ERA Std. Ovd. Impression Coping

GUDID 00841549116285

Std. Ovd. Impression Coping

STERNGOLD DENTAL LLC

Dental implant abutment impression cap Dental implant abutment impression cap Dental implant abutment impression cap Dental implant abutment impression cap Dental implant abutment impression cap Dental implant abutment impression cap Dental implant abutment impression cap Dental implant abutment impression cap Dental implant abutment impression cap Dental implant abutment impression cap Dental implant abutment impression cap Dental implant abutment impression cap Dental implant abutment impression cap Dental implant abutment impression cap Dental implant abutment impression cap Dental implant abutment impression cap Dental implant abutment impression cap
Primary Device ID00841549116285
NIH Device Record Key0bc02155-491a-4ba3-a575-38da90ab1547
Commercial Distribution StatusIn Commercial Distribution
Brand NameERA Std. Ovd. Impression Coping
Version Model Number811233
Company DUNS124763728
Company NameSTERNGOLD DENTAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 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
Phone508-226-5660
Emaillaura.greige@sterngold.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841549116285 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841549116285]

Moist Heat or Steam Sterilization


[00841549116285]

Moist Heat or Steam Sterilization


[00841549116285]

Moist Heat or Steam Sterilization


[00841549116285]

Moist Heat or Steam Sterilization


[00841549116285]

Moist Heat or Steam Sterilization


[00841549116285]

Moist Heat or Steam Sterilization


[00841549116285]

Moist Heat or Steam Sterilization


[00841549116285]

Moist Heat or Steam Sterilization


[00841549116285]

Moist Heat or Steam Sterilization


[00841549116285]

Moist Heat or Steam Sterilization


[00841549116285]

Moist Heat or Steam Sterilization


[00841549116285]

Moist Heat or Steam Sterilization


[00841549116285]

Moist Heat or Steam Sterilization


[00841549116285]

Moist Heat or Steam Sterilization


[00841549116285]

Moist Heat or Steam Sterilization


[00841549116285]

Moist Heat or Steam Sterilization


[00841549116285]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-13
Device Publish Date2023-10-05

Devices Manufactured by STERNGOLD DENTAL LLC

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00841549119170 - MOR2024-04-22 Comfort Cap 4 pack
00841549118289 - Platinum Foil 1 DWT 2023-10-16 92mm x 32mm x .02 mm thick
00841549108280 - MOR®-A Implant2023-10-13 3.0 x 10mm, Ti
00841549108297 - MOR®-A Implant2023-10-13 3.0 x 13mm, Ti
00841549108303 - MOR®-A Implant2023-10-13 3.0 x 15mm, Ti
00841549108310 - MOR®-A Implant2023-10-13 3.0 x 18mm, Ti
00841549115707 - TRU®/PUR® Surgical Kit 2023-10-13

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