STELA 8640001

GUDID DO3686400011

SDI LIMITED

Dental composite resin

• Primary Device ID: DO3686400011
• NIH Device Record Key: 61c9be7d-9b9e-4147-bff8-8fe820f81b85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STELA
• Version Model Number: STELA AUTOMIX 1 SYR REFILL
• Catalog Number: 8640001
• Company DUNS: 753221852
• Company Name: SDI LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	DO3686400011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222581

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2024-02-16
• Device Publish Date: 2024-02-08

On-Brand Devices [STELA]

• DO3686400061: STELA PRIMER REFILL 5ML BT
• DO3686400041: STELA CAPSULES INTRO KIT
• DO3686400031: STELA CAPSULE REFILL 50 CAP
• DO3686400021: STELA AUTOMIX INTRO KIT
• DO3686400011: STELA AUTOMIX 1 SYR REFILL
• 09336472002411: STELA PRIMER REFILL 5ML BT
• 09336472002398: STELA CAPSULES INTRO KIT
• 09336472002381: STELA CAPSULE REFILL 50 CAP
• 09336472002374: STELA AUTOMIX INTRO KIT
• 09336472002367: STELA AUTOMIX 1 SYR REFILL