Sphero Block Normo
108 catalogue numbers from S/BLOCK N STRAUMANN ITI WN H 0.5 TiN, 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
108catalogue 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 |
| Premarket notification | Exempt |
| Record published | 2021-07-23 |
| Record revised | 2021-04-19 (version 3) |
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, expiry date, manufacturing date, serial number |
| Distribution end date | 2021-04-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S/BLOCK N STRAUMANN ITI WN H 0.5 TiN | In distribution | |
| SPHERO B/NORMO INDEX ø 3,4 h.4 TiN | In distribution | |
| S/BLOCK NORMO FRIALIT 2 ø 3,8 h.1 TiN | In distribution | |
| S/BLOCK N NOBEL ACTIVE ø 3 h.4 TiN | In distribution | |
| S/BLOCK INDEX Std e Wide h.5 TiN | In distribution | |
| S/BLOCK N BONE LEVEL RC ø4,1-4,8 h.7 TiN | In distribution | |
| S/BLOCK NORMO SUSTAIN ø 3,3 h.7 TiN | In distribution | |
| SPHERO BLOCK N ASTRA EV ø 4,2 h.2 | In distribution | |
| S/BLOCK NORMO BIO VENT ø 4,5 h.3 TiN | In distribution | |
| SPHERO BLOCK NORMO ASTRA EV ø 3,6 h.3 | In distribution | |
| S/BLOCK N ASTRA ST ø 4 h.2 TiN | In distribution | |
| SPHERO BLOCK NORMO ASTRA EV ø 3,6 h.2 | In distribution | |
| SPHERO BLOCK NORMO ASTRA EV ø 3 h.1 Tin | In distribution | |
| S/BLOCK NORMO RESTORE E/E SD h.3 TiN | In distribution | |
| SPHERO BLOCK N SCREW VENT h.6 TiN | In distribution | |
| S.BLOCK NORMO SARGON IMPLANT d.3.8 h.2 | In distribution | |
| S/BLOCK NORMO ASTRA ø 3 h.5 TiN | In distribution | |
| S/BLOCK NORMO INTEGRAL ø 4 h.1 TiN | In distribution | |
| SPHERO B/NORMO INDEX ø 3,4 h.2 TiN | In distribution | |
| S/BLOCK NORMO Tri Nex ø 3,5 h.4 TiN | In distribution | |
| S/ BLOCK NORMO REPL/SELECT ø 3,5 h.4 TiN | In distribution | |
| S/BLOCK NORMO CERTAIN 3I ø 4,1 h.2 TiN | In distribution | |
| S/BLOCK NORMO IP Piccolo H/E ø 3 h.4 TiN | In distribution | |
| SPHERO BLOCK ANYRIDGE h.4 TiN | In distribution | |
| S/BLOCK N PRIMA CONNEX ø 3,5 h.2 TiN | In distribution | |
| S/ BLOCK NORMO NOBEL ACTIVE WP h.3 | In distribution | |
| S/B/NORMO BONE LEVEL NC ø 3,3 h.1 TiN | In distribution | |
| S/ BLOCK NORMO REPL/SELECT ø 3,5 h.2 TiN | In distribution | |
| S/ BLOCK NORMO REPL/SELECT ø 5 h.1 TiN | In distribution | |
| SPHERO BLOCK NORMO ASTRA EV ø 3 h.2 Tin | In distribution | |
| S/BLOCK N BONE LEVEL RC ø4,1-4,8 h.6 TiN | In distribution | |
| SPHERO BLOCK N/BIO HORIZONS ø 4 h.4 TiN | In distribution | |
| S/BLOCK NORMO INTEGRAL ø 4 h.3 TiN | In distribution | |
| S/BLOCK NORMO BRANEMARK ø 3,3 h.4 TiN | In distribution | |
| S/BLOCK NORMO SCREW VENT ø 5,7 h.5 TiN | In distribution | |
| SPHERO BLOCK NORMO ASTRA EV ø 3 h.3 Tin | In distribution | |
| SPHERO BLOCK ASTRA EV ø 5,4 h.1 TIN | In distribution | |
| S/BLOCK NORMO SUSTAIN ø 3,3 h.3 TiN | In distribution | |
| S/BLOCK NORMO FRIALIT 2 ø 3,8 h.2 TiN | In distribution | |
| S/BLOCK NORMO CERTAIN 3I ø 5 h.6 TiN | In distribution | |
| SPHERO BLOCK MICRO ASTRA EV ø 3 h.1 Tin | In distribution | |
| SPHERO BLOCK ASTRA EV ø 5,4 h.2 TIN | In distribution | |
| S/BLOCK N PRIMA CONNEX ø 3,5 h.3 TiN | In distribution | |
| SPHERO BLOCK N ASTRA EV ø 4,2 h.4 | In distribution | |
| S/BLOCK NOBEL ACTIVE RP ø 4,3/5 h.6 TiN | In distribution | |
| SPHERO BLOCK ANKYLOS C/X h.3 | In distribution | |
| S/ BLOCK NORMO REPL/SELECT ø 4,3 h.4 TiN | In distribution | |
| S/ B/NORMO ENDURE Imtec ø 3,5-4,3 h.3TiN | In distribution | |
| S/BLOCK NORMO NEODENT FACILITY h.2 TiN | In distribution | |
| S/BLOCK N NOBEL ACTIVE ø 3 h.7 TiN | In distribution | |
| S/BLOCK N BIO HORIZONS ø 3 h.5 TiN | In distribution | |
| S/ BLOCK N MINI MN ø 3-3,25 h.4 TiN | In distribution | |
| S/BLOCK N NOBEL ACTIVE ø 3 h.5 TiN | In distribution | |
| S/BLOCK NORMO INTEGRAL ø 4 h.0,5 TiN | In distribution | |
| S/ BLOCK NORMO Tri-Nex ø 5 h.2 TiN | In distribution | |
| S/BLOCK N ASTRA LILLA ø 4,5-5 h.3 TiN | In distribution | |
| S/ BLOCK NORMO REPL/SELECT ø 4,3 h.3 TiN | In distribution | |
| SPHERO BLOCK ANKYLOS C/X h.7 | In distribution | |
| SPHERO BLOCK ANKYLOS C/X h.5 | In distribution | |
| S/BLOCK NOBEL ACTIVE RP ø 4,3/5 h.3 TiN | In distribution | |
| SPHERO BLOCK N ASTRA EV ø 4,2 h.1 | In distribution | |
| S/BLOCK NORMO CERTAIN 3I ø 3,25 h.5 TiN | In distribution | |
| S/BLOCK NORMO LEGACY ø 3 h.6 TiN | In distribution | |
| S/BLOCK NORMO CERTAIN 3I ø 4,1 h.5 TiN | In distribution | |
| S/ BLOCK NORMO REPL/SELECT ø 4,3 h.1 TiN | In distribution | |
| SPHERO BLOCK ASTRA EV ø 5,4 h.3 TIN | In distribution | |
| SPHERO BLOCK ANYRIDGE h.6 TiN | In distribution | |
| S/BLOCK NORMO ASTRA ø 3 h.0,7 TiN | In distribution | |
| S/BLOCK NORMO BRANEMARK NP ø 3,3 h.3 TiN | In distribution | |
| S/B MICRO PRIMA CONNEX ø 3,5 h.4 TiN | In distribution | |
| SPHERO BLOCK N h.0,5 (da Vs. campione) | In distribution | |
| S/BLOCK NORMO REPLACE ø 4,3 h.2 TiN | In distribution | |
| S/BLOCK NORMO SPLINE ø 3,75-4 h.1,6 TiN | In distribution | |
| S/ BLOCK NORMO REPL/SELECT ø 3,5 h.3 TiN | In distribution | |
| S/BLOCK N NOBEL ACTIVE NP ø 3,5 h.5 TiN | In distribution | |
| S/B/NORMO BONE LEVEL NC ø 3,3 h.7 TiN | In distribution | |
| S/BLOCK N STERI OSS ø 3,25 h.3 TiN | In distribution | |
| S/BLOCK NORMO INTEG/OMNIL. ø 3,25 h.4TiN | In distribution | |
| SPHERO BLOCK NORMO EZTETIC ø 3,1 h.3 | In distribution | |
| S/BLOCK NORMO CERTAIN 3I ø 4,1 h. 6 TiN | In distribution | |
| S/BLOCK N BONE LEVEL SC ø 2,9 h.2 TiN | In distribution | |
| S/ BLOCK NORMO REPL/SELECT ø 4,3 h.2 TiN | In distribution | |
| S/ BLOCK N MINI MN ø 3-3,25 h.2 TiN | In distribution | |
| S/BLOCK N NOBEL ACTIVE ø 3 h.6 TiN | In distribution | |
| SPHERO B/N INTRA-LOCK INDEX ø 3,4 h.1 Ti | In distribution | |
| S/BLOCK N ASTRA ACQUA ø3,5-4 h.1 TiN | In distribution | |
| S/ BLOCK NORMO REPL/SELECT ø 3,5 h.6 TiN | In distribution | |
| S/BLOCK N ASTRA ACQUA ø3,5-4 h.4 TiN | In distribution | |
| S/BLOCK NORMO CERTAIN 3I ø 5 h.5 TiN | In distribution | |
| SPHERO BLOCK NORMO EZTETIC ø 3,1 h.4 | In distribution | |
| S/BLOCK NORMO FRIALIT 2 ø 3,8 h.3 TiN | In distribution | |
| SPHERO BLOCK NORMO EZTETIC ø 3,1 h.1 | In distribution | |
| S/BLOCK N INTEG/OMNIL. ø 3,25 h.1 TiN | In distribution | |
| OT EQUATOR REPLACE E/E ø 3,5 h.3 | In distribution | |
| S/BLOCK N ASTRA ST ø 4 h.1 TiN | In distribution | |
| S/ BLOCK NORMO REPL/SELECT ø 5 h.0.5 TiN | In distribution | |
| SPHERO BLOCK N ASTRA EV ø 4,8 h.2 | In distribution | |
| S/B/NORMO BONE LEVEL NC ø 3,3 h.6 TiN | In distribution | |
| S/B/NORMO BONE LEVEL NC ø 3,3 h.5 TiN | In distribution | |
| S/BLOCK NORMO SUSTAIN ø 3,3 h.6 Tin | In distribution | |
| SPHERO BLOCK ANKYLOS C/X h.4 | In distribution | |
| S/BLOCK NORMO INTEGRAL ø 4 h.2 TiN | In distribution | |
| S/BLOCK NORMO SCREW VENT ø 5,7 h.3 TiN | In distribution | |
| SPHERO BLOCK ASTRA EV ø 5,4 h.3 TIN | Withdrawn | |
| S/BLOCK NORMO RESTORE E/E SD h.3 TiN | Withdrawn | |
| S/ BLOCK NORMO NOBEL ACTIVE WP h.3 | Withdrawn | |
| S/B/NORMO BONE LEVEL NC ø 3,3 h.2 TiN | Withdrawn | |
| S/BLOCK NOBEL ACTIVE RP ø 4,3/5 h.6 TiN | Withdrawn |
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.