FDA.reportPublic FDA data

OT EQUATOR-EASY FIX

Primary DI
08059224208152
Brand
OT EQUATOR-EASY FIX
Company
RHEIN 83 SRL
Model
4 EASY FIX T-BASE h4
Catalog number
KEF4MEF
Device description
Accessories for dental prosthesis
Published
2026-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EJXAnchor, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJXAnchor, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08059224208152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059224208152080592242081528059224208152

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
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08059224208183TITANIUM EASY FIX T-BASE h9RHEIN 83 SRLEJX2026-06-23
07640239932098Dalbo®-PLUSCendres+Métaux SAEJX2026-02-16
07640239932104Dalbo®-PLUSCendres+Métaux SAEJX2026-02-16
08059224207810OT EQUATOR-EASY FIXRHEIN 83 SRLEJX2026-02-10
08059224208169OT EQUATOR-EASY FIXRHEIN 83 SRLEJX2026-02-10
08059224001661OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224108865OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224136905OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224165189OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224165196OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224165202OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224166117OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224168135OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224168173OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224168180OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224169910OT EQUATORRHEIN 83 SRLEJX2025-07-07
D990CTB1PK0Cementable TiBase 1PKSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB10PK0Pre-Coated TiBase 10PKSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB10PKEX0Pre-Coated TiBase 10PK, Ext. ThreadSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB10PKIT0Pre-Coated TiBase 10PK, Integrated ThreadSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB10PKOA0Pre-Coated TiBase 10PK, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB1PK0Pre-Coated TiBase 1PKSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB1PKEX0Pre-Coated TiBase 1PK, Ext. ThreadSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB1PKIT0Pre-Coated TiBase 1PK, Integrated ThreadSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB1PKOA0Pre-Coated TiBase 1PK, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990RKOA0Recharge Kit w/ Tall Spare Parts, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990RKPOCOA0Recharge Kit w/ POC, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990SFA10PKDKOA0Separable Fastener Assembly 10PK - Drill Kit Included, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990STB1PK0Standard TiBase 1PKSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990STB1PKOA0Standard TiBase 1PK, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19