STELA 8640001

GUDID DO3686400011

SDI LIMITED

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin 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