Sphero Flex
48 catalogue numbers from SPHERO FLEX ASTRA EV ø 5,4 h.2, listed by Rhein 83 SRL, Italy, under Abutment, Implant, Dental, Endosseous. 15 manufacturers in China are registered for this product code.
15manufacturers in China registered for this device type
48catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (11), Jiangsu (2), Shanghai (1). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Modern Dental Laboratory (DG) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 15 |
| Exceldent Dental Technology Development Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 12 |
| DTS Digital Dental LAB | Shenzhen | Guangdong | Contract manufacturer | 11 |
| KTJ Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Shimmer Computerized Dental Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 10 |
| Zhuhai Crystal Dental Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 9 |
| NEW Perfect Dental LAB | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen Jiahong Dental Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Jiangsu Trausim Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| CBD Dental LAB, Inc | Shenzhen | Guangdong | Manufacturer | 11 |
Showing 12 of 15. All 15 manufacturers in China registered for Abutment, Implant, Dental, Endosseous
Record
| Listed by | Rhein 83 SRL, Italy |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Record published | 2022-07-07 |
| Record revised | 2021-04-19 (version 2) |
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 number | Size | Status |
|---|---|---|
| SPHERO FLEX ASTRA EV ø 5,4 h.2 | In distribution | |
| S/FLEX NOBEL ACTIVE NP ø 3 h.3 TiN | In distribution | |
| SPHERO FLEX REPLACE ø 3,5 h.2 TiN | In distribution | |
| SPHERO FLEX ANKYLOS C/X h.2 | In distribution | |
| SPHERO FLEX EZTETIC ø 3,1 h.7 TiN | In distribution | |
| S/FLEX BONE LEVEL NC ø 3,3 h.3 TiN | In distribution | |
| SPHERO FLEX BRANEMARK ø 3,3 h.1,1 TiN | In distribution | |
| S/ FLEX ENDURE Imtec ø 3,5-4,3 h.2TiN | In distribution | |
| SPHERO FLEX BLX RB-WB h.2 TiN | In distribution | |
| SPHERO FLEX CORE VENT h.6 RIV.TiN | In distribution | |
| SPHERO FLEX STRAUMANN ITI h.1 RIV.TiN | In distribution | |
| SPHERO FLEX STRAUMANN h.2 TiN | In distribution | |
| SPHERO FLEX ASTRA EV ø 3,6 h.4 TiN | In distribution | |
| SPHERO FLEX ASTRA EV ø 5,4 h.4 | In distribution | |
| S/FLEX BIO HORIZONS ø 3 h.3 TiN | In distribution | |
| S/FLEX AB Int/Hex Narrow h.2 TiN | In distribution | |
| SPHERO FLEX ASTRA EV ø 3,6 h.5 TiN | In distribution | |
| S/FLEX ASTRA ST ø 4 h.2 TiN | In distribution | |
| SPHERO FLEX REPLACE SELECT ø 3.5 h.3 TiN | In distribution | |
| SPHERO FLEX ASTRA EV ø 4,2 h.7 | In distribution | |
| S/FLEX BONE LEVEL ø 4,1-4,8 RC h.3 TiN | In distribution | |
| S/FLEX ASTRA ST ø 4 h.7 TiN | In distribution | |
| SPHERO FLEX BONE LEVEL ø4,1-4,8 RC h.4 T | In distribution | |
| SPHERO FLEX ASTRA ACQUA ø 3,5-4 h.1 TiN | In distribution | |
| SPHERO FLEX BONE LEVEL ø4,1-4,8 RC h.1 T | In distribution | |
| SPHERO FLEX REPLACE SELECT ø 3,5 h.4 TiN | In distribution | |
| S/FLEX ASTRA LILLA ø 4,5-5-5S h.3 TiN | In distribution | |
| S/FLEX NOBEL ACTIVE RP ø 4,3/5 h.5 | In distribution | |
| S/FLEX NOBEL ACTIVE NP ø 3,5 h.4 TiN | In distribution | |
| SPHERO FLEX ASTRA EV ø 5,4 h.3 | In distribution | |
| SPHERO FLEX BLX RB-WB h.1 TiN | In distribution | |
| SPHERO FLEX STRAUMANN AT h.2 TiN | In distribution | |
| SPHERO FLEX ANYRIDGE h.3 TiN | In distribution | |
| S/FLEX BONE LEVEL NC ø 3,3 h.6 TiN | In distribution | |
| S/FLEX LEGACY ø 3 h.3 TiN | In distribution | |
| S/FLEX BIO HORIZONS ø 3 h.2 TiN | In distribution | |
| SPHERO FLEX REPLACE SELECT ø 3.5 h.2 TiN | In distribution | |
| SPHERO FLEX STERI OSS ø 3.8 h.5 RIV.TiN | In distribution | |
| SPHERO FLEX STERI OSS E/E ø 3,25 h.3 TiN | In distribution | |
| S/FLEX NOBEL ACTIVE RP ø 4,3/5 h.1 | In distribution | |
| SPHERO FLEX BONE LEVEL ø4,1-4,8 RC h.2 T | In distribution | |
| SPHERO FLEX ASTRA EV ø 3,6 h.2 TiN | In distribution | |
| S/FLEX PRIMA CONNEX ø 4,1 h.5 TiN | In distribution | |
| SPHERO FLEX BRANEMARK ø 3,3 h.1,1 TiN | In distribution | |
| S/FLEX NOBEL ACTIVE RP ø 4,3/5 h.3 | In distribution | |
| S/FLEX BONE LEVEL NC ø 3,3 h.2 TiN | In distribution | |
| S/FLEX BONE LEVEL NC ø 3,3 h.4 TiN | In distribution | |
| SPHERO FLEX ASTRA ACQUA ø 3,5-4 h.2 TiN | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MEDENTiKA | Medentika GmbH | 2,553 |
| LW Vis Abutment | Ossvis Co., Ltd. | 2,520 |
| Dess dental smart solutions | Terrats Medical SL | 1,715 |
| Locator | Zest Anchors, LLC | 1,643 |
| NobelProcera® | Nobel Biocare AB | 1,526 |
| Azure | Terrats Medical SL | 1,360 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 1,308 |
| LW Vis Abutment SET | Ossvis Co., Ltd. | 1,260 |
| Abutment, Implant, Dental, Endosseous | Southern Implants (PTY) Ltd | 1,240 |
| Healing Abutment | Megagen Implant Co., Ltd. | 1,218 |
| Chaorum Implant System | Medimecca Co Ltd | 1,084 |
| OT Equator | Rhein 83 SRL | 1,051 |
Showing 12 of 6,204. All products under Abutment, Implant, Dental, Endosseous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K171409 | 2018-04-09 |
| K160382 | 2016-08-11 |
| K142211 | 2015-11-25 |
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.