ERA® Micro 5° DO Small Post Female SS

GUDID 08415491134363

This part contains: 1 female 1.3mm post diameter, 9mm long. These attachments are placed in the retained tooth root, which has been prepared to receive the fixed attachment component. The other component of the attachment becomes part of a patient removable overdenture, which is a denture partially supported by one or more retained roots. ERA Direct Placement Overdenture is available in standard and micro sizes. This product consist of a stainless steel female with a titanium nitride coating and a choice of four different post angles – 0º (straight), 5º, 11º and 17º, and two post diameters – 1.3mm and 1.7mm, both 9mm long. Six color coded males to create a consistent level of retention (white, orange, blue, grey, yellow, red). An optional metal jacket is also available to hold the attachment male in the denture base and is sold pre-loaded with a black fabrication male. Intended to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function.

STERNGOLD DENTAL LLC

Dental implant suprastructure, permanent, preformed
Primary Device ID08415491134363
NIH Device Record Keyc6452f75-966d-4aa1-99b6-d2a09ad08b1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameERA® Micro 5° DO Small Post Female SS
Version Model Number811427
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
GS108415491134363 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08415491134363]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2017-06-07

On-Brand Devices [ERA® Micro 5° DO Small Post Female SS]

08415491134363This part contains: 1 female 1.3mm post diameter, 9mm long. These attachments are placed in the
00841549101939This part contains: 1 female 1.3mm post diameter, 9mm long. These attachments are placed in the

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