Sphero Block Micro
202 catalogue numbers from SET S.BLOCK M. ASTRA EV ø 4.8 h5, listed by Rhein 83 SRL, Italy, under Implant, Endosseous, Root-Form. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
202catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (3), Sichuan (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Jiangsu Trausim Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Basic (Chengdu) Medical Device Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 1 |
| Dongguan Xinlonghong Hardware Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 1 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| BIO Concept Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | Rhein 83 SRL, Italy |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Record published | 2025-07-03 |
| Record revised | 2020-12-18 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2021-04-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SET S.BLOCK M. ASTRA EV ø 4.8 h5 | In distribution | |
| S/BLOCK M ASTRA EV ø 3 h.5 TiN | In distribution | |
| SET S.BLOCK M. ASTRA STD ø 4 NC h3 | In distribution | |
| SET S.BLOCK M. ASTRA STD ø 4 NC h1 | In distribution | |
| S/B/M BONE LEVEL RC ø 4,1/4,8 h 5 TiN | In distribution | |
| SET S.BLOCK M. ASTRA ACQUA ø 3.5-4 h5 | In distribution | |
| SPHERO BLOCK M/BIO HORIZONS ø 4 h.4 TiN | In distribution | |
| SET S.BLOCK M. REPLACESELECT ø 3.5 h2 | In distribution | |
| SET S.BLOCK M. ASTRA EV ø 4.8 h3 | In distribution | |
| SPHERO BLOCK M/BIO HORIZONS ø 4 h.7 TiN | In distribution | |
| SPHERO BLOCK M/BIO HORIZONS ø 4 h.5 TiN | In distribution | |
| SET S.BLOCK M. BIOHORIZONS ø 5 h2 | In distribution | |
| SET S.BLOCK M. PREMIUM KOHNO ø 3.8 h2 | In distribution | |
| SET S.BLOCK M. CONELOG ø 3.3 h1 | In distribution | |
| S/BLOCK M BIO HORIZONS ø 3 h.6 TiN | In distribution | |
| SPHERO BLOCK M/BIO HORIZONS ø 5 h.3 TiN | In distribution | |
| SET S.BLOCK M. BLX RB-WB h2 | In distribution | |
| S/BLOCK MICRO SUSTAIN E/E ø 3.4 h.2 TiN | In distribution | |
| SPHERO BLOCK M/BIO HORIZONS ø 4 h.6 TiN | In distribution | |
| SET S.BLOCK M. REPLACESELECT ø 3.5 h4 | In distribution | |
| S/BLOCK M BIO HORIZONS ø 3,5 h.7 TiN | In distribution | |
| SPHERO BLOCK M. BLX RB-WB h.6 TiN c/tas | In distribution | |
| S/BLOCK MICRO LEGACY ø 3 h.3 TiN | In distribution | |
| S/BLOCK MICRO ANKYLOS C/X h.5 TiN | In distribution | |
| SPHERO BLOCK MICRO LASER-LOK ø 3 h.1 TiN | In distribution | |
| SET S.BLOCK M. NEODENT GM h4 | In distribution | |
| SET S.BLOCK M. PREMIUM KOHNO ø 3.8 h1 | In distribution | |
| S/BLOCK M. BONE LEVEL SC ø 2,9 h.4 TiN | In distribution | |
| SPHERO BLOCK M BICON ø 3-3,5 h.6 TiN | In distribution | |
| S/BLOCK M ENDURE IMTEC ø 4,3 h.3 TiN | In distribution | |
| S/B/MICRO STRAUMANN ITI WN ø 6,5 h.3 TiN | In distribution | |
| SET S.BLOCK M. INDEX STD WIDE h05 | In distribution | |
| SET S.BLOCK M. CERTAIN 3I ø 3.25 h6 | In distribution | |
| S/BLOCK M ASTRA EV ø 3,6 h.1,1 | In distribution | |
| SET S.BLOCK M. ASTRA LILLA ø4.5-5-5S h2 | In distribution | |
| S. BLOCK MICRO/BIO HORIZONS ø 5 h.4 TiN | In distribution | |
| SPHERO BLOCK M ANYRIDGE h.1 TiN | In distribution | |
| SET S.BLOCK M. PRIMACONNEX ø 4.1 h5 | In distribution | |
| S/BLOCK M NOBEL ACTIVE RP ø 4,3/5 h4 TiN | Withdrawn | |
| S/BLOCK MICRO ANKYLOS C/X h.1 TiN | Withdrawn | |
| S/BLOCK MICRO CAMLOG ø 3,3 h.2 TiN | Withdrawn | |
| S/BLOCK M ASTRA EV ø 3,6 h.6 | Withdrawn | |
| S/BLOCK M ASTRA EV ø 3,6 h.4 | Withdrawn | |
| S/BLOCK M NOBEL ACTIVE RP ø 4,3/5 h3 TiN | Withdrawn | |
| S/BLOCK M BIO HORIZONS ø 3,5 h.3 TiN | Withdrawn | |
| S/B/MICRO STRAUMANN ITI WN ø 6,5 h.1 TiN | Withdrawn | |
| S/B/M BONE LEVEL RC ø 4,1/4,8 h 3 TiN | Withdrawn | |
| S/BLOCK M x GP NARROW SAFE ø 2,9 h.1 TiN | Withdrawn | |
| S/BLOCK M NOBEL ACTIVE NP ø 3 h.5 TiN | Withdrawn | |
| SPHERO BLOCK MICRO STERI OSS ø 3,8 h2TiN | Withdrawn | |
| S/BLOCK M ASTRA LILLA ø4,5-5-5S h.3 TiN | Withdrawn | |
| SPHERO BLOCK M/SPLINE ø 3.25 h.2 TiN | Withdrawn | |
| SPHERO BLOCK M ANYRIDGE h.3 TiN | Withdrawn | |
| S/BLOCK M ASTRA ACQUA ø 3,5-4 h.4 TiN | Withdrawn | |
| S/BLOCK MICRO SCREW VENT ø 5,7 h.7 TiN | Withdrawn | |
| S/BLOCK MICRO STRAUMANN ITI h.0,5 TiN | Withdrawn | |
| SPHERO BLOCK MICRO SteriOss ø3.25 h3 TiN | Withdrawn | |
| SPHERO BLOCK Micro CORE VENT h.3 RIV.TiN | Withdrawn | |
| SPHERO B/MICRO INTEGRAL ø 4 h.4 TiN | Withdrawn | |
| S/BLOCK MICRO S.P.I. ø 6 h. 4 TiN | Withdrawn | |
| SPHERO BLOCK MICRO S.P.I. ø 3,5 h.3TiN | Withdrawn | |
| SPHERO BLOCK MICRO CAMLOG ø 5 h.4 TiN | Withdrawn | |
| SPHERO BLOCK MICRO SPLINE ø 5 h.2 TiN | Withdrawn | |
| SPHERO BLOCK MICRO ASTRA EV ø 3 h.6 Tin | Withdrawn | |
| S/BLOCK MICRO N/NECK Crossfit h.1 TiN | Withdrawn | |
| S/B MICRO PRIMA CONNEX ø 3,5 h.3 TiN | Withdrawn | |
| SPHERO BLOCK M ANYRIDGE h.4 TiN | Withdrawn | |
| S/BLOCK M NOBEL ACTIVE NP ø 3,5 h.6 TiN | Withdrawn | |
| S/BLOCK MICRO CERTAIN 3I ø4,1 h.2 TiN | Withdrawn | |
| S/BLOCK MICRO CERTAIN 3I ø 6 h.1 TiN | Withdrawn | |
| S/BLOCK M ASTRA EV ø 3,6 h.2 | Withdrawn | |
| S/BLOCK M BIO HORIZONS ø 3 h.1 TiN | Withdrawn | |
| S/BLOCK M ASTRA EV ø 3,6 h.3 | Withdrawn | |
| S/BLOCK M NOBEL ACTIVE NP ø 3,5 h.1 TiN | Withdrawn | |
| S/BLOCK MICRO CERTAIN 3I ø4,1 h.3 TiN | Withdrawn | |
| S/BLOCK M PRIMA CONNEX ø 4,1 h.1 TiN | Withdrawn | |
| S/B/MICRO BONE LEVEL NC ø 3,3 h.2 TiN | Withdrawn | |
| S/BLOCK M BIO HORIZONS ø 3 h.2 TiN | Withdrawn | |
| SPHERO B/MICRO BIO VENT ø 4.5 h.4 TiN | Withdrawn | |
| S/BLOCK M ENDOPORE E/Int.ø 5 h.4 TiN | Withdrawn | |
| S/BLOCK MICRO CERTAIN 3I ø 4,1 h.5 TiN | Withdrawn | |
| S/BLOCK M ASTRA ACQUA ø 3,5-4 h.2 TiN | Withdrawn | |
| SPHERO B/MICRO BIO VENT ø 4,5 h.3 TiN | Withdrawn | |
| SPHERO BLOCK MICRO ASTRA EV ø 3 h.1 Tin | Withdrawn | |
| S/BLOCK MICRO ASTRA ø 3 h.5 TiN | Withdrawn | |
| SPHERO B/M ReplaceSelect ø4.3 h0,5 TIN | Withdrawn | |
| S/BLOCK M ASTRA LILLA ø 4,5-5-5S h.1 TiN | Withdrawn | |
| S/BLOCK MICRO ASTRA ø 3 h.2 TiN | Withdrawn | |
| SPHERO BLOCK MICRO ASTRA EV ø 3 h.4 Tin | Withdrawn | |
| S/BLOCK MICRO STERI OSS ø 3,8 h.3 TiN | Withdrawn | |
| S/BLOCK M NOBEL ACTIVE ø 3 h.1 TiN | Withdrawn | |
| S/BLOCK MICRO ASTRA ø 3 h.1 TiN | Withdrawn | |
| S/BLOCK MICRO CAMLOG ø 4,3 h.5 TiN | Withdrawn | |
| SPHERO BLOCK M/SPLINE ø 3,25 h.5 TiN | Withdrawn | |
| S/B/MICRO BONE LEVEL NC ø 3,3 h.6 TiN | Withdrawn | |
| S/BLOCK M INTRA LOCK E/E ø 3,3 h.1 TiN | Withdrawn | |
| S/BLOCK M PRIMA CONNEX ø 4,1 h.3 TiN | Withdrawn | |
| SPHERO B/MICRO INTEGRAL ø 4 h.3 TiN | Withdrawn | |
| SPHERO B/MICRO BIO VENT ø 4,5 h.2 TiN | Withdrawn | |
| S/BLOCK MICRO CERTAIN 3I ø 5 h.2 TiN | Withdrawn | |
| S/B/MICRO BONE LEVEL NC ø 3,3 h.4 TiN | Withdrawn | |
| S/BLOCK Micro REPLACE 3.5 h.5 TiN | Withdrawn | |
| S/BLOCK M ASTRA ACQUA ø 3,5-4 h.3 TiN | Withdrawn | |
| S/BLOCK MICRO CERTAIN 3I ø4,1 h.1 TiN | Withdrawn | |
| S/BLOCK M NOBEL ACTIVE NP ø 3,5 h.4 TiN | Withdrawn | |
| S/BLOCK MICRO LEGACY ø 3 h.1 TiN | Withdrawn | |
| SPHERO BLOCK M/SPLINE ø 3,25 h.3 TiN | Withdrawn | |
| S/BLOCK MICRO CERTAIN 3I ø 3,25 h.3 TiN | Withdrawn | |
| SPHERO BLOCK Micro BRANEMARK h.3 RIV.TiN | Withdrawn | |
| SPHERO BLOCK MICRO STRAUMANN ITI h.2 TiN | Withdrawn | |
| S/BLOCK MICRO STERI OSS ø 3.25 h.0,5 TiN | Withdrawn | |
| S/ BLOCK M MINI MN ø 3-3,25 h.4 TiN | Withdrawn | |
| S/BLOCK MICRO ASTRA ø 3 h.4 TiN | Withdrawn | |
| S/BLOCK MICRO ANKYLOS C/X h.6 TiN | Withdrawn | |
| SPHERO BLOCK MICRO S.P.I. ø 3,5 h.2TiN | Withdrawn | |
| SPHERO BLOCK Micro BRANEMARK h.1,3 TiN | Withdrawn | |
| SPHERO BLOCK MICRO STRAUMANN ITI h.3 TiN | Withdrawn | |
| S/BLOCK M ASTRA ACQUA ø 3,5-4 h.6 TiN | Withdrawn | |
| S/BLOCK MICRO INTEGRAL ø 4 h.1 TiN | Withdrawn | |
| S/BLOCK M NOBEL ACTIVE RP ø 4,3/5 h1 TiN | Withdrawn | |
| S/BLOCK M BIO HORIZONS ø 3,5 h.5 TiN | Withdrawn | |
| S/BLOCK M BIO HORIZONS ø 3,5 h.2 TiN | Withdrawn | |
| S/BLOCK MICRO CAMLOG ø 4,3 h.6 TiN | Withdrawn | |
| S/BLOCK MICRO LEGACY ø 3 h.4 TiN | Withdrawn | |
| SPHERO BLOCK M ANYRIDGE h.5 TiN | Withdrawn | |
| S/BLOCK M BIO HORIZONS ø 3 h.5 TiN | Withdrawn | |
| S/B/M BONE LEVEL RC ø 4,1/4,8 h 1 TiN | Withdrawn | |
| S/BLOCK MICRO CERTAIN 3I ø 5 h.1 TiN | Withdrawn | |
| SPHERO BLOCK MICRO Steri Oss 3.25 h2 TiN | Withdrawn | |
| S/BLOCK MICRO S.P.I. ø 6 h. 3 TiN | Withdrawn | |
| SPHERO BLOCK MICRO ANALOG KIT | Withdrawn | |
| SPHERO BLOCK MICRO STRAUMANN ITI h.1 TiN | Withdrawn | |
| S/ BLOCK M MINI MN ø 3-3,25 h.2 TiN | Withdrawn | |
| S/BLOCK M BIO HORIZONS ø 3 h.4TiN | Withdrawn | |
| S.BLOCK M ENDURE Imtec ø4,3 h.1TiN | Withdrawn | |
| S/ BLOCK M MINI MN ø 3-3,25 h.3 TiN | Withdrawn | |
| S/BLOCK MICRO CERTAIN 3I ø 5 h.3 TiN | Withdrawn | |
| SPHERO BLOCK M/BIO HORIZONS ø 4 h.3 TiN | Withdrawn | |
| S/B/MICRO BONE LEVEL NC ø 3,3 h.1 TiN | Withdrawn | |
| S/BLOCK MICRO CERTAIN 3I ø 5 h.5 TiN | Withdrawn | |
| S/BLOCK MICRO CERTAIN 3I ø 3,25 h.2 TiN | Withdrawn | |
| S/BLOCK M PRIMA CONNEX ø 4,1 h.4 TiN | Withdrawn | |
| S/B/MICRO BONE LEVEL NC ø 3,3 h.5 TiN | Withdrawn | |
| SPHERO BLOCK Micro REPLACE ø.5 h.2 TiN | Withdrawn | |
| S/BLOCK M ASTRA EV ø 4,2 h.4 TIN | Withdrawn | |
| S/BLOCK M BIO HORIZONS ø 3 h.3 TiN | Withdrawn | |
| S/BLOCK Micro STERI OSS ø 3,25 h.2 TiN | Withdrawn | |
| S/BLOCK MICRO ReplaceSelect ø3,5 h.1 TiN | Withdrawn | |
| SPHERO BLOCK MICRO STRAUMANN TiN | Withdrawn | |
| SPHERO B/MICRO BIO VENT ø 4,5 h.1 TiN | Withdrawn | |
| SPHERO BLOCK MICRO ASTRA EV ø 3 h.2 Tin | Withdrawn | |
| S/BLOCK M ASTRA EV ø 4,2 h.5 TIN | Withdrawn | |
| S/BLOCK M ASTRA EV ø 4,2 h.3 | Withdrawn | |
| S/BLOCK M BIO HORIZONS ø 3,5 h.6 TiN | Withdrawn | |
| S/BLOCK M. CERTAIN 3I ø 3,25/3,4 h.1 TiN | Withdrawn | |
| S/BLOCK MICRO CERTAIN 3I ø 4,1 h.6 TiN | Withdrawn | |
| S/BLOCK MICRO CERTAIN 3I ø 3,25 h.3 TiN | Withdrawn | |
| S/BLOCK MICRO SPLINE ø 3,75-4 h.3 TiN | Withdrawn | |
| S/BLOCK MICRO LEGACY ø 3 h.0.5 TiN | Withdrawn | |
| SPHERO BLOCK Micro CORE VENT h.0.5 TiN | Withdrawn | |
| S/BLOCK M BIO HORIZONS ø 4 h.1,5 TiN | Withdrawn | |
| S/BLOCK M NOBEL ACTIVE NP ø 3,5 h.5 TiN | Withdrawn | |
| S/BLOCK MICRO ReplaceSelect ø4.3 h.1 TiN | Withdrawn | |
| S/BLOCK M ASTRA EV ø 4,2 h.2 | Withdrawn | |
| SPHERO BLOCK Micro CORE VENT h.5 RIV.TiN | Withdrawn | |
| SPHERO BLOCK Micro CORE VENT h.1 RIV.TiN | Withdrawn | |
| S/BLOCK M NOBEL ACTIVE NP ø 3,5 h.3 TiN | Withdrawn | |
| S/BLOCK MICRO ASTRA ø 3 h.0,5 TiN | Withdrawn | |
| S/BLOCK M NOBEL ACTIVE NP ø 3,5 h.2 TiN | Withdrawn | |
| SPHERO BLOCK Micro CORE VENT h.2 RIV.TiN | Withdrawn | |
| SPHERO B/MICRO BIO VENT ø 4,5 h.0,5 TiN | Withdrawn | |
| S/BLOCK M MIS – SEVEN ø 3,75-4,2 h.2 TiN | Withdrawn | |
| S/BLOCK M NOBEL ACTIVE RP ø 4,3/5 h6 TiN | Withdrawn | |
| S/B MICRO PRIMA CONNEX ø 3,5 h.4 TiN | Withdrawn | |
| SPHERO BLOCK M ASTRA EV ø 4,8 h.2 | Withdrawn | |
| S/BLOCK MICRO ANKYLOS C/X h.3 TiN | Withdrawn | |
| S/BLOCK MICRO CERTAIN 3I ø 3,25 h.4 TiN | Withdrawn | |
| S/BLOCK M NOBEL ACTIVE NP ø 3 h.3 TiN | Withdrawn | |
| S/BLOCK MICRO ReplaceSelect ø4.3 h.3 TiN | Withdrawn | |
| S/BLOCK M NOBEL ACTIVE RP ø 4,3/5 h2 TiN | Withdrawn | |
| SPHERO BLOCK M ANYRIDGE h.2 TiN | Withdrawn | |
| SPHERO BLOCK M/BIO HORIZONS ø 4 h.2 TiN | Withdrawn | |
| S/BLOCK M NOBEL ACTIVE RP ø 4,3/5 h5 TiN | Withdrawn | |
| SPHERO BLOCK Micro CORE VENT h.4 RIV.TiN | Withdrawn | |
| S/BLOCK MICRO ReplaceSelect ø4.3 h.2 TiN | Withdrawn | |
| S/BLOCK MICRO LEGACY ø 3 h.2 TiN | Withdrawn | |
| S/BLOCK MICRO CERTAIN 3I ø4,1 h.4TiN | Withdrawn | |
| S/BLOCK M ASTRA EV ø 3,6 h.5 | Withdrawn | |
| S/BLOCK MICRO CERTAIN 3I ø 5 h.4 TiN | Withdrawn | |
| S/BLOCK MICRO CERTAIN 3I ø 3,25 h.5 TiN | Withdrawn | |
| S/BLOCK MICRO ANKYLOS C/X h.2 TiN | Withdrawn | |
| S/BLOCK MICRO BRK/Restore WP ø 5 h.2 TiN | Withdrawn | |
| S/BLOCK M BIO HORIZONS ø 3 h.7 TiN | Withdrawn | |
| SPHERO BLOCK Micro REPLACE ø 4,3 h.2 TiN | Withdrawn | |
| S/BLOCK MICRO LEGACY ø 3 h.3 TiN | Withdrawn | |
| S/B/MICRO BONE LEVEL NC ø 3,3 h.3 TiN | Withdrawn | |
| S/B/M BONE LEVEL RC ø 4,1/4,8 h 4 TiN | Withdrawn | |
| S/BLOCK MICRO ASTRA ø 3 h.3TiN | Withdrawn | |
| SPHERO BLOCK MICRO ASTRA EV ø 3 h.3 Tin | Withdrawn | |
| SPHERO BLOCK MICRO ANKYLOS s/bdg TiN | Withdrawn | |
| S/BLOCK M ASTRA EV ø 5,4 h.4 | Withdrawn | |
| S/BLOCK M BIO HORIZONS ø 3,5 h.4 TiN | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 920 |
| Osstem Implant System | Osstem Implant Co., Ltd. | 788 |
| Magicore | InnoBioSurg Co., Ltd.(IBS implant Co., Ltd.) | 744 |
| Implant, Endosseous, Root-Form | Southern Implants (PTY) Ltd | 608 |
| ITL Dental | Emery Enterprises Inc. | 603 |
| Magicore S | InnoBioSurg Co., Ltd.(IBS implant Co., Ltd.) | 560 |
| Friadent® | Dentsply Implants Manufacturing GmbH | 525 |
| Sphero Block Normo | Rhein 83 SRL | 489 |
| Neobiotech Implant System | Neobiotech Co., Ltd. | 483 |
| KJ Mini Implant System | Kjmeditech.co., Ltd. | 448 |
| Ritter Dental Implant System | Ritter Implants GmbH & Co. KG | 418 |
| Leone SPA | Leone SPA | 404 |
Showing 12 of 2,762. All products under Implant, Endosseous, Root-Form
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K033630 | 2004-04-21 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P800035 | 2001-10-04 | PERI-OSS | Curasan AG |
| P860012 | 1988-10-28 | ALVEOFORM TM BIOGRAFT | Collagen Corp. |
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.