ONE SHAPE APICAL 20949201

GUDID J015209492011

Endodontic instrument for professionnal dental use only

MICRO MEGA

Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use
Primary Device IDJ015209492011
NIH Device Record Key45c42b1c-8974-4575-9b50-bc01c2d5ff85
Commercial Distribution StatusIn Commercial Distribution
Brand NameONE SHAPE APICAL
Version Model NumberONE SHAPE APICAL1 n030 6% L21 Classics sterile
Catalog Number20949201
Company DUNS276075371
Company NameMICRO MEGA
Device Count5
DM Exempttrue
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ015209492010 [Unit of Use]
HIBCCJ015209492010 [Unit of Use]
HIBCCJ015209492010 [Unit of Use]
HIBCCJ015209492010 [Unit of Use]
HIBCCJ015209492010 [Unit of Use]
HIBCCJ015209492010 [Unit of Use]
HIBCCJ015209492010 [Unit of Use]
HIBCCJ015209492010 [Unit of Use]
HIBCCJ015209492010 [Unit of Use]
HIBCCJ015209492010 [Unit of Use]
HIBCCJ015209492010 [Unit of Use]
HIBCCJ015209492010 [Unit of Use]
HIBCCJ015209492010 [Unit of Use]
HIBCCJ015209492010 [Unit of Use]
HIBCCJ015209492011 [Primary]
HIBCCJ015209492011 [Primary]
HIBCCJ015209492011 [Primary]
HIBCCJ015209492011 [Primary]
HIBCCJ015209492011 [Primary]
HIBCCJ015209492011 [Primary]
HIBCCJ015209492011 [Primary]
HIBCCJ015209492011 [Primary]
HIBCCJ015209492011 [Primary]
HIBCCJ015209492011 [Primary]
HIBCCJ015209492011 [Primary]
HIBCCJ015209492011 [Primary]
HIBCCJ015209492011 [Primary]
HIBCCJ015209492011 [Primary]
HIBCCJ015209492012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209492012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209492012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209492012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209492012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209492012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209492012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209492012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209492012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209492012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209492012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209492012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209492012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209492012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution

FDA Product Code

EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
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 Date2020-07-31
Device Publish Date2020-07-23

Devices Manufactured by MICRO MEGA

J015201020011 - K FILES2020-07-31 Endodontic instruments for professionnal use only
J015201210021 - PASTINJECT2020-07-31 Endodontic instrument for professionnal dental use only
J015209492011 - ONE SHAPE APICAL2020-07-31Endodontic instrument for professionnal dental use only
J015209492011 - ONE SHAPE APICAL2020-07-31 Endodontic instrument for professionnal dental use only
J015209522011 - ONE FLARE2020-07-31 Endodontic instrument for professionnal dental use only
J015504000110 - ENDO 1500 MID MEDI2019-06-13 Dental handpiece for endontic treatment which works with Sonic vibtration

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.