Acme Monaco Corporation

Address:75 Winchell Rd,NEW BRITAIN,CT,06052,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) (9)

Premarket Exempt

Yes

Clear

Straight Wire - D972AMC32SC14ST25T38 Catalog Number :

Device Description : 032 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 - D972AMC32SS063BCLP100T6 Catalog Number :

Device Description : 032 S/S BALL CLASP .063" 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 - D972AMC36SC14ST25T6U1 Catalog Number :

Device Description : 036 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 - D972AMC36SS075BCLP10021 Catalog Number :

Device Description : 036 S/S BALL CLASP .075" 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 - D972AMC40SC14ST25T2D1 Catalog Number :

Device Description : 040 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

Ligature - D972AMC9LIG9 Catalog Number :

Device Description : 009 LONG STD PREFORM LIGATURE

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : No

Device Count : 1000

Straight Wire - D972AMCFLX06ZA1 Catalog Number :

Device Description : Flattened Multistrand Wire cut to 6.00±.125" length.

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Straight Wire - D972AMCFLX60ZG1 Catalog Number :

Device Description : Flattened Multistrand Wire/Soft (60" on #3 Bobbin)

Device Class : 1

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Archwire - D972D972AMC14RCUL10E232 Catalog Number :

Device Description : 014 UPR R/C NITI 10/Env

Device Class :

Duns Number: 118370238

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 2

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