Who else makes this device?

Name: ERA® Standard Overdenture Attachment
Brand: ERA® Standard Overdenture Attachment

Dental › ProstheticAttachment, Precision, All

ERA® Standard Overdenture Attachment

Resilient semi-precision attachment. Contents: 1 female and 2-Black males 2-white males, and 1 orange male. Attachments are two-part connectors. One part is intraorally fixed as part of a…

Registry build 21.09.26

Resilient semi-precision attachment. Contents: 1 female and 2-Black males 2-white males, and 1 orange male. Attachments are two-part connectors. One part is intraorally fixed as part of a fixed (i.e. not patient removable) dental restoration, and a replaceable, high density nylon male anchored into a patient removable dental prosthesis (denture base). When the removable prosthesis is seated in the mouth the attachment parts come together and secure it in place. In other applications the attachment connects two sections of a segmented fixed partial denture.

6manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Guangdong (2), Hong Kong (2), Hubei (1).

Chinese manufacturers registered for FDA product code EGG
Manufacturer	City	Province	Registered as	Device types
Shenzhen Sunmc Dental Technology Co., Ltd.	Shenzhen	Guangdong	Manufacturer	17
Qibei Technology Co., Limited	Kl	Hong Kong	Manufacturer	15
Hubei YJT Intelligent Technology Group Co., Ltd.	Wuhan	Hubei	Contract manufacturer	12
Crown Trading (HK) Co., Limited	Hong Kong	Hong Kong	Manufacturer	8
Vivi Dental Laboratory	Shenzhen	Guangdong	Manufacturer	8
Shanghai Shift Electrics Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	7

Record

Regulatory record for ERA® Standard Overdenture Attachment
Listed by	Sterngold Dental LLC, United States
FDA product code	EGG
Device type	Attachment, Precision, All
Device class	Class 1
Regulation	21 CFR 872.3165
Establishment	Repacker / relabeller, Manufacturer
510(k)	K913348
Record published	2017-02-22
Record revised	2025-08-29 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for ERA® Standard Overdenture Attachment
Catalogue number	Size	Status
811310		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Ceka & Preci-Line Attachments	Alphadent Co., Ltd.	300
Dental Attachments	Rhein 83 SRL	202
Preat	Preat Corporation	192
SI	Shinhung MST Co., Ltd.	140
Dental Equipments	Rhein 83 SRL	83
OT Equator – OT Bridge	Rhein 83 SRL	82
evertis	Shinhung MST Co., Ltd.	71
StecoTitanmagnetics®	Steco-System-Technik Gmbh & Co. KG	70
Implant Prosthetics	Preat Corporation	70
‘MagnaCap’ Magnetic Retention System	Technovent Limited	61
Zaag	Zest Anchors, LLC	48
Locator®	Zest Anchors, LLC	47

Showing 12 of 333. All products under Attachment, Precision, All

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.