KOMET Root Canal Files F04L31.204.055

GUDID E226044151G18

Gebr. Brasseler GmbH & Co. KG

Rotary/reciprocating endodontic file/rasp, single-use
Primary Device IDE226044151G18
NIH Device Record Key5e71efa8-a579-4a73-8908-a3e7363805ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameKOMET Root Canal Files
Version Model NumberF04L31.204.055.G1
Catalog NumberF04L31.204.055
Company DUNS317409001
Company NameGebr. Brasseler GmbH & Co. KG
Device Count6
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE226044151G11 [Primary]
HIBCCE226044151G18 [Unit of Use]

FDA Product Code

EKSFILE, PULP CANAL, ENDODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-09
Device Publish Date2023-02-01

On-Brand Devices [KOMET Root Canal Files]

E226100106048PRQ4L31.204.050.G1
E226100106028PRQ4L31.204.045.G1
E226100106008PRQ5L31.204.040.G1
E226100105988PRQ5L31.204.035.G1
E226100105968PRQ6L31.204.030.G1
E226100105948PRQ6L31.204.025.G1
E226100105928PRQ6L31.204.020.G1
E226100105908PRQ4L25.204.050.G1
E226100105888PRQ4L25.204.045.G1
E226100105868PRQ5L25.204.040.G1
E226100105848PRQ5L25.204.035.G1
E226100105828PRQ6L25.204.030.G1
E226100105808PRQ6L25.204.025.G1
E226100105788PRQ6L25.204.020.G1
E226100105768PRQ4L21.204.050.G1
E226100105738PRQ4L21.204.045.G1
E226100105688PRQ5L21.204.040.G1
E226100105648PRQ5L21.204.035.G1
E226100105628PRQ6L21.204.030.G1
E226100105608PRQ6L21.204.025.G1
E226100105588PRQ6L21.204.020.G1
E226100090778RE05L25.204.025.G1
E226100090768RE05L21.204.025.G1
E226100090758RE10L15.204.030.G1
E226100027348OPR08L19.204.025.G1
E226048921G18OP10L15.204.030.G1
E226048579G18PG03L31.204.020.G1
E226048578G18PG03L31.204.015.G1
E226048435G18OP08L19.204.025.G1
E226047492G18PG03L21.204.020.G1
E226047491G18PG03L21.204.015.G1
E226046911G18OP10L19.204.030.G1
E226046838G18PG03L25.204.020.G1
E226046802G18F06L31.204.035.G1
E226046801G18F06L25.204.035.G1
E226046800G18F06L21.204.035.G1
E226046720G18F06L31.204.040.G1
E226046719G18F06L31.204.030.G1
E226046718G18F06L31.204.025.G1
E226046717G18F06L31.204.020.G1
E226046716G18F06L25.204.040.G1
E226046715G18F06L25.204.030.G1
E226046714G18F06L25.204.025.G1
E226046713G18F06L25.204.020.G1
E226046712G18F06L21.204.040.G1
E226046711G18F06L21.204.030.G1
E226046710G18F06L21.204.025.G1
E226046709G18F06L21.204.020.G1
E226045001G18PG03L25.204.015.G1
E226044151G18F04L31.204.055.G1

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.