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) (10)

Premarket Exempt

Clear

Obtura Spartan - 00816168020312 Catalog Number : 930-043

Device Description : Tip BUC-3

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Obtura Spartan - 00816168020329 Catalog Number : 932-001

Device Description : EMS Threaded Tip CPR-1E

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Obtura Spartan - 00816168020336 Catalog Number : 932-002

Device Description : EMS Threaded Tip CPR-2E

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Obtura Spartan - 00816168020343 Catalog Number : 932-003

Device Description : EMS Threaded Tip CPR-3E

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Obtura Spartan - 00816168020350 Catalog Number : 932-004

Device Description : EMS Threaded Tip CPR-4E

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Obtura Spartan - 00816168020367 Catalog Number : 932-005

Device Description : EMS Threaded Tip CPR-5E

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Obtura Spartan - 00816168020374 Catalog Number : 932-006

Device Description : EMS Threaded Tip CPR-6E

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Obtura Spartan - 00816168020381 Catalog Number : 932-007

Device Description : EMS Threaded Tip CPR-7E

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Obtura Spartan - 00816168020398 Catalog Number : 932-008

Device Description : EMS Threaded Tip CPR-8E

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Obtura Spartan - 00816168020404 Catalog Number : 932-009

Device Description : EMS Threaded Tip Set CPR 1-5EContains:932-001 Tip CPR-1E DI# 00816168020329932-0 EMS Threaded Tip Set CPR 1-5EContains:932-001 Tip CPR-1E DI# 00816168020329932-002 Tip CPR-2E DI# 00816168020336932-003 Tip CPR-3E DI# 00816168020343932-004 Tip CPR-4E DI# 00816168020350932-005 Tip CPR-5E DI# 00816168020367

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

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