OBTURA SPARTAN ENDODONTICS

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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

Scaler, Ultrasonic (ELC) (4)

Premarket Exempt

Clear

Obtura Spartan - 00816168020718 Catalog Number : 930-032

Device Description : Tip SL-2A

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Obtura Spartan - 00816168020725 Catalog Number : 930-033

Device Description : Tip SL-3A

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Obtura Spartan - 00816168020732 Catalog Number : 930-034

Device Description : Tip SL-4A

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Obtura Spartan - 00816168020749 Catalog Number : 932-023

Device Description : EMS Threaded Tip BUC-2AE

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

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