SPHERO BLOCK MICRO 003AOA5R

GUDID 08059224039954

The OT Equator is designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The OT Equator is screwed into an endosseous implant in the mandible or maxilla.

RHEIN 83 SRL

Dental implant suprastructure, permanent, preformed
Primary Device ID08059224039954
NIH Device Record Key34099e11-b211-4283-850a-c1a6b1081250
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPHERO BLOCK MICRO
Version Model NumberSET S.BLOCK M. ASTRA ACQUA ø 3.5-4 h5
Catalog Number003AOA5R
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 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
GS108059224039954 [Primary]

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08059224039954]

Moist Heat or Steam Sterilization


[08059224039954]

Moist Heat or Steam Sterilization


[08059224039954]

Moist Heat or Steam Sterilization


[08059224039954]

Moist Heat or Steam Sterilization


[08059224039954]

Moist Heat or Steam Sterilization


[08059224039954]

Moist Heat or Steam Sterilization


[08059224039954]

Moist Heat or Steam Sterilization


[08059224039954]

Moist Heat or Steam Sterilization


[08059224039954]

Moist Heat or Steam Sterilization


[08059224039954]

Moist Heat or Steam Sterilization


[08059224039954]

Moist Heat or Steam Sterilization


[08059224039954]

Moist Heat or Steam Sterilization


[08059224039954]

Moist Heat or Steam Sterilization


[08059224039954]

Moist Heat or Steam Sterilization


[08059224039954]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-11
Device Publish Date2025-07-03

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