PUR Waxing Sleeve NP Non-Engaging

GUDID 00841549113611

PUR Waxing Sleeve NP Non-Engaging. This product is designed to fit over the titanium post and core and can easily be modified, shaped, and waxed-to to create an ideal metal support for a fixed prosthesis.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID00841549113611
NIH Device Record Keyf42b2a45-05e2-471e-874b-91262bc12644
Commercial Distribution StatusIn Commercial Distribution
Brand NamePUR Waxing Sleeve NP Non-Engaging
Version Model Number904783
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
GS100841549113611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841549113611]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-01-07
Device Publish Date2017-03-06

On-Brand Devices [PUR Waxing Sleeve NP Non-Engaging]

08415491155771PUR Waxing Sleeve NP Non-Engaging. This product is designed to fit over the titanium post and c
00841549113611PUR Waxing Sleeve NP Non-Engaging. This product is designed to fit over the titanium post and c

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