STELA 8640006

GUDID DO3686400061

SDI LIMITED

Dental composite resin

• Primary Device ID: DO3686400061
• NIH Device Record Key: 1d8925b5-6bee-44b1-aac0-8c7acce76f58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STELA
• Version Model Number: STELA PRIMER REFILL 5ML BT
• Catalog Number: 8640006
• 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	DO3686400061 [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