NexxZr Plus Multi 2.0 A3.5 W98-14mm

GUDID 00842271158222

SAGEMAX BIOCERAMICS, INC

Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic
Primary Device ID00842271158222
NIH Device Record Key2e36309d-4dcc-4fe5-8f75-6b6345856cdc
Commercial Distribution StatusIn Commercial Distribution
Brand NameNexxZr Plus Multi 2.0 A3.5 W98-14mm
Version Model Number760343
Company DUNS002265727
Company NameSAGEMAX BIOCERAMICS, INC
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 Usefalse
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
GS100842271158222 [Primary]

FDA Product Code

EIHPowder, Porcelain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-27
Device Publish Date2024-03-19

Devices Manufactured by SAGEMAX BIOCERAMICS, INC

00842271158666 - NexxZr Plus Multi 2.0 B3 W98-20mm2024-03-28
00842271158673 - NexxZr Plus Multi 2.0 B4 W98-20mm2024-03-28
00842271158680 - NexxZr Plus Multi 2.0 C1 W98-20mm2024-03-28
00842271158697 - NexxZr Plus Multi 2.0 C2 W98-20mm2024-03-28
00842271158703 - NexxZr Plus Multi 2.0 C3 W98-20mm2024-03-28
00842271158710 - NexxZr Plus Multi 2.0 C4 W98-20mm2024-03-28
00842271158727 - NexxZr Plus Multi 2.0 D2 W98-20mm2024-03-28
00842271158734 - NexxZr Plus Multi 2.0 D3 W98-20mm2024-03-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.