FDA.reportPublic FDA data

OT EQUATOR

Primary DI
08059224214436
Brand
OT EQUATOR
Company
RHEIN 83 SRL
Model
OT EQUATOR NEODENT GM h.6
Catalog number
030NGM6-IQ
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
08059224214436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059224214436080592242144368059224214436

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
08059224150611OT EQUATORSET OT EQUATOR YV-N H.4130YVN42026-06-23
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

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