RP Standard Healing Abutment, 4.0mm, Ti

GUDID 08415491045003

Healing Abutments are intended for placement onto the implant during stage II surgery. As the tissue heals, it conforms to the contours of the abutment. As the gingiva heals, the tissue adapts to the form of the healing abutment, creating permanent oral access to the implant and prepares the gingiva for the restorative phase.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID08415491045003
NIH Device Record Keyf589c776-3eac-42ee-b463-792df80157f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameRP Standard Healing Abutment, 4.0mm, Ti
Version Model Number901404
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS108415491045003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2015-11-19

On-Brand Devices [RP Standard Healing Abutment, 4.0mm, Ti]

08415491045003Healing Abutments are intended for placement onto the implant during stage II surgery. As the ti
00841549107757Healing Abutments are intended for placement onto the implant during stage II surgery. As the ti

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