PUR Waxing Sleeve RP Non-Engaging

GUDID 08415491155788

PUR Waxing Sleeve RP 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 ID08415491155788
NIH Device Record Keyd1713762-30eb-4952-bec6-6ff7b0e142c1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePUR Waxing Sleeve RP Non-Engaging
Version Model Number904784
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
GS108415491155788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08415491155788]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2017-03-06

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

08415491155788PUR Waxing Sleeve RP Non-Engaging. This product is designed to fit over the titanium post and c
00841549113628PUR Waxing Sleeve RP Non-Engaging. This product is designed to fit over the titanium post and c

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