PERMITE 4001101

GUDID DO3640011012

SDI LIMITED

Dental amalgam alloy
Primary Device IDDO3640011012
NIH Device Record Keya50de3fb-7111-4d0f-a996-f888c1a8a3a7
Commercial Distribution StatusIn Commercial Distribution
Brand NamePERMITE
Version Model NumberPERMITE 1SP ECT 50
Catalog Number4001101
Company DUNS753221852
Company NameSDI LIMITED
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
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

Customer Support Contacts

Phone+18002285166
Emailinfo@sdi.com.au

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCDO3640011010 [Unit of Use]
HIBCCDO3640011012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EJJAlloy, amalgam

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 Date2016-09-23

On-Brand Devices [PERMITE]

DO3640603032PERMITE ALLOY REG 5OZ
DO3640602022PERMITE ALLOY FAST 5OZ
DO3640503032PERMITE TABS REG 5OZ
DO3640502022PERMITE TABS FAST 5OZ
DO3640250002PERMITE 5SP 500
DO3640234042PERMITE 3SP SLOW 500
DO3640233032PERMITE 3SP REG 500
DO3640232022PERMITE 3SP FAST 500
DO3640231012PERMITE 3SP ECT 500
DO3640224642PERMITE 2SP SC 500
DO3640224042PERMITE 2SP SLOW 500
DO3640223032PERMITE 2SP REG 500
DO3640222022PERMITE 2SP FAST 500
DO3640221012PERMITE 2SP ECT 500
DO3640214042PERMITE 1SP SLOW 500
DO3640213032PERMITE 1SP REG 500
DO3640212022PERMITE 1SP FAST 500
DO3640211012PERMITE 1SP ECT 500
DO3640050002PERMITE 5SP REG 50
DO3640034642PERMITE 3SP SC 50
DO3640034042PERMITE 3SP SLOW 50
DO3640033032PERMITE 3SP REG 50
DO3640032022PERMITE 3SP FAST 50
DO3640031012PERMITE 3SP ECT 50
DO3640024642PERMITE 2SP SC 50
DO3640024042PERMITE 2SP SLOW 50
DO3640023032PERMITE 2SP REG 50
DO3640022022PERMITE 2SP FAST 50
DO3640021012PERMITE 2SP ECT 50
DO3640014042PERMITE 1SP SLOW 50
DO3640013032PERMITE 1SP REG 50
DO3640012022PERMITE 1SP FAST 50
DO3640011012PERMITE 1SP ECT 50

Trademark Results [PERMITE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PERMITE
PERMITE
73165931 1163331 Live/Registered
Southern Dental Industries
1978-04-11

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