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 - D972AMC2125UMNAT25EKF1 Catalog Number :

Device Description : 21X25 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 - D972AMC2125UMNITI10EPL1 Catalog Number :

Device Description : 21X25 UPR NAT MEDIUM (TRUFORM) NITI 10/Env

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

ARCHWIRE - D972AMC2125UOF3SS14 Catalog Number :

Device Description : 21X25 Upr Orthoform III ST S/S

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Straight Wire - D972AMC2125UOF3SS4T1 Catalog Number :

Device Description : 21X25 Upr Orthoform III ST S/S

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Straight Wire - D972AMC215COAX1410TDZ1 Catalog Number :

Device Description : 0215 Staight and Cut 14" Coax S/S ST 10/Tube

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Straight Wire - D972AMC215COAX30JJ1 Catalog Number :

Device Description : 0215 COAX 30'/#3BOBBIN

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Straight Wire - D972AMC28SC14ST25T7P1 Catalog Number :

Device Description : 028 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

Straight Wire - D972AMC28SSBCLASP100B91 Catalog Number :

Device Description : 028 S/S BALL CLASP .050" Ball Dia/1.560" Length 100/Bag

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Straight Wire - D972AMC30SC14ST25TZB1 Catalog Number :

Device Description : 030 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

Straight Wire - D972AMC30SC14ST98 Catalog Number :

Device Description : 030 S&C 14" S/S ST

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

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