S/ETCH 8100045

GUDID DO3681000451

SDI LIMITED

Dental etching solution
Primary Device IDDO3681000451
NIH Device Record Keyee7d1911-30c7-47ae-a7af-2eafdca61f5a
Commercial Distribution StatusIn Commercial Distribution
Brand NameS/ETCH
Version Model NumberS/ETCH 10X2ML SYR KT
Catalog Number8100045
Company DUNS753221852
Company NameSDI LIMITED
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
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

Customer Support Contacts

Phone+18002285166
Emailinfo@sdi.com.au

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCDO3681000450 [Unit of Use]
HIBCCDO3681000451 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMATERIAL, TOOTH SHADE, 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 Date2016-09-27

On-Brand Devices [S/ETCH]

DO3681000591S/ETCH JUMBO 2X25ML SYR
DO3681000521S/ETCH 12GM SYR WITH TIPS
DO3681000451S/ETCH 10X2ML SYR KT
DO3681000401S/ETCH 3X2ML SYR KT
DO3681000391S/ETCH 4X1.2ML SYR MINI KT

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