SPHERO BLOCK NORMO 002AOA1R

GUDID 08059224036137

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.

RHEIN 83 SRL

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed
Primary Device ID08059224036137
NIH Device Record Key7ec602e9-7973-496f-ac21-46c73e68261e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPHERO BLOCK NORMO
Version Model NumberS/BLOCK N ASTRA ACQUA ø3,5-4 h.1 TiN
Catalog Number002AOA1R
Company DUNS439240722
Company NameRHEIN 83 SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108059224036137 [Primary]
HIBCCD821002AOA1R0 [Previous]

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08059224036137]

Moist Heat or Steam Sterilization


[08059224036137]

Moist Heat or Steam Sterilization


[08059224036137]

Moist Heat or Steam Sterilization


[08059224036137]

Moist Heat or Steam Sterilization


[08059224036137]

Moist Heat or Steam Sterilization


[08059224036137]

Moist Heat or Steam Sterilization


[08059224036137]

Moist Heat or Steam Sterilization


[08059224036137]

Moist Heat or Steam Sterilization


[08059224036137]

Moist Heat or Steam Sterilization


[08059224036137]

Moist Heat or Steam Sterilization


[08059224036137]

Moist Heat or Steam Sterilization


[08059224036137]

Moist Heat or Steam Sterilization


[08059224036137]

Moist Heat or Steam Sterilization


[08059224036137]

Moist Heat or Steam Sterilization


[08059224036137]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-22
Device Publish Date2021-07-14

On-Brand Devices [SPHERO BLOCK NORMO]

D821002XIV3R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002XIV2R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002TRE51R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002STN342R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002SPL45R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002SPL44R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002SPL42R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002SPL41R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002SMD4R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002SMD3R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002SMD1R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002RPS51R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002RPS505R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002RPS434R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002RPS433R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002RPS432R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002RPS431R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002RPS4305R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002RPS354R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002RPS353R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002RPS352R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002PRI54R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002PRI53R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002PRI52R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002PRI51R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002PRI414R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002PRI413R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002PRI412R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002PRI411R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002PRI353R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002PRI351R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002NEO3R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002NEO2R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002NEO1R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002NAC395R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002NAC394R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002NAC393R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002NAC392R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002NAC391R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002NAC357R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002NAC356R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002NAC354R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002NAC353R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002NAC352R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002NAC351R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002NAC33R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002NAC32R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002NAC31R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002LEG35R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a
D821002LEG33R0Titanium abutment designed as an endosseous dental implant retentive component used to retain a

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.