ERA® DO SP Master Kit W/ Tools SS

This part contains: Five small post females, (2- 0° , 1 each 5°, 11°, and 17°), Males, 5 sets of 5, (two each of white and black and one orange), 2 metal jackets, 2 Processing jigs, 2…

Registry build 21.09.26

This part contains: Five small post females, (2- 0° , 1 each 5°, 11°, and 17°), Males, 5 sets of 5, (two each of white and black and one orange), 2 metal jackets, 2 Processing jigs, 2 alignment handles, 1 of each Gutta percha drill, pilot drill, countersink bur, core cutter bur and seating tool. 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. 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.

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® DO SP Master Kit w/ Tools SS
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 2020-07-07
Record revised 2025-08-01 (version 3)

Specifications

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

Catalogue Numbers

Catalogue numbers for ERA® DO SP Master Kit w/ Tools SS
Catalogue number Size Status
811400 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer