OT Equator-OT Bridge

459 catalogue numbers from EXTRAGR. Ø4 CAST. AB. W/LONG SCREW & SEE, listed by Rhein 83 SRL, Italy, under Accessories, Implant, Dental, Endosseous. 70 manufacturers in China are registered for this product code.

Registry build 21.09.26
70manufacturers in China registered for this device type
459catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (28), Jiangsu (9), Zhejiang (6). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NDP
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
iBrite Suzhou Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 18
Digital Dental Depot Zhuhai Guangdong Contract manufacturer 17
Xiamen Yizhou IMP. & EXP. Co., Ltd. Xiamen Fujian Contract manufacturer 10
Amedcon Medical Technology (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 7
Ningbo Sezen Technology Co., Ltd. Ningbo Zhejiang Contract manufacturer 7
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99
Shanghai Lions Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 82
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66

Showing 12 of 70. All 70 manufacturers in China registered for Accessories, Implant, Dental, Endosseous

Record

Regulatory record for OT Equator-OT Bridge
Listed by Rhein 83 SRL, Italy
FDA product code NDP
Device type Accessories, Implant, Dental, Endosseous
Device class Class 1
Regulation 21 CFR 872.3980
Establishment Contract manufacturer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2020-12-18
Record revised 2024-06-19 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date, manufacturing date, serial number
Distribution end date 2021-07-22

Catalogue Numbers

Catalogue numbers for OT Equator-OT Bridge
Catalogue number Size Status
EXTRAGR. Ø4 CAST. AB. W/LONG SCREW & SEEG. In distribution
OT EQUATOR CASTABLE MALES pcs.2 In distribution
ODSECURE PROSTHETIC SCREW, REGULAR In distribution
ODSECURE ANGLED TITANIUM COPING, REGULAR In distribution
TIT. AB. h.3 W/LAT. HOLES W/SCREW & SEEG. In distribution
OT EQUATOR ASTRA EV ø 4,8 h.5 In distribution
TITANIUM MALE SCAN BODY In distribution
LABORATORY ANALOG Ø5 In distribution
INSERITORE di CAPP. NORMO e MICRO c/ UDI In distribution
OT EQUATOR SHORT SCREWDRIVER with HOLDER In distribution
EXTRAGR. EXTRA-SHORT TIT. SCREW In distribution
EXTRAGR. LONG TIT. SCREW In distribution
SHORT SCREWDR./STEM FOR ANGULATED HOLE In distribution
OT EQUATOR SCAN ABUTMENT W/SCREW In distribution
ODSECURE ANGLED TITANIUM COPING, NARROW In distribution
OT EQUATOR LONG SCREWING KEY with HOLDER In distribution
ODSECURE PROSTHETIC SCREW, SHORT In distribution
EXTRAGR. Ø3,5 TIT. AB. W/SCREW & SEEG. In distribution
ODSECURE SHORT TITANIUM COPING, NARROW In distribution
TIT. AB. h.1,8 W/LAT. HOLES W/SCREW & SEEG. In distribution
ODSECURE PROSTHETIC SCREW, LONG In distribution
OT EQUATOR ASTRA EV ø 5,4 h.4 In distribution
LABORATORY ANALOG Ø4 In distribution
EQUATOR SCREWING KEY with HOLDER In distribution
POLISHER BUR FOR SEEGER HOUSINGS In distribution
OT EQUATOR SCREW FOR SCAN ABUTMENT In distribution
EXTRAGR. Ø3,5 15° TIT. AB. W/SCREW & SEEG. In distribution
ANALOG Ø5 W/SCREW FOR CAD/CAM MODEL In distribution
EXTRAGR. Ø3,5 TIT. AB. 1u. In distribution
CASTABLE SLEEVE Ø4 1 u. In distribution
ODSECURE DIRECT PICK-UP COPING In distribution
OT EQUATOR SHORT IMPRESS. COPING W/SCREW In distribution
ANALOG Ø4 W/SCREW FOR CAD/CAM MODEL In distribution
PINK SEEGERS W/HANDLE 6 u. In distribution
ODSECURE TITANIUM COPING, REGULAR In distribution
ODSECURE PROSTHETIC SCREW, ANGLED In distribution
ODSECURE SNAP RING, SOFT In distribution
EXTRAGR. Ø4 TIT. AB. W/SCREW & SEEG. In distribution
ODSECURE TITANIUM COPING, NARROW In distribution
EXTRAGR. Ø5 TIT. AB. 1u. In distribution
TIT. ABUTMENT h.3 W/LAT. HOLES 1u. In distribution
ODSECURE SNAP RING, REGULAR In distribution
CASTABLE SLEEVE Ø5 1 u. In distribution
ODSECURE SCAN BODY In distribution
OT EQUATOR SCREW AND TIT. HEALING RING In distribution
EXTRAGR. Ø4 TIT. AB. INTR. WELD. W/SCREW & SEEG. In distribution
INSERTION/EXTRACTION TOOL FOR CAPS In distribution
EXTRAGR. Ø4 15° TIT. AB. 1u. In distribution
TITANIUM SCREW SCAN BODY In distribution
OT EQUATOR ASTRA EV ø 5,4 h.2 In distribution
EXTRAGR. Ø4 NO HOLE CAST. AB. W/SEEG. In distribution
TRI® Raptor insertion and extractor tool for caps In distribution
OT EQUATOR ASTRA EV ø 4,8 h.4 In distribution
MINI EXTRAGR. Ø3,5 TIT. AB. W/SCREW & SEEG. In distribution
EXTRAGR. Ø4 TIT. AB. 1u. In distribution
EXTRAGR. Ø4 CAST. AB. W/HOLE In distribution
TIT. SCREW AND TIT. HEALING RING In distribution
OT Equator analog for lab In distribution
EXTRAGR. SHORT TIT. SCREW In distribution
OT EQUATOR ASTRA EV ø 5,4 h.1,5 In distribution
OT EQUATOR WHITE MINI IMPRESS. COPING In distribution
ODSECURE SHORT TITANIUM COPING, REGULAR In distribution
ODSECURE SNAP RING TOOL In distribution
EXTRAGR. Ø4 NO HOLE CAST. AB. 1u. In distribution
EQUATOR LABORATORY ANALOG (4 Pack) In distribution
WHITE SEEGERS W/HANDLE 6 u. In distribution
LONG SCREWDR./STEM FOR ANGULATED HOLE In distribution
LAB ANALOGUE ILZ In distribution
EXTRAGR. Ø4 TIT. AB. 15° W/SCREW & SEEG. In distribution
EXTRAGR. Ø4 CAST. AB. W/SCREW & SEEG. In distribution
CAPS EXTR./INSERTION TOOL W. UDI In distribution
OT EQUATOR ASTRA EV ø 4,8 h.3 In distribution
LABORATORY ANALOG Ø5 In distribution
SQUARE HANDPIECE CONNECTOR In distribution
ODSECURE TITANIUM COPING, WIDE In distribution
EXTRAGR. MEDIUM TIT. SCREW In distribution
OT EQUATOR HOLDER In distribution
EQUATOR/OT CAPS INSERTER/EXTRACTOR TOOL In distribution
BLUE PLASTIC “MULTIUSE”INSERTION TOOL In distribution
CASTABLE EQUATOR MALE 50 u. In distribution
EXTRAGR. Ø3,5 15° TIT. AB. 1u. In distribution
SPHERICAL TIT. SCREW FOR INCLINED ABUTMENT In distribution
IMPRESSION COPINGS 100 U. In distribution
OT EQUATOR SCREW FOR TIT. HEALING RING In distribution
OT EQUATOR LONG IMPRESS. COPING W/SCREW In distribution
OT EQUATOR WHITE IMPRESS. COPING In distribution
CASTABLE SLEEVE Ø3,5 1 u. In distribution
LAB ANALOGUE EQ In distribution
CASTABLE SLEEVE Ø3,5-4 FOR INCLINED AB. 1 u. In distribution
TIT. ABUTMENT h.1,8 W/LAT. HOLES 1u. In distribution
CAP INSERT/EXTRAC.TOOL EQUATOR In distribution
ADAPTER FOR SCREWDRIVER/STEM In distribution
EXTRAGR. Ø5 TIT. AB. W/SCREW & SEEG. In distribution
OT EQUATOR ANKYLOS C/X h.3 Withdrawn
OT EQUATOR STRAUMANN h.2 c/Smart Box Withdrawn
OT EQUATOR STRAUMANN h.1 c/Smart Box Withdrawn
OT EQUATOR STRAUMANN WN h.2 Withdrawn
OT EQUATOR PRIMA CONNEX SD ø 3,5 h.1 Withdrawn
OT EQUATOR NOBEL ACTIVE ø 3 h.7 Withdrawn
OT EQUATOR BRK/Restore WP ø 5 h.2 Withdrawn
OT EQUATOR ReplaceSelect ø 3,5 h.0,5 Withdrawn
OT EQUATOR LITTLE IMPLANT ø 3,5 h.4 Withdrawn
INSERTION/EXTRACTION TOOL FOR CAPS Withdrawn
ODSecure Analog 500 u. Withdrawn
ODSecure Housing Caps Withdrawn
OT EQUATOR BIO VENT ø 4,5 h.1 Withdrawn
OT EQUATOR Straumann N/NECK ø 3,5 h.3 Withdrawn
OT EQUATOR N BONE LEVEL SC ø 2,9 h.2 Withdrawn
OT EQUATOR SCREW VENT h.6 Withdrawn
2MM THREADED EQUATOR Withdrawn
OT EQUATOR ANYRIDGE h.3 c/SmartBox Withdrawn
OT EQUATOR ASTRA ø 3 h.2 Withdrawn
OT EQUATOR MIS – SEVEN ø 3,75-4,2 h.4 Withdrawn
OT EQUATOR REPLACE E/E ø 3,5 h.2,2 Withdrawn
OT EQUATOR BIO VENT ø 4,5 h.0,5 Withdrawn
OT EQUATOR ANYRIDGE h.1 c/SmartBox Withdrawn
OT EQUATOR GL Impl/System C-TECH h.4 Withdrawn
OT EQUATOR PRIMA CONNEX RD ø 4,1 h.3 Withdrawn
OT EQUATOR PRIMA CONNEX RD ø 4,1 h.4 Withdrawn
EQUATOR SMART BOX + ASSORTED CAPS kit Withdrawn
EQUATOR RET.CAPS STRONG,VIOLET (4-pack) Withdrawn
OT EQUATOR ASTRA LILLA ø 4,5-5-5S h.4 Withdrawn
OT EQUATOR ASTRA ACQUA ø 3,5-4 h.1 Withdrawn
OT EQUATOR NOBEL ACTIVE NP ø 3,5 h.2 Withdrawn
OT EQUATOR ASTRA EV ø 4,2 h.7 Withdrawn
OT EQUATOR CERTAIN ø 4,1 h.1 Withdrawn
OT EQUATOR BRANEMARK h.2 Withdrawn
OT EQUATOR CERTAIN ø 4,1 h.3 Withdrawn
OT EQUATOR ASTRA ST ø 4 h.1 Withdrawn
OT EQUATOR IMZ ø 3,3 h.2 Withdrawn
OT EQUATOR ReplaceSelect ø 4,3 h.4 Withdrawn
OT EQUATOR TSII-GSII Mini ø 3,5 h.5 Withdrawn
OT EQUATOR ANYRIDGE h.2 Withdrawn
OT EQUATOR STRAUMANN WN h.4 Withdrawn
YELLOW OT EQUATOR CAP 500 u. Withdrawn
OT EQUATOR LEGACY ø 3 h.4 Withdrawn
OT EQUATOR SCREW VENT h.3 Withdrawn
OT EQUATOR INTRA LOCK SQ ø 3,3 h.4 c/SB Withdrawn
OT EQUATOR TRE ø 3,25 E/E h.3 Withdrawn
OT EQUATOR CERTAIN ø 3,25 h.7 Withdrawn
OT EQUATOR SCREW VENT h.5 Withdrawn
CASTABLE EQUATOR MALE 50 u. Withdrawn
OT EQUATOR MINI MN ø 3 h.2 Withdrawn
OT EQUATOR ANYRIDGE h.6 c/SmartBox Withdrawn
OT EQUATOR NEODENT CM h.4 Withdrawn
TITANIUM ANALOG ø 4 BH Withdrawn
OT EQUATOR Flat One Gold & Blu h.1 Withdrawn
EQUATOR FIL. in TIT. M2 ESAG. TiN Withdrawn
OT EQUATOR CERTAIN ø 3,25 h.5 Withdrawn
OT EQUATOR ANYRIDGE h.4 Withdrawn
OT EQUATOR h.0,5 (as yr.sample) Withdrawn
OT EQUATOR ASTRA ø 3 h.3 Withdrawn
OT EQUATOR TSII-GSII Mini ø 3,5 h.6 Withdrawn
OT EQUATOR BIO VENT ø 4,5 h.4 Withdrawn
OT EQUATOR BIO HORIZONS ø 3 h.3 Withdrawn
OT EQUATOR ASTRA ACQUA ø 3,5-4 h.5 Withdrawn
OT EQUATOR NOBEL ACTIVE ø 3 h.6 Withdrawn
OT EQUATOR ReplaceSelect ø 3,5 h.5 Withdrawn
OT EQUATOR SCREW VENT h.7 c/TAS, Withdrawn
EQUATOR FIL. TIT. MUA M1,8 TiN Withdrawn
OT EQUATOR ASTRA ø 3 h.6 Withdrawn
OT EQUATOR CERTAIN ø 5 h.4 Withdrawn
OT EQUATOR ASTRA ACQUA ø 3,5-4 h.6 Withdrawn
S/STEEL HOUSING OT EQUATOR 100 u. Withdrawn
OT EQUATOR ASTRA EV ø 4,8 h.2 c/SB Withdrawn
OT EQUATOR BRANEMARK h.3 c/SmartBox Withdrawn
OT EQUATOR ASTRA EV ø 3 h.3 c/SB Withdrawn
OT EQUATOR CoAxis H/E ø 3,25 h.3 Withdrawn
OT EQUATOR ASTRA EV ø 3 h.1 c/SB Withdrawn
OT EQUATOR TRI NEX ø 5 h.1 Withdrawn
OT EQUATOR SCREW VENT h.2 Withdrawn
OT EQUATOR PRIMA CONNEX SD ø 3,5 h.2 Withdrawn
OT EQUATOR STERI OSS E/E ø 3,25 h.3 c/SB Withdrawn
OT EQUATOR IMPRESSION COPING CAP Withdrawn
OT EQUATOR BRANEMARK h.3 Withdrawn
OT EQUATOR LEGACY ø 3 h.5 Withdrawn
OT EQUATOR BONE LEVEL NC ø 3,3 h.2 Withdrawn
OT EQUATOR PREMIUM ø 3,3 h.5 Withdrawn
OT EQUATOR ASTRA EV ø 5,4 h.7 Withdrawn
OT EQUATOR MIS-SEVEN ø 3,3 NP h.5 Withdrawn
OT EQUATOR CERTAIN ø 3,25 h.1 Withdrawn
OT EQUATOR Frialit 2 ø 4.5 h.7 Withdrawn
OT EQUATOR ANKYLOS C/X h.6 Withdrawn
OT EQUATOR STRAUMANN h.7 c/SB Withdrawn
OT EQUATOR ANKYLOS C/X h.2 Withdrawn
OT EQUATOR NOBEL ACTIVE NP ø3,5 h.1 c/SB Withdrawn
OT EQUATOR ASTRA EV ø 5,4 h.5 Withdrawn
OT EQUATOR INTRA LOCK ø 3,3 h.3 Withdrawn
OT EQUATOR NOBEL ACTIVE ø 3 h.1.1 Withdrawn
OT EQUATOR ELASTIC SELF-EXTR. SEEGER kit Withdrawn
OT EQUATOR LITTLE IMPLANT ø 3,5 h.5 Withdrawn
OT EQUATOR MINI MN ø 3 h.6 c/SmartBox Withdrawn
OT EQUATOR PRIMA CONNEX RD ø 4,1 h.2 Withdrawn
OT EQUATOR TSII-GSII Mini ø 3,5 h.2 Withdrawn
OT EQUATOR CERTAIN ø 6 h.3 Withdrawn
OT EQUATOR Flat One Gold & Blu h.1 c/SB Withdrawn
OT EQUATOR ReplaceSelect ø 3,5 h.2 Withdrawn
OT EQUATOR ReplaceSelect ø 6 h.3 Withdrawn
OT EQUATOR CERTAIN ø 4,1 h.5 Withdrawn
OT EQUATOR NOBEL ACTIVE NP ø 3,5 h.6 Withdrawn
EQUATOR RET.CAPS STANDARD,CLEAR (4-Pack) Withdrawn
OT EQUATOR STRAUMANN h.4 Withdrawn
OT EQUATOR Frialit 2 ø 3 h.4 Withdrawn
OT EQUATOR STERI OSS E/E ø 3,25 h.2 c/SB Withdrawn
OT EQUATOR STRAUMANN h.5 c/Smart Box Withdrawn
OT EQUATOR Frialit 2 ø 3 h.1 Withdrawn
OT EQUATOR NOBEL ACTIVE ø 4,3 h.7 Withdrawn
OT EQUATOR NOBEL ACTIVE ø 4,3 h.1 c/SB Withdrawn
OT EQUATOR INTRA LOCK SQ ø 3,3 h.2 c/SB Withdrawn
OT EQUATOR MINI MN ø 3 h.4 Withdrawn
OT EQUATOR MINI MN ø 3 h.1 c/SmartBox Withdrawn
OT EQUATOR MIS-SEVEN ø 3,3 NP h.3 Withdrawn
OT EQUATOR GL Impl/System C-TECH h.5 Withdrawn
EQUATOR CAPS LAB.PROCESSING, BLACK (4 p) Withdrawn
OT EQUATOR CERTAIN ø 3,25 h.4 Withdrawn
OT EQUATOR ANYRIDGE h.4 c/SmartBox Withdrawn
OT EQUATOR MINI MN ø 3 h.2 c/SmartBox Withdrawn
OT EQUATOR NOBEL ACTIVE ø 4,3 h.2 c/SB Withdrawn
OT EQUATOR GREEN CAP ø int.mm.2,2 x4 Withdrawn
OT EQUATOR NEODENT CM h.3 Withdrawn
OT EQUATOR BIO VENT ø 4,5 h.7 Withdrawn
OT EQUATOR TSII-GSII Mini ø 3,5 h.4 Withdrawn
OT EQUATOR NEODENT DRIVE CM h.2 c/SB Withdrawn
OT EQUATOR ReplaceSelect ø 5 h.1 Withdrawn
OT EQUATOR SMART BOX 1 unit Withdrawn
OT EQUATOR ASTRA LILLA ø 4,5-5-5S h.2 Withdrawn
OT EQUATOR BONE LEVEL NC ø 3,3 h.3 Withdrawn
OT EQUATOR ReplaceSelect ø 4,3 h.0.5 Withdrawn
OT EQUATOR STERI OSS ø 3,25 h.2 c/smartb Withdrawn
OT EQUATOR SCREW VENT h.0,5 Withdrawn
OT EQUATOR ASTRA EV ø 5,4 h.1,5 Withdrawn
S/BLOCK NORMO SUSTAIN ø 3,3 h.6 Tin Withdrawn
EQUATOR RET.CAPS SOFT,YELLOW (4 Pack) Withdrawn
OT EQUATOR ReplaceSelect ø 5 h.6 Withdrawn
OT EQUATOR INTRA LOCK ø 3,3 h.7 c/SB Withdrawn
OT EQUATOR ReplaceSelect ø 3,5 h.3 Withdrawn
OT EQUATOR ReplaceSelect ø 4,3 h.5 Withdrawn
OT EQUATOR TRE ø 3,25 E/E h.4 Withdrawn
OT EQUATOR ANKYLOS C/X h.4 Withdrawn
OT EQUATOR SI External Hex ø 3,25 h.2 Withdrawn
OT EQUATOR NEOSS h.3 c/SmartBox Withdrawn
OT EQUATOR ASTRA EV ø 5,4 h.6 Withdrawn
OT EQUATOR LEGACY ø 3 h.6 Withdrawn
OT EQUATOR BIO HORIZONS ø 4 h.4 Withdrawn
OT EQUATOR BONE LEVEL NC ø 3,3 h.5 Withdrawn
BLACK CAPS for EQUATOR (for lab.only) Withdrawn
OT EQUATOR NOBEL ACTIVE ø 5 h.4 Withdrawn
OT EQUATOR CERTAIN ø 3,25 h.2 Withdrawn
OT EQUATOR ReplaceSelect ø 5 h.5 Withdrawn
OT EQUATOR Flat One Gold & Blu h.5 Withdrawn

Showing 250 of 300 catalogue numbers.

Same Product Code

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Product Sold by Catalogue numbers
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Inclusive Prismatik Dentalcraft, Inc. 1,045
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BioHorizons Biohorizons Implant Systems Inc. 1,008
IPD Implant Protesis Dental 2004 SL 998
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MIS MIS Implants Technologies Ltd. 615

Showing 12 of 7,548. All products under Accessories, Implant, Dental, Endosseous

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer