RP One-Piece Standard Abutment 5.5mm Cuff

GUDID 08415491043252

RP One-Piece Standard Abutments attach directly to the implant and provide the transitional link between the head of the implant and the restorative components. They are designed to be used for screw retained multi-implant prostheses. Abutments are available in one-piece and two-piece styles. 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 ID08415491043252
NIH Device Record Keyf55e6a8b-7b73-46d4-829e-f49958f81988
Commercial Distribution StatusIn Commercial Distribution
Brand NameRP One-Piece Standard Abutment 5.5mm Cuff
Version Model Number901105
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
GS108415491043252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08415491043252]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2017-05-30

On-Brand Devices [RP One-Piece Standard Abutment 5.5mm Cuff]

08415491043252RP One-Piece Standard Abutments attach directly to the implant and provide the transitional link
00841549107078RP One-Piece Standard Abutments attach directly to the implant and provide the transitional link

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