InstaTemp® Max Temp. Material

GUDID 00841549115998

4:1 Dispensing gun

STERNGOLD DENTAL LLC

Dental material cartridge-plunging applicator, two-component, manual
Primary Device ID00841549115998
NIH Device Record Keya5b00f0f-e1a9-49fd-851b-2cdaa317733e
Commercial Distribution StatusIn Commercial Distribution
Brand NameInstaTemp® Max Temp. Material
Version Model Number220221
Company DUNS124763728
Company NameSTERNGOLD DENTAL LLC
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com
Phone508-226-5660
Emaillaura.greige@sterngold.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841549115998 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBGCrown And Bridge, Temporary, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-26
Device Publish Date2023-07-18

On-Brand Devices [InstaTemp® Max Temp. Material ]

008415491159984:1 Dispensing gun
00841549115981Mixing tips 45 pcs.

Trademark Results [InstaTemp]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INSTATEMP
INSTATEMP
97182661 not registered Live/Pending
ARC Devices Ltd.
2021-12-21
INSTATEMP
INSTATEMP
90260390 not registered Live/Pending
Sterngold Dental LLC
2020-10-16
INSTATEMP
INSTATEMP
86524930 4878622 Live/Registered
ARC Devices LTD.
2015-02-04
INSTATEMP
INSTATEMP
85724502 4328170 Live/Registered
Sterngold Dental LLC
2012-09-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.