBH2020-03-11
RECIPROC FILES 6XDENTSPLY VDW GMBH2020-03-11
WAVEONE GOLD PRIMARY 6-FILE STERILE 25MMDENTSPLY MAILLEFER2020-03-11
WAVEONE GOLD PRIMARY 6-FILE STERILE 25MMDENTSPLY MAILLEFER2020-03-11
RECIPROC BLUE FILES, 6X, STERILEDENTSPLY VDW GMBH2020-03-11
RECIPROC BLUE FILES, 6X, STERILEDENTSPLY VDW GMBH2020-03-11
PROFILE NT ROTARY INSTRUMENT 25/.04 30MMTULSA DENTAL PRODUCTS LLC2020-03-11
WAVEONE GOLD RECIPROCATING FILE PRIMARY 25MMTULSA DENTAL PRODUCTS LLC2020-03-11
WAVEONE GOLD RECIPROCATING FILE PRIMARY 25MMTULSA DENTAL PRODUCTS LLC2020-03-11
PROTAPER UNIVERSAL ROTARY FILE S1 21MMTULSA DENTAL PRODUCTS LLC2020-03-11
PROGLIDER 6FILE STERILE 25MMDENTSPLY MAILLEFER2020-03-11
WAVEONE GOLD RECIPROCATING FILE SMALL 21MMTULSA DENTAL PRODUCTS LLC2020-03-11
RECIPROC BLUE FILES, 6X, STERILEDENTSPLY VDW GMBH2020-03-02
PROTAPER UNIVERSAL ROTARY FILE S2 25MMTULSA DENTAL PRODUCTS LLC2020-03-02
PROTAPER UNIVERSAL ROTARY FILE F2 25MMTULSA DENTAL PRODUCTS LLC2020-03-02
PROTAPER UNIVERSAL ROTARY FILE F1 25MMTULSA DENTAL PRODUCTS LLC2020-03-02
K-REAMERS, CC+, STERILEDENTSPLY VDW GMBH2020-02-27
RECIPROC BLUE FILES, 6X, STERILEDENTSPLY VDW GMBH2020-02-27
WAVEONE GOLD PRIMARY 6-FILE STERILE 25MMDENTSPLY MAILLEFER2020-02-27
RECIPROC BLUE FILES, 6X, STERILEDENTSPLY VDW GMBH2020-02-27
C-PILOT FILES, CC+, STERILEDENTSPLY VDW GMBH2020-02-27
PROFILE VORTEX BLUE 06/20 25MMTULSA DENTAL PRODUCTS LLC2020-02-27
RECIPROC BLUE FILES, 6X, STERILEDENTSPLY VDW GMBH2020-02-27
RECIPROC FILES 6XDENTSPLY VDW GMBH2020-02-27
RECIPROC BLUE FILES, 6X, STERILEDENTSPLY VDW GMBH2020-02-27
VDW ROTATE FILEDENTSPLY VDW GMBH2020-02-23
RECIPROC BLUE FILES, 6X, STERILEDENTSPLY VDW GMBH2020-02-22
WAVEONE GOLD PRIMARY 6-FILE STER 31MMDENTSPLY MAILLEFER2020-02-19
UNKNOWNDENTSPLY VDW GMBH2020-02-13
RECIPROC BLUE FILES, 6X, STERILEDENTSPLY VDW GMBH2020-02-13
RECIPROC FILES 6XDENTSPLY VDW GMBH2020-02-12
RECIPROC FILES 6XDENTSPLY VDW GMBH2020-02-12
PROTAPER GOLD F3 25MM STERDENTSPLY MAILLEFER2020-02-07
PROTAPER NEXT NITIFILE X1 25MMDENTSPLY MAILLEFER2020-02-06
WAVEONE GOLD RECIPROCATING FILE PRIMARY 25MMTULSA DENTAL PRODUCTS LLC2020-02-06
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