FDA.reportPublic FDA data

SPHERO BLOCK NORMO

Primary DI
D821002NAC33R0
Brand
SPHERO BLOCK NORMO
Company
RHEIN 83 SRL
Model
S/BLOCK N NOBEL ACTIVE NP ø S/BLOCK N NOBEL ACTIVE
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
2018-07-02
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
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D821002NAC33R0PrimaryHIBCC0

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
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
00810126046871ET III Fixture SA Regular No MountHIOSSEN, INC.DZE2026-07-14
07290112780010Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780522Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780645Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780652Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781215Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781222Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781246Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781260Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781284Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781710Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781727Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290114710565AbutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
08800070203415ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203422ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203439ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203446ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228975ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228982ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228999ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229002ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229019ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229026ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229033ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229040ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229057ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229064ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070229071ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26