Stern Root Anchor® 5 Root Mini Refill Kit Ti

GUDID 08415491020765

The Stern Root AnchorSystem includes the Stern Anchor Female (Standard, Mini and casting), The Stern Anchor Male (Standard, short, oversize, extra oversize), the Stern Anchor Denture Cap. Intended to be used in attachment dentistry for stabilization and retention of removable appliances in the mouth. The 5 root kit contains-5 females, 10 white retention males, 5 transfer males, 5 caps, no bur.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID08415491020765
NIH Device Record Key3d53a719-8323-400b-bf8a-bd722dd1ea69
Commercial Distribution StatusIn Commercial Distribution
Brand NameStern Root Anchor® 5 Root Mini Refill Kit Ti
Version Model Number833085
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 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

Phone401-871-3489
Emailmaria.rao@sterngold.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108415491020765 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08415491020765]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2017-05-15

On-Brand Devices [Stern Root Anchor® 5 Root Mini Refill Kit Ti]

08415491020765The Stern Root AnchorSystem includes the Stern Anchor Female (Standard, Mini and casting), The S
00841549106729The Stern Root AnchorSystem includes the Stern Anchor Female (Standard, Mini and casting), The S

Trademark Results [Stern Root Anchor]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STERN ROOT ANCHOR
STERN ROOT ANCHOR
85352302 4151629 Live/Registered
STERNGOLD DENTAL LLC
2011-06-21

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