ROK 8500011

GUDID DO3685000111

SDI LIMITED

Dental pit/fissure sealant
Primary Device IDDO3685000111
NIH Device Record Keyfec2878a-8e66-481f-aea7-86f683b11254
Commercial Distribution StatusIn Commercial Distribution
Brand NameROK
Version Model NumberROK 1 SYR C2
Catalog Number8500011
Company DUNS753221852
Company NameSDI LIMITED
Device Count1
DM Exemptfalse
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 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
HIBCCDO3685000111 [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 Date2016-09-30

On-Brand Devices [ROK]

DO3685001011ROK SHADE GUIDE 5 SYR KT
DO3685001001ROK SYR INTRO KT
DO3685000111ROK 1 SYR C2
DO3685000071ROK 1 SYR B2
DO3685000061ROK 1 SYR B1
DO3685000041ROK 1 SYR A3.5
DO3685000031ROK 1 SYR A3
DO3685000021ROK 1 SYR A2

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