ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC

Address:7851 Airpark Rd Ste 202,GAITHERSBURG,MD,20879,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

Epilator, High Frequency, Tweezer-Type (KCX) (5) Scaler, Periodontic (EMN) (3) Plier, Orthodontic (JEX) (2)

Premarket Exempt

No Yes

Clear

DENALI - 00810042120211 Catalog Number :

Device Description : Plain Tip Mosquito Hemostat - Straight

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : JEX

Prescription Use : No

Device Count : 1

DENALI - 00810042120228 Catalog Number :

Device Description : Elastics Mosquito - Straight

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : JEX

Prescription Use : No

Device Count : 1

DENALI - 00810042120235 Catalog Number :

Device Description : Bracket Tweezer - Standard Small

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : KCX

Prescription Use : No

Device Count : 1

DENALI - 00810042120242 Catalog Number :

Device Description : Bracket Tweezer - Standard Large

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : KCX

Prescription Use : No

Device Count : 1

DENALI - 00810042120259 Catalog Number :

Device Description : Keat Buccal Tube Tweezer

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : KCX

Prescription Use : No

Device Count : 1

DENALI - 00810042120266 Catalog Number :

Device Description : Reverse Action Keat Buccal Tube Tweezer

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : KCX

Prescription Use : No

Device Count : 1

DENALI - 00810042120273 Catalog Number :

Device Description : Curved Bracket Tweezer

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : KCX

Prescription Use : No

Device Count : 1

DENALI - 00810042120297 Catalog Number :

Device Description : Elastic Module Applicator

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : EMN

Prescription Use : No

Device Count : 1

DENALI - 00810042120303 Catalog Number :

Device Description : Band Pusher & Scaler

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : EMN

Prescription Use : No

Device Count : 1

DENALI - 00810042120310 Catalog Number :

Device Description : Band Pusher & Director

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : EMN

Prescription Use : No

Device Count : 1

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