Obtura Spartan 824-706

GUDID 10843471150051

Obtura MaxPack Main Device

Young Innovations, Inc.

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