FDA.reportPublic FDA data

OT EQUATOR

Primary DI
08059224150611
Brand
OT EQUATOR
Company
RHEIN 83 SRL
Model
SET OT EQUATOR YV-N H.4
Catalog number
130YVN4
Device description
The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.
Published
2026-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08059224150611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059224150611080592241506118059224150611

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
439240722
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08059224127897OT EQUATOROT EQUATOR YELLOW CAP #100CN053-1002026-06-23
08059224136097OT equatorOT EQUATOR INOX BOX #500CA008-5002026-06-23
08059224140179OT EQUATORSET OT EQUATOR C1 STD MIS h3 +S.BOX131C1S32026-06-23
08059224141718OT EQUATOROT EQUATOR DIO UF NARROW ø 3-3.3 h3030DIU332026-06-23
08059224150536OT EQUATORSET OT EQUATOR YI H.1130YI12026-06-23
08059224150543OT EQUATORSET OT EQUATOR YI H.2130YI22026-06-23
08059224150550OT EQUATORSET OT EQUATOR YI H.3130YI32026-06-23
08059224150567OT EQUATORSET OT EQUATOR YI H.4130YI42026-06-23
08059224150574OT EQUATORSET OT EQUATOR YI H.5130YI52026-06-23
08059224150581OT EQUATORSET OT EQUATOR YV-N H.1130YVN12026-06-23
08059224150598OT EQUATORSET OT EQUATOR YV-N H.2130YVN22026-06-23
08059224150604OT EQUATORSET OT EQUATOR YV-N H.3130YVN32026-06-23
08059224150628OT EQUATORSET OT EQUATOR YV-N H.5130YVN52026-06-23
08059224150635OT EQUATORSET OT EQUATOR YV-N H.6130YVN62026-06-23
08059224150642OT EQUATORSET OT EQUATOR YV-R H.2130YVR22026-06-23
08059224150659OT EQUATORSET OT EQUATOR YV-R H.3130YVR32026-06-23
08059224150666OT EQUATORSET OT EQUATOR YV-R H.4130YVR42026-06-23
08059224150673OT EQUATORSET OT EQUATOR YV-R H.5130YVR52026-06-23
08059224150680OT EQUATORSET OT EQUATOR YV-R H.6130YVR62026-06-23
08059224151472OT EQUATORSET OT EQUATOR YI H.6130YI62026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899995243898FIXATION SCREW CM11.5° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243904FIXATION SCREW CM11.5° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243928PARAF. DE FIXACAO MT16° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243935PARAF. DE FIXACAO MT16° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
08806388266173ZrGEN AbutmentMegagen Implant Co. LtdNHA2024-01-31
08806388244812ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244829ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244836ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244843ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244850ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244867ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244874ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244898ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244904ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244911ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244928ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244935ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244942ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244959ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244966ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256624ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256631ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256648ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256655ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260690ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260706ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260737ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260744ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260966ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260973ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22