Natural Profile Healing Abutment 6.0mm X 4.0mm, WP, Biomain, Ti

GUDID 08415491067401

Devices are used in dental implant applications for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. 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 restoration.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID08415491067401
NIH Device Record Key9d27c5c4-8458-4ec1-bfdb-cf87a8d15590
Commercial Distribution StatusIn Commercial Distribution
Brand NameNatural Profile Healing Abutment 6.0mm X 4.0mm, WP, Biomain, Ti
Version Model Number904920
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS108415491067401 [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 Date2016-10-11

On-Brand Devices [Natural Profile Healing Abutment 6.0mm X 4.0mm, WP, Biomain, Ti]

08415491067401Devices are used in dental implant applications for oral rehabilitation of edentulous and partia
00841549114168Devices are used in dental implant applications for oral rehabilitation of edentulous and partia

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