OT Equator-OT Bridge
171 catalogue numbers from Set OT EQUATOR Frialit 2 ø 3,4 +Smartbox, 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
171catalogue 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 |
| Premarket notification | Exempt |
| Record published | 2020-12-16 |
| Record revised | 2021-01-27 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2021-01-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Set OT EQUATOR Frialit 2 ø 3,4 +Smartbox h.3 | In distribution | |
| Set OT EQUATOR BIO VENT ø 4,5 +Smartbox h.0,5 | In distribution | |
| OT EQUATOR Flat One Gold & Blu h.2 c/SB | In distribution | |
| SET OT EQUATOR ANKYLOS CX h7 | In distribution | |
| Set OT EQUATOR CERTAIN ø 4,1 +Smartbox h.7 | In distribution | |
| Set OT EQUATOR ASTRA ACQUA ø 3,5-4 +Smartbox h.2 | In distribution | |
| OT EQUATOR Flat One Gold & Blu h.4 c/SB | In distribution | |
| Set OT EQUATOR BRANEMARK +Smartbox h.7 | In distribution | |
| Set OT EQUATOR ReplaceSelect ø 3,5 +Smartbox h.4 | In distribution | |
| Set OT EQUATOR SCREW VENT ø 5,7 +Smartbox h.2 | In distribution | |
| OT EQUATOR QZA ø 3,8 h.5 w/SmartBox | In distribution | |
| SET OT EQUATOR NEODENT GM h7 | In distribution | |
| Set OT EQUATOR CERTAIN ø 3,25 +Smartbox h.6 | In distribution | |
| Set OT EQUATOR LUNA RP h.3 | In distribution | |
| Set OT EQUATOR SCREW VENT +Smartbox h.0,5 | In distribution | |
| Set OT EQUATOR ReplaceSelect ø 4,3 +Smartbox h.5 | In distribution | |
| Set OT EQUATOR LUNA RP h.2 | In distribution | |
| Set OT EQUATOR LUNA RP h.5 | In distribution | |
| Set OT EQUATOR CERTAIN ø 4,1 +Smartbox h.4 | In distribution | |
| Set OT EQUATOR ANKYLOS C/X +Smartbox h.7 | In distribution | |
| Set OT EQUATOR ASTRA LILLA ø 4,5-5-5S +Smartbox h.3 | In distribution | |
| Set OT EQUATOR Frialit 2 ø 3,8 +Smartbox h.4 | In distribution | |
| OT EQUATOR QZA ø 3,8 h.5 w/SmartBox | In distribution | |
| Set OT EQUATOR Frialit 2 ø 3,8 +Smartbox h.2 | In distribution | |
| Set OT EQUATOR SPLINE ø 3,25 +Smartbox h.3 | In distribution | |
| Set OT EQUATOR CERTAIN ø 3,25 +Smartbox h.4 | In distribution | |
| Set OT EQUATOR SPLINE ø 3,25 +Smartbox h.2,5 | In distribution | |
| Set OT EQUATOR ReplaceSelect ø 4,3 +Smartbox h.2 | In distribution | |
| Set OT EQUATOR BIO VENT ø 4,5 +Smartbox h.5 | In distribution | |
| Set OT EQUATOR ASTRA LILLA ø 4,5-5-5S +Smartbox h.0 | In distribution | |
| Set OT EQUATOR SCREW VENT +Smartbox h.7 | In distribution | |
| OT EQUATOR C1 Std MIS ø 3,75-4,20 h.1,5 | In distribution | |
| Set OT EQUATOR ANKYLOS C/X +Smartbox h.3 | In distribution | |
| SET OT EQUATOR ASTRA ø 3 h.7 | In distribution | |
| Set OT EQUATOR ASTRA ACQUA ø 3,5-4 +Smartbox h.3 | In distribution | |
| Set OT EQUATOR STRAUMANN +Smartbox h.0,5 | In distribution | |
| Set OT EQUATOR ASTRA LILLA ø 4,5-5-5S +Smartbox h.4 | In distribution | |
| Set OT EQUATOR ReplaceSelect ø 3,5 +Smartbox h.5 | In distribution | |
| OT EQUATOR FOR CONICAL CONN. 4.3 RP h.5 | In distribution | |
| Set OT EQUATOR ASTRA LILLA ø 4,5-5-5S +Smartbox h.6 | In distribution | |
| Set OT EQUATOR ASTRA ACQUA ø 3,5-4 +Smartbox h.6 | In distribution | |
| Set OT EQUATOR ASTRA ACQUA ø 3,5-4 +Smartbox h.7 | In distribution | |
| Set OT EQUATOR LUNA NP h.4 | In distribution | |
| Set OT EQUATOR CERTAIN ø 4,1 +Smartbox h.5 | In distribution | |
| Set OT EQUATOR ReplaceSelect ø 3,5 +Smartbox h.7 | In distribution | |
| Set OT EQUATOR SPLINE ø 3,75-4 +Smartbox h.5 | In distribution | |
| Set OT EQUATOR Frialit 2 ø 4.5 +Smartbox h.2 | In distribution | |
| Set OT EQUATOR ReplaceSelect ø 5 +Smartbox h.0,5 | In distribution | |
| OT EQUATOR FOR CONICAL CONN. 3.5 NP h.6 | In distribution | |
| Set OT EQUATOR SPLINE ø 3,75-4 +Smartbox h.2,3 | In distribution | |
| SET OT EQUATOR CALCITEK INT/OMN ø 3,25 h0.5 | In distribution | |
| SET OT EQUATOR ASTRA ST ø 4 h.5 | In distribution | |
| OT EQUATOR FOR CONICAL CONN. 4.3 RP h.1 | In distribution | |
| Set OT EQUATOR BRANEMARK ø 3,3 +Smartbox h.2,1 | In distribution | |
| Set OT EQUATOR CERTAIN ø 3,25 +Smartbox h.0,5 | In distribution | |
| Set OT EQUATOR LUNA RP h.4 | In distribution | |
| Set OT EQUATOR ANKYLOS C/X +Smartbox h.5 | In distribution | |
| Set OT EQUATOR LUNA NP h.2 | In distribution | |
| Set OT EQUATOR BRANEMARK ø 3,3 +Smartbox h.4 | In distribution | |
| OT EQUATOR FOR CONICAL CONN. 3.5 NP h.5 | In distribution | |
| SET OT EQUATOR INTEGRAL ø 4 h.3 | In distribution | |
| OT EQUATOR FOR CONICAL CONN. 3.5 NP h.3 | In distribution | |
| Set OT EQUATOR Frialit 2 ø 3,8 +Smartbox h.0,5 | In distribution | |
| Set OT EQUATOR Frialit 2 ø 3,4 +Smartbox h.0,5 | In distribution | |
| OT EQUATOR SCREW VENT h.1 | In distribution | |
| OT EQUATOR MIS-SEVEN ø 3,3 NP h.5 | In distribution | |
| Set OT EQUATOR CERTAIN ø 5 +Smartbox h.0,5 | In distribution | |
| Set OT EQUATOR CERTAIN ø 4,1 +Smartbox h.6 | In distribution | |
| SET OT EQUATOR REPLACESELECT ø 6 h0,5 | In distribution | |
| Set OT EQUATOR LUNA NP h.5 | In distribution | |
| OT EQUATOR ASTRA EV ø 5,4 h.5 | In distribution | |
| OT EQUATOR SCREW VENT h.1Set OT EQUATOR BRANEMARK ø 3,3 +Smartbox h.3 | In distribution | |
| Set OT EQUATOR Frialit 2 ø 3,4 +Smartbox h.7 | In distribution | |
| Set OT EQUATOR ASTRA LILLA ø 4,5-5-5S +Smartbox h.2 | In distribution | |
| Set OT EQUATOR ANKYLOS C/X +Smartbox h.6 | In distribution | |
| Set OT EQUATOR NOBEL ACTIVE ø 4,3 +Smartbox h.6 | In distribution | |
| Set OT EQUATOR BRANEMARK +Smartbox h.4 | In distribution | |
| OT EQUATOR STRAUMANN s/bdg | In distribution | |
| Set OT EQUATOR CERTAIN ø 4,1 +Smartbox h.3 | In distribution | |
| Set OT EQUATOR Frialit 2 ø 3,4 +Smartbox h.5 | In distribution | |
| SET OT EQUATOR CALCITEK INT/OML ø 4 h.2 | In distribution | |
| Set OT EQUATOR CERTAIN ø 5 +Smartbox h.1 | In distribution | |
| Set OT EQUATOR CERTAIN ø 3,25 +Smartbox h.7 | In distribution | |
| Set OT EQUATOR Frialit 2 ø 3,4 +Smartbox h.4 | In distribution | |
| Set OT EQUATOR ReplaceSelect ø 3,5 +Smartbox h.1 | In distribution | |
| Set OT EQUATOR ReplaceSelect ø 5 +Smartbox h.1 | In distribution | |
| SET OT EQUATOR ASTRA ST ø 4 h.0,5 | In distribution | |
| OT EQUATOR Flat One Gold & Blu h.6 c/SB | In distribution | |
| OT EQUATOR Flat One Gold & Blu h.3 c/SB | In distribution | |
| SET OT EQUATOR CALCITEK INT/OMN ø 3,25 h.2 | In distribution | |
| Set OT EQUATOR Frialit 2 ø 3,8 +Smartbox h.5 | In distribution | |
| Set OT EQUATOR SPLINE ø 5 +Smartbox h.2 | In distribution | |
| Set OT EQUATOR Frialit 2 ø 3,8 +Smartbox h.1 | In distribution | |
| SET OT EQUATOR CALCITEK INT/OMN ø 3,25 h.1 | In distribution | |
| SET OT EQUATOR RESCUE MEGAGEN h1 | In distribution | |
| OT EQUATOR SCREW VENT h.1 | In distribution | |
| Set OT EQUATOR BRANEMARK +Smartbox h.5 | In distribution | |
| Set OT EQUATOR ASTRA LILLA ø 4,5-5-5S +Smartbox h.5 | In distribution | |
| Set OT EQUATOR NOBEL ACTIVE NP ø3,5 +Smartbox h.7 | In distribution | |
| OT EQUATOR FOR CONICAL CONN. 3.5 NP h.1 | In distribution | |
| Set OT EQUATOR Frialit 2 ø 4.5 +Smartbox h.5 | In distribution | |
| OT EQUATOR FOR CONICAL CONN. 3.5 NP h.4 | In distribution | |
| Set OT EQUATOR SPLINE ø 3,75-4 +Smartbox h.4 | In distribution | |
| Set OT EQUATOR BONE LEVEL RC ø 4,1-4,8 +Smartbox h.7 | In distribution | |
| Set OT EQUATOR ASTRA ACQUA ø 3,5-4 +Smartbox h.5 | In distribution | |
| Set OT EQUATOR Frialit 2 ø 4.5 +Smartbox h.1 | In distribution | |
| Set OT EQUATOR BRANEMARK ø 3,3 +Smartbox h.7 | In distribution | |
| OT EQUATOR FOR CONICAL CONN. 4.3 RP h.3 | In distribution | |
| Set OT EQUATOR Frialit 2 ø 3,8 +Smartbox h.6 | In distribution | |
| OT EQUATOR NOBEL ACTIVE NP ø3,5 h.3 c/SB | In distribution | |
| SET OT EQUATOR CALCITEK INT/OML ø 4 h.1 | In distribution | |
| Set OT EQUATOR BRK/Restore WP ø 5 +Smartbox h.2 | In distribution | |
| Set OT EQUATOR ReplaceSelect ø 4,3 +Smartbox h.4 | In distribution | |
| Set OT EQUATOR BONE LEVEL RC ø 4,1-4,8 +Smartbox h.6 | In distribution | |
| OT EQUATOR C1 Std MIS ø 3,75-4,20 h.2 | In distribution | |
| Set OT EQUATOR CERTAIN ø 5 +Smartbox h.5 | In distribution | |
| Set OT EQUATOR ReplaceSelect ø 4,3 +Smartbox h.1 | In distribution | |
| OT EQUATOR STRAUMANN h.1 | In distribution | |
| OT EQUATOR FOR CONICAL CONN. 4.3 RP h.2 | In distribution | |
| OT EQUATOR NOBEL ACTIVE NP ø3,5 h.2 c/SB | In distribution | |
| Set OT EQUATOR CERTAIN ø 5 +Smartbox h.3 | In distribution | |
| SET OT EQUATOR CALCITEK INT/OMN ø 3,25 h.3 | In distribution | |
| OT EQUATOR FOR CONICAL CONN. 4.3 RP h.4 | In distribution | |
| Set OT EQUATOR NOBEL ACTIVE ø 4,3 +Smartbox h.5 | In distribution | |
| Set OT EQUATOR LUNA NP h.1 | In distribution | |
| Set OT EQUATOR ASTRA LILLA ø 4,5-5-5S +Smartbox h.1 | In distribution | |
| SET OT EQUATOR SILHOUETTE IC ø 4 h1 | In distribution | |
| Set OT EQUATOR Frialit 2 ø 3,4 +Smartbox h.2 | In distribution | |
| SET OT EQUATOR CALCITEK INT/OML ø 4 h.3 | In distribution | |
| Set OT EQUATOR ASTRA LILLA ø4,5-5-5S h0,5 | In distribution | |
| Set OT EQUATOR ReplaceSelect ø 3,5 +Smartbox h.3 | In distribution | |
| Set OT EQUATOR LEGACY ø 3 +Smartbox h.5 | In distribution | |
| Set OT EQUATOR ANKYLOS C/X +Smartbox h.1 | In distribution | |
| Set OT EQUATOR BONE LEVEL RC ø 4,1-4,8 +Smartbox h.2 | In distribution | |
| SET OT EQUATOR CALCITEK INT/OMN ø 3,25 h.7 | In distribution | |
| Set OT EQUATOR Frialit 2 ø 3,8 +Smartbox h.3 | In distribution | |
| SET OT EQUATOR MIS SEVEN ø 3.75 4.2 h7 | In distribution | |
| Set OT EQUATOR LUNA NP h.3 | In distribution | |
| Set OT EQUATOR ASTRA ACQUA ø 3,5-4 +Smartbox h.4 | In distribution | |
| Set OT EQUATOR SPLINE ø 3,75-4 +Smartbox h.3 | In distribution | |
| OT EQUATOR SCREW VENT h.2 | In distribution | |
| Set OT EQUATOR BRANEMARK +Smartbox h.6 | In distribution | |
| Set OT EQUATOR CERTAIN ø 4,1 +Smartbox h.2 | In distribution | |
| Set OT EQUATOR Frialit 2 ø 3,8 +Smartbox h.7 | In distribution | |
| OT EQUATOR FOR CONICAL CONN. 3.5 NP h.2 | In distribution | |
| Set OT EQUATOR BIO VENT ø 4,5 +Smartbox h.3 | In distribution | |
| OT EQUATOR FOR CONICAL CONN. 4.3 RP h.6 | In distribution | |
| Set OT EQUATOR SPLINE ø 3,75-4 +Smartbox h.7 | In distribution | |
| Set OT EQUATOR CERTAIN ø 5 +Smartbox h.2 | In distribution | |
| Set OT EQUATOR ANKYLOS C/X +Smartbox h.2 | In distribution | |
| Set OT EQUATOR CERTAIN ø 4,1 +Smartbox h.0,5 | In distribution | |
| Set OT EQUATOR ANKYLOS C/X +Smartbox h.4 | In distribution | |
| SET OT EQUATOR SCREW VENT h7 | In distribution | |
| Set OT EQUATOR ReplaceSelect ø 4,3 +Smartbox h.0,5 | In distribution | |
| Set OT EQUATOR ASTRA ACQUA ø 3,5-4 +Smartbox h.1 | In distribution | |
| Set OT EQUATOR ASTRA ACQUA ø 3,5-4g | In distribution | |
| SET OT EQUATOR INTEGRAL ø 4 h.1 | In distribution | |
| Set OT EQUATOR Frialit 2 ø 3,4 +Smartbox h.1 | In distribution | |
| Set OT EQUATOR Frialit 2 ø 4.5 +Smartbox h.3 | In distribution | |
| Set OT EQUATOR LUNA RP h.1 | In distribution | |
| Set OT EQUATOR BIO VENT ø 4,5 +Smartbox h.7 | In distribution | |
| Set OT EQUATOR ReplaceSelect ø 4,3 +Smartbox h.3 | In distribution | |
| OT EQUATOR ASTRA EV ø 5,4 h.3 | In distribution | |
| OT EQUATOR STRAUMANN h.3 c/Smart Box | Withdrawn | |
| OT EQUATOR ASTRA EV ø 5,4 h.3 | Withdrawn | |
| OT EQUATOR NOBEL ACTIVE NP ø 3,5 h.4 | Withdrawn | |
| OT EQUATOR ReplaceSelect ø 6 h.1 | Withdrawn | |
| OT EQUATOR STRAUMANN h.4 c/Smart Box | Withdrawn | |
| OT EQUATOR ReplaceSelect ø 4,3 h.2 | Withdrawn | |
| SPHERO BLOCK N h.0,5 (da Vs. campione) | Withdrawn | |
| S/STEEL HOUSING x OT EQUATOR | 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.