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

ArchWire - D972AMC16RST25E4 Catalog Number :

Device Description : 016 UNIV S/S ST 25/ENV

Device Class :

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 25

Straight Length - D972AMC16SC14ST25T4W1 Catalog Number :

Device Description : 016 STRAIGHT AND CUT 14" S/S ST - 25/TUBE

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Straight Wire - D972AMC16SC14ST25T4W2 Catalog Number :

Device Description : 016 S&C 14" S/S ST 25/TUBE

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Archwire - D972AMC16UMNAT25E1 Catalog Number :

Device Description : 016 UPR NAT MEDIUM (TRUFORM) S/S ST - 25/ENV

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

ArchWire - D972AMC16UMNAT25EXK1 Catalog Number :

Device Description : 016 UPR NAT MEDIUM (TRUFORM) S/S ST 25/ENV

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Archwire - D972AMC16UMNITI10E2 Catalog Number :

Device Description : 016 UPR NAT MEDIUM (TRUFORM) NITI 10/Env

Device Class :

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 10

Archwire - D972AMC16UNITI8K1 Catalog Number :

Device Description : 016 UPR NAT NITI

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Archwire - D972AMC16UNMCUN3510E2 Catalog Number :

Device Description : 016 UPR NAT MEDIUM (TRUFORM) COPPER NITI 35° C 10/Env

Device Class :

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 10

Straight Wire - D972AMC172514ST10T6D1 Catalog Number :

Device Description : 17X25 S&C 14" S/S ST 10/TUBE

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Archwire - D972AMC1725LMNAT25EJR1 Catalog Number :

Device Description : 17X25 LWR NAT MEDIUM (TRUFORM) S/S ST- 25/ENV

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

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