FDA.reportPublic FDA data

OT EQUATOR

Primary DI
08059224168173
Brand
OT EQUATOR
Company
RHEIN 83 SRL
Model
CASTABLE SLEEVE for Tit. Abutm. 1 pcs.
Catalog number
GC
Device description
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.
Published
2025-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
08059224168173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059224168173080592241681738059224168173

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08059224214320OT EQUATORTianium screw Scan Ladder #8VSL82026-05-27
08059224214344OT EQUATORTianium screw Scan Ladder #1VSL12026-05-27
08059224094229OT EQUATOR TITANIUM ABUTMENT OT EQUATOR XIVE TG h.3230XIVTG32026-02-10
08059224115801PLUSPLUS CAP EXTRACTOR-INSERTER488EIP2026-02-10
08059224127798OT EQUATOROT EQUATOR CLEAR CAP #100CN051-1002026-02-10
08059224129044PLUSPINK CAP PLUS #50CN087-502026-02-10
08059224129099PLUSYELLOW CAP PLUS #50CN088-502026-02-10
08059224129143PLUSVIOLET CAP PLUS #50CN089-502026-02-10
08059224133041OT EQUATORPINK PROTECTIVE DISK #100DPR-1002026-02-10
08059224133058OT EQUATORPINK PROTECTIVE DISK #50DPR-502026-02-10
08059224134260OT EQUATORSMART BOX OT EQUATOR #50SBE-502026-02-10
08059224140148OT EQUATORLABORATORY ANALOGS 50 u.AAE-502026-02-10
08059224167497PLUSTransfer Heli-Loc open044CAIP-HE2026-02-10
08059224167503PLUSLaboratory set Standard (with pin)192CPC-HE2026-02-10
08059224167510PLUSLaboratory set Extended (without pin)192CPS-HE2026-02-10
08059224167527OT EQUATORExtraction/insertion tool for caps488EIP-HE2026-02-10
08059224167534PLUSCap without pin yellow (0,6kg / 1,32lbs)140CPG-HE2026-02-10
08059224167541PLUSCap without pin black (lab use)140CPN-HE2026-02-10
08059224167558PLUSCap without pin pink (0,8kg / 1,76lbs)140CPP-HE2026-02-10
08059224167565PLUSCap with pin yellow (0,7kg / 1,54lbs)140CPPG-HE2026-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
D990TC10PKOA0Temporary Cylinder 10PK, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990TC1PKOA0Temporary Cylinder 1PK, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19