RP Natural Profile Abutment 5.0mm x 3.0mm

GUDID 00841549110627

The RP Natural Profile Abutment enables the clinician to restore cases that are periodontally and aesthetically demanding. This versatile system permits the development of an emergence profile which is in harmony with the soft tissue. Final margination can be prepared to accurately follow the gingival contours in order to achieve maximum aesthetics. Intended for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws directly into endosseous implants or they screw into Abutment Bases which are screwed into endosseous implants.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID00841549110627
NIH Device Record Key4ba13e1a-b436-4879-820b-ead94cfbfa46
Commercial Distribution StatusIn Commercial Distribution
Brand NameRP Natural Profile Abutment 5.0mm x 3.0mm
Version Model Number904242
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
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com
Phone401-871-3489
Emailmaria.rao@sterngold.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841549110627 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841549110627]

Moist Heat or Steam Sterilization


[00841549110627]

Moist Heat or Steam Sterilization


[00841549110627]

Moist Heat or Steam Sterilization


[00841549110627]

Moist Heat or Steam Sterilization


[00841549110627]

Moist Heat or Steam Sterilization


[00841549110627]

Moist Heat or Steam Sterilization


[00841549110627]

Moist Heat or Steam Sterilization


[00841549110627]

Moist Heat or Steam Sterilization


[00841549110627]

Moist Heat or Steam Sterilization


[00841549110627]

Moist Heat or Steam Sterilization


[00841549110627]

Moist Heat or Steam Sterilization


[00841549110627]

Moist Heat or Steam Sterilization


[00841549110627]

Moist Heat or Steam Sterilization


[00841549110627]

Moist Heat or Steam Sterilization


[00841549110627]

Moist Heat or Steam Sterilization


[00841549110627]

Moist Heat or Steam Sterilization


[00841549110627]

Moist Heat or Steam Sterilization


[00841549110627]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-01-10
Device Publish Date2017-05-31

On-Brand Devices [RP Natural Profile Abutment 5.0mm x 3.0mm]

08415491045119The RP Natural Profile Abutment enables the clinician to restore cases that are periodontally an
00841549110627The RP Natural Profile Abutment enables the clinician to restore cases that are periodontally an

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