ULTRAMAT 2 5546045

GUDID 09336472005474

ULTRAMAT 2MV US

SDI LIMITED

Dental amalgam mixer
Primary Device ID09336472005474
NIH Device Record Keyf6a45b40-0634-4bfc-a848-aebcac5d5d05
Commercial Distribution Discontinuation2026-02-16
Commercial Distribution StatusNot in Commercial Distribution
Brand NameULTRAMAT 2
Version Model Number5546045
Catalog Number5546045
Company DUNS753221852
Company NameSDI LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109336472005474 [Primary]

FDA Product Code

EFDAmalgamator, Dental, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-24
Device Publish Date2026-02-16

Devices Manufactured by SDI LIMITED

29336472004747 - BENCO ADMIX2026-02-25 BENCO ADMIX 2SP REG 50
29336472004754 - BENCO SPHERICAL2026-02-25 BENCO SPHR 2SP REG 50
29336472004860 - BENCO ADMIX2026-02-25 BENCO ADMIX 2SP REG 500
29336472004877 - BENCO SPHERICAL2026-02-25 BENCO SPHR 2SP REG 500
D662070830158 - PD ADMIX2026-02-25 PD ADMIX 2SP FAST 500
D662070830166 - PD ADMIX2026-02-25 PD ADMIX 2SP REG 500
D662070830273 - PD ADMIX2026-02-25 PD ADMIX 2SP FAST 50
D662070830281 - PD ADMIX2026-02-25 PD ADMIX 2SP REG 50

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