ERA Angled 2.2mm Implant Micro 13X4mm, Ti

FDA UDI

Class II (US FDA UDI)

by Sterngold Dental LLC

Identity

Trade Name: ERA Angled 2.2mm Implant Micro 13X4mm, Ti FDA UDI
Generic Name: Dental implant suprastructure, permanent, preformed FDA UDI
Device Name: The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization.This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments.Available in two styles One-Piece, 0° Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23° and 30°. It is made from 6AL-4V ELI Titanium Alloy. The 2.2mm ERA Mini Dental Implants are intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems, such as artificial teeth, in order to restore the patient’s chewing function. FDA UDI
Model / Reference: 901296 FDA UDI
Description: The ERA implant enables the transitional function of a denture during the osseointegration of traditional implants, as well as long term, affordable chairside denture stabilization.This multi-dimensional system comprises the ERA implant, prosthetic components, including the angulation-correction, vertically resilient properties of the ERA Attachments.Available in two styles One-Piece, 0° Micro Head and Two-Piece angle correction. Angle correction available in 0°, 5°, 11°, 17°, 23° and 30°. It is made from 6AL-4V ELI Titanium Alloy. The 2.2mm ERA Mini Dental Implants are intended for long-term as well as temporary surgical implantation in the bone of the patient’s upper or lower arch to provide immediate load or delayed load of prosthetic systems, such as artificial teeth, in order to restore the patient’s chewing function. FDA UDI

Identifiers

Primary DI / UDI-DI: 00841549107207 FDA UDI
510(k) Number: K092434 FDA UDI
FDA Product Code: DZE FDA UDI
GMDN Term: Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3640 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

ERA Angled 2.2mm Implant Micro 13X4mm, Ti by Sterngold Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K092434 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Sterngold Dental LLC

Sources (1)

FDA UDI c57237a1-b04b-4043-a162-9f18d56ca79a 36 fields · synced Jun 1, 2026