Natural Profile Healing Abutment

GUDID 08415491016003

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 com¬plete 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 ID08415491016003
NIH Device Record Key8185f088-048e-4f90-a67c-ace71e8a5ad5
Commercial Distribution StatusIn Commercial Distribution
Brand NameNatural Profile Healing Abutment
Version Model Number904253
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
GS108415491016003 [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 Date2016-10-10

On-Brand Devices [Natural Profile Healing Abutment]

08415491043450Devices are used in dental implant applications for oral rehabilitation of edentulous and partia
08415491039750Devices are used in dental implant applications for oral rehabilitation of edentulous and partia
08415491016003Devices are used in dental implant applications for oral rehabilitation of edentulous and partia
00841549111716Devices are used in dental implant applications for oral rehabilitation of edentulous and partia
00841549110832Devices are used in dental implant applications for oral rehabilitation of edentulous and partia
00841549110733Devices are used in dental implant applications for oral rehabilitation of edentulous and partia

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