RP Cover Screw Internal Hex

GUDID 08415491044990

Protects hex head, mating surfaces and internal threads of implants. A cover screw closes off the inside threads of a dental implant during the period of bone healing and implant integration. Healed gingival tissue covers the cover screw and implant.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID08415491044990
NIH Device Record Keya8dd4dc0-9517-4e52-9863-5b590ae2f13b
Commercial Distribution StatusIn Commercial Distribution
Brand NameRP Cover Screw Internal Hex
Version Model Number901016
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
GS108415491044990 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

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 Date2015-11-04

On-Brand Devices [RP Cover Screw Internal Hex]

08415491044990Protects hex head, mating surfaces and internal threads of implants. A cover screw closes off th
00841549106972Protects hex head, mating surfaces and internal threads of implants. A cover screw closes off th

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