Obtura Spartan 824-706

GUDID 10843471150051

Obtura MaxPack Main Device

Young Innovations, Inc.

Endodontic obturation system Endodontic obturation system Endodontic obturation system Endodontic obturation system Endodontic obturation system Endodontic obturation system Endodontic obturation system Endodontic obturation system Endodontic obturation system Endodontic obturation system Endodontic obturation system Endodontic obturation system Endodontic obturation system

• Primary Device ID: 10843471150051
• NIH Device Record Key: 8c7e1cc7-01ac-4df6-9067-cf285356e884
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Obtura Spartan
• Version Model Number: 824-706
• Catalog Number: 824-706
• Company DUNS: 004193103
• Company Name: Young Innovations, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (800) 558-6684
• Email: support@youngspecialties.com
• Phone: +1 (800) 558-6684
• Email: support@youngspecialties.com
• Phone: +1 (800) 558-6684
• Email: support@youngspecialties.com
• Phone: +1 (800) 558-6684
• Email: support@youngspecialties.com
• Phone: +1 (800) 558-6684
• Email: support@youngspecialties.com
• Phone: +1 (800) 558-6684
• Email: support@youngspecialties.com
• Phone: +1 (800) 558-6684
• Email: support@youngspecialties.com
• Phone: +1 (800) 558-6684
• Email: support@youngspecialties.com
• Phone: +1 (800) 558-6684
• Email: support@youngspecialties.com
• Phone: +1 (800) 558-6684
• Email: support@youngspecialties.com
• Phone: +1 (800) 558-6684
• Email: support@youngspecialties.com
• Phone: +1 (800) 558-6684
• Email: support@youngspecialties.com
• Phone: +1 (800) 558-6684
• Email: support@youngspecialties.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843471150054 [Primary]
GS1	10843471150051 [Package]; Contains: 00843471150054; Package: PACKAGE [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060347

FDA Product Code

• EKR: PLUGGER, ROOT CANAL, ENDODONTIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-14
• Device Publish Date: 2022-10-06

On-Brand Devices [Obtura Spartan]

• 10843471152796: Obtura III Max Module Kit
• 10843471150051: Obtura MaxPack Main Device
• 10843471137472: Obtura Spartan MaxPack System
• 10843471137397: S-Kondenser
• 00843471137383: S-Kondenser, 60-120 (Blue)
• 00843471137376: S-Kondenser, 50-100 (Yellow)
• 00843471137369: S-Kondenser, 40-80 (Black)
• 10843471137342: KMIRROR, 21mm rhodium
• 00843471136546: Obtura Spartan Plugger 60/.12 Taper
• 00843471136539: Obtura Spartan Plugger 55/.10 Taper
• 00843471136522: Obtura Spartan Plugger 55/.08 Taper
• 00843471136515: Obtura Spartan Plugger 55/.06 Taper
• 00843471136508: Obtura Spartan Plugger 45/.04 Taper
• 00843471136492: Obtura Spartan Plugger 40/.04 Taper
• 00843471136485: Obtura Spartan Plugger 35/.04 Taper
• 00843471136478: Buchanan Plugger xtra Fine .04
• 00843471136461: Buchanan Plugger, Med-Lg .12
• 00843471136454: Buchanan Plugger, Medium .10
• 00843471136447: Buchanan Plugger, Fine-Med .08
• 00843471136430: Buchanan Plugger, Fine .06
• 00843471101001: EMS Threaded Tip BUC-3E
• 00843471100998: EMS Threaded Tip BUC-2E
• 00843471100981: EMS Threaded Tip BUC-1E
• 00843471100967: EMS Threaded Tip KiS-6E
• 00843471100950: EMS Threaded Tip KiS-5E
• 00843471100943: EMS Threaded Tip KiS-4E
• 00843471100936: EMS Threaded Tip KiS-3E
• 00843471100929: EMS Threaded Tip KiS-2E
• 00843471100875: EMS Threaded Tip KiS-1E
• 00843471100844: EMS Threaded Tip CPR-8E
• 00843471100837: EMS Threaded Tip CPR-7E
• 00843471100820: EMS Threaded Tip CPR-6E
• 00843471100813: EMS Threaded Tip CPR-5E
• 00843471100806: EMS Threaded Tip CPR-4E
• 00843471100790: EMS Threaded Tip CPR-3E
• 00843471100783: EMS Threaded Tip CPR-1E
• 00843471100776: EMS Threaded Tip CPR-2E
• 00843471100660: Tip CPR-8 Bronze 27mm
• 00843471100653: Tip CPR-7 Blue 24mm
• 00843471100646: Tip CPR-6 Violet 20mm
• 00843471100639: Tip CPR-5D Diamond
• 00843471100622: Tip CPR-4D Diamond
• 00843471100615: Tip CPR-3D Diamond
• 00843471100608: Tip CPR-2D Diamond
• 00843471100592: Tip CPR-1
• 00843471100585: Tip BUC-3A
• 00843471100578: Tip BUC-1A
• 00843471100561: Tip BUC-2A
• 00843471100547: Tip BUC-3
• 00843471100530: Tip BUC-2