Ortho-Ease

GUDID 00190707000684

ORTHO-EASE ETCHING SYRINGE PACK

ORTHO ORGANIZERS, INC.

Dental etching solution
Primary Device ID00190707000684
NIH Device Record Key3a289554-f0b0-4ea0-bbb6-b9e80f5f3f23
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrtho-Ease
Version Model Number470-160
Company DUNS062165188
Company NameORTHO ORGANIZERS, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100190707000684 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAGENT, TOOTH BONDING, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by ORTHO ORGANIZERS, INC.

00190707143817 - Epic2025-09-01 Epic Etch Band L6L size 10
00190707143824 - Epic2025-09-01 Epic Etch Band L6L size 11
00190707143831 - Epic2025-09-01 Epic Etch Band L6L size 12
00190707143848 - Epic2025-09-01 Epic Etch Band L6L size 13
00190707143855 - Epic2025-09-01 Epic Etch Band L6L size 14
00190707143862 - Epic2025-09-01 Epic Etch Band L6L size 15
00190707143879 - Epic2025-09-01 Epic Etch Band L6L size 16
00190707143886 - Epic2025-09-01 Epic Etch Band L6L size 17

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