ERA® Micro DE Female Ti

FDA UDI

Class I (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name: ERA® Micro DE Female Ti FDA UDI
Generic Name: Resilient dental precision attachment FDA UDI
Device Name: Micro ERA distal extension attachment where the female is made of a titanium alloy and is coated using titanium nitride. Designed to be only welded to the end of a titanium bar to retain an overdenture. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant). FDA UDI
Model / Reference: 811607 FDA UDI
Description: Micro ERA distal extension attachment where the female is made of a titanium alloy and is coated using titanium nitride. Designed to be only welded to the end of a titanium bar to retain an overdenture. ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant). FDA UDI

Identifiers

Primary DI / UDI-DI: 00841549102219 FDA UDI
FDA Product Code: EGG FDA UDI
GMDN Term: Resilient dental precision attachment FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3165 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Resilient dental precision attachment

ERA® Micro DE Female Ti by Sterngold Dental LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Sterngold Dental LLC

Sources (1)

FDA UDI f4732913-2f64-4b24-8de9-17a094e50434 34 fields · synced May 31, 2026