Sphero Block Normo
DISPOSABLE device in plastic material to be embodied in a removable prosthesis.
6manufacturers in China registered for this device type
1catalogue number
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 | Rhein 83 SRL, Italy |
|---|---|
| FDA product code | EGG |
| Device type | Attachment, Precision, All |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3165 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-07-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Liquid Chemical |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| YELLOW OT EQUATOR CAP 500 u. | In distribution |
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.