OT Equator

Set of devices intended to be incorporated into a dental prosthesis and fix it onto OT Equators attachments already present into the patient's mouth.

Registry build 21.09.26
1manufacturer
26catalogue numbers in this listing

Who Else Makes It

Registered in Hunan.

Chinese manufacturers registered for FDA product code EJX
Manufacturer City Province Registered as Device types
Changsha Nice Medical Instrument Limited Company Changsha Hunan Manufacturer 17

Record

Regulatory record for OT Equator
Listed by Rhein 83 SRL, Italy
FDA product code EJX
Device type Anchor, Preformed
Device class Class 1
Regulation 21 CFR 872.3130
Establishment Contract manufacturer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2025-07-07

Specifications

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 numbers for OT Equator
Catalogue number Size Status
CASTABLE EXTRAGRADE+SCREW+SEEGER In distribution
TITANIUM SCREW ABUTMENT MINI EXTRAGRADE In distribution
SEALING SCREW EASY FIX In distribution
Castab. sleeve for ø4 15° incl. abut. 1u In distribution
KIT PEEK PINK SEEGER #4 In distribution
HIGH CASTABLE SLEEVE EASY FIX In distribution
WIRE FOR CMTFP/CMTB30FP/MTFP/MTB30FP ø1 In distribution
TITANIUM HOUSING EASY FIX In distribution
T-BASE EASY FIX In distribution
KIT PEEK IVORY SEEGER #4 In distribution
HIGH T-BASE EASY FIX In distribution
KIT PEEK BLACK SEEGER #4 In distribution
KIT SEEGER EASY FIX In distribution
KIT PEEK WHITE SEEGER #4 In distribution
HIGH TITANIUM WORKING SCREW EASY FIX In distribution
EXTRAGRADE 15°+VITE+SEEGER ø3.5 In distribution
CASTABLE SLEEVE for Tit. Abutm. 1 pcs. In distribution
CASTABLE SLEEVE EASY FIX In distribution
CASTABLE HOUSING 1 pcs. In distribution
LOCKING SCREW EASY FIX In distribution
KIT EASY FIX In distribution
MINI EXTRAGRADE+SCREW+SEEGER ø4 In distribution
SHORT TITANIUM SCREW for OT Fix In distribution
TITANIUM SCREW SELF-EXTRACTING SEEGER h3 In distribution
CASTABLE HOUSING 1 pcs. In distribution
TITANIUM SPACING SCREW EASY FIX In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Dalbo®-PLUS Cendres+Métaux SA 18
Keystone Industries Keystone Industries 14
CM LOC® Cendres+Métaux SA 13
OT Equator-Easy FIX Rhein 83 SRL 6
Separable Fastener Assembly 10PK – Drill Kit Included Smart Denture Conversions, LLC 5
Dalbo®-Z Cendres+Métaux SA 4
Gerber RZ Cendres+Métaux SA 3
Smileloc® BY Rodo Rodo Medical, Inc 3
Dalbo®-B Cendres+Métaux SA 2
Leixir Recharge Kit, Unigrip Smart Denture Conversions, LLC 1
Tall Spare Parts Kit, Omnibut Smart Denture Conversions, LLC 1
Tall TiBase 10PK, Omnibut Smart Denture Conversions, LLC 1

Showing 12 of 79. All products under Anchor, Preformed

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