Acme Monaco Corporation

Acme Monaco Corporation

Address:1450 Central Drive,PRESQUE ISLE,ME,04769,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Wire, Orthodontic (DZC) (10)

Premarket Exempt

Yes

Clear

Straight Wire - D972AMC1030NTI153TL1 Catalog Number :

Device Description : 10X30 OPEN NITI SPRING 15"/ #3 BOBBIN

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Ligature - D972AMC10ANGLIG1000TS7 Catalog Number :

Device Description : 010 SHORT TWISTED LIGATURE 1,000/TUBE

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Ligature - D972AMC10LIGMV1 Catalog Number :

Device Description : 010 STD PREFORM LIGATURE

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Archwire - D972AMC10LNITI32 Catalog Number :

Device Description : 010 LWR NAT NITI

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Archwire - D972AMC10UNITI65 Catalog Number :

Device Description : 010 UPR NAT NITI

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Straight Wire - D972AMC10X30X365F1 Catalog Number :

Device Description : 10X30 OPEN S/S SPRING 36"/#3 BOBBIN

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Straight Wire - D972AMC1215FTH3 Catalog Number :

Device Description : 012 NITI WOUND 15'/#3 BOBBIN

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

LIGATURE - D972AMC12ASKOBYF1 Catalog Number :

Device Description : 012 FLAT TWISTED KOBY LIGATURE ALMOND

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Ligature - D972AMC12LKOBY6 Catalog Number :

Device Description : 012 LONG KOBY WELD LIGATURE

Device Class :

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 100

Archwire - D972AMC12LMNITI10E2 Catalog Number :

Device Description : 012 LWR NAT MEDIUM (TRUFORM) NITI 10/Env

Device Class :

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 10

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