SPHERO BLOCK NORMO

GUDID D821002SPL42R0

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 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 IDD821002SPL42R0
NIH Device Record Key5edf72b6-de46-43aa-8c00-fd35d06d9d9b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPHERO BLOCK NORMO
Version Model NumberS/BLOCK NORMO SPLINE ø 3,75-4 h.2 TiN
Company DUNS439240722
Company NameRHEIN 83 SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
HIBCCD821002SPL42R0 [Primary]

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


[D821002SPL42R0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2018-07-02

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