ERA® DO LP Master Kit W/ Tools SS
This part contains:Five Large 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…
This part contains:Five Large 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, 2 blockout spacers, 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.
Who Else Makes It
Concentrated in Guangdong (2), Hong Kong (2), Hubei (1).
| 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
| 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 |
| Record published | 2020-07-07 |
| Record revised | 2024-03-13 (version 2) |
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 |
| Distribution end date | 2024-03-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 811402 | Withdrawn |
Same 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.