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) (3) Scaler, Periodontic (EMN) (3) Retractor, All Types (EIG) (2) Gauge, Depth, Instrument, Dental (EIL) (1) Plier, Orthodontic (JEX) (1)

Premarket Exempt

No Yes

Clear

DENALI - 00810042120426 Catalog Number :

Device Description : Dontrix Force Gauge

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : EIL

Prescription Use : No

Device Count : 1

DENALI - 00810042120433 Catalog Number :

Device Description : Crown & Band Crimping Plier

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : JEX

Prescription Use : No

Device Count : 1

DENALI - 00810042120440 Catalog Number :

Device Description : Stainless Steel Retractor - Double Ended

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : EIG

Prescription Use : No

Device Count : 1

DENALI - 00810042120457 Catalog Number :

Device Description : Stainless Steel Retractor - Single Ended

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : EIG

Prescription Use : No

Device Count : 1

DENALI - 00810042120464 Catalog Number :

Device Description : College Pliers

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : KCX

Prescription Use : No

Device Count : 1

DENALI - 00810042120471 Catalog Number :

Device Description : College Pliers with Lock

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : KCX

Prescription Use : No

Device Count : 1

DENALI - 00810042120488 Catalog Number :

Device Description : Perry Tweezer - Curved Tip

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : KCX

Prescription Use : No

Device Count : 1

DENALI - 00810042120495 Catalog Number :

Device Description : Cone Socket Mirrors #4 - 10/pk

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : EMN

Prescription Use : No

Device Count : 1

DENALI - 00810042120501 Catalog Number :

Device Description : Cone Socket Mirrors #4 - with round handle

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : EMN

Prescription Use : No

Device Count : 1

DENALI - 00810042120518 Catalog Number :

Device Description : Cone Socket Mirror #4 - with octagonal handle

Device Class : 1

Duns Number: 077801124

Premarket Exempt : Yes

Product Code : EMN

Prescription Use : No

Device Count : 1

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