ECOTEC MANUFACTURING, INC.

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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

Sprays, Synthetic, Smear (IFI) (2) Tester, Pulp (EAT) (2)

Premarket Exempt

Yes

Clear

COLD AS ICE - 00852509006027 Catalog Number :

Device Description : Endo Freeze Spray

Device Class :

Duns Number: 121411859

Premarket Exempt : Yes

Product Code : IFI

Prescription Use : No

Device Count : 1

ENDODONTIC SPRAY - 00860177000629 Catalog Number :

Device Description : ENDODONTIC SPRAY PULP VITALITY REFRIGERANT

Device Class :

Duns Number: 121411859

Premarket Exempt : Yes

Product Code : EAT

Prescription Use : No

Device Count : 1

Max Pro Medical Freeze Spray - 00860177000636 Catalog Number :

Device Description : Medical Freeze Spray

Device Class : 1

Duns Number: 121411859

Premarket Exempt : Yes

Product Code : IFI

Prescription Use : No

Device Count : 1

Endodontic Specialists of Northern Colorado Endo Ice - 00860177000643 Catalog Number :

Device Description : Endo Freeze Spray

Device Class : 2

Duns Number: 121411859

Premarket Exempt : Yes

Product Code : EAT

Prescription Use : No

Device Count : 1

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