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 - 00816168020619 Catalog Number : 941-106

Device Description : Tip PST-6

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Obtura Spartan - 00816168020626 Catalog Number : 941-107

Device Description : Tip PST-7

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Obtura Spartan - 00816168020633 Catalog Number : 941-108

Device Description : Tip PST-8

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Obtura Spartan - 00816168020640 Catalog Number : 941-109

Device Description : Tip Set of 8 PST 1-8Contains:941-101 Tip PST-1 DI# 00816168020565941-102 Tip PST Tip Set of 8 PST 1-8Contains:941-101 Tip PST-1 DI# 00816168020565941-102 Tip PST-2 DI# 00816168020572941-103 Tip PST-3 DI# 00816168020589941-104 Tip PST-4 DI# 00816168020596941-105 Tip PST-5 DI# 00816168020602941-106 Tip PST-6 DI# 00816168020619941-107 Tip PST-7 DI# 00816168020626941-108 Tip PST-8 DI# 00816168020633

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Obtura Spartan - 00816168020657 Catalog Number : 952-614

Device Description : Tip KiS 1D4 Diamond

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Obtura Spartan - 00816168020664 Catalog Number : 932-017

Device Description : EMS Threaded Tip Set KiS 1-6EContains:932-011 Tip KiS-1E DI# 00816168020428932-0 EMS Threaded Tip Set KiS 1-6EContains:932-011 Tip KiS-1E DI# 00816168020428932-012 Tip KiS-2E DI# 00816168020435932-013 Tip KiS-3E DI# 00816168020442932-014 Tip KiS-4E DI# 00816168020459932-015 Tip KiS-5E DI# 00816168020466932-016 Tip KiS-6E DI# 00816168020473

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Obtura Spartan - 00816168020671 Catalog Number : 948-201

Device Description : Spartan Wave Handpiece

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Obtura Spartan - 00816168020688 Catalog Number : 948-100

Device Description : Spartan Wave Ultrasonic Unit

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Obtura Spartan - 00816168020695 Catalog Number : 952-615

Device Description : Tip KiS 5D2

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

Obtura Spartan - 00816168020701 Catalog Number : 930-031

Device Description : Tip SL-1A

Device Class : 2

Duns Number: 078371330

Premarket Exempt : No

Product Code : ELC

Prescription Use : No

Device Count : 1

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