ERA® Direct Overdenture Mixed Kit SS
This part contains: Small diameter post females, 2-0° plus one each 5°, 11°, and 17°, Large diameter post females, 2-0° plus one each 5°, 11°, and 17°, Males, 10 sets of 5 - 2 ea of white,…
This part contains: Small diameter post females, 2-0° plus one each 5°, 11°, and 17°, Large diameter post females, 2-0° plus one each 5°, 11°, and 17°, Males, 10 sets of 5 – 2 ea of white, black and 1 orange, 2 metal jackets, 2 sets of 4, Processing jigs, 4, Alignment handles, 4, Pilot drills, 2 blockout spacers, 1 small diameter and 1 large diameter, Countersink burs, 1 small diameter and 1 large diameter, Gutta percha drill, 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 | 2023-12-05 (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, expiry date, manufacturing date |
| Distribution end date | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 811398 | 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.