FDA.reportPublic FDA data

SPHERO FLEX

Primary DI
D821109BLR3R0
Brand
SPHERO FLEX
Company
RHEIN 83 SRL
Model
S/FLEX BONE LEVEL ø 4,1-4,8 RC h.3 TiN
Catalog number
109BLR3R
Device description
Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.
Published
2020-12-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D821109BLR3R0PrimaryHIBCC0

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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

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