Gc Orthodontics America Inc.

Address:3737 W. 127th Street,Alsip,IL,60803,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) (3)

Premarket Exempt

No Yes

Clear

Labial Bow - E53592012000571 Catalog Number : 92-0120-0057

Device Description : Labial Bow Standard 57mm

Device Class : 1

Duns Number: 063167128

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Labial Bow - E53592012000601 Catalog Number : 92-0120-0060

Device Description : Labial Bow Standard 60mm

Device Class : 1

Duns Number: 063167128

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

Labial Bow - E53592012000631 Catalog Number : 92-0120-0063

Device Description : Labial Bow Standard 63mm

Device Class : 1

Duns Number: 063167128

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

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