ERA® Micro 5° DO Small Post Attachment SS

GUDID 00841549101946

This part contains: 1 female, 2 black, 2 white, and 2 orange males. 1.3mm post diameter, 9mm long. Resilient precision attachment. 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 – 0° (straight), 5°, 11° and 17°, 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 ID	00841549101946
NIH Device Record Key	e28a9194-a643-4145-905a-7e8eead56d5c
Commercial Distribution Status	In Commercial Distribution
Brand Name	ERA® Micro 5° DO Small Post Attachment SS
Version Model Number	811429
Company DUNS	124763728
Company Name	STERNGOLD DENTAL LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com
Phone	401-871-3489
Email	maria.rao@sterngold.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841549101946 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K913348

FDA Product Code

NHA	Abutment, Implant, Dental, Endosseous