Aurora™ D548

GUDID 10810000520135

Aurora™ S3 Tacking Lens D546 (Pkg. of 5 pcs.)

PARKELL, INC.

Dental/surgical polymerization lamp

• Primary Device ID: 10810000520135
• NIH Device Record Key: 7ab74943-d0b1-4777-abcf-71fb3744668f
• Commercial Distribution Discontinuation: 2019-07-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Aurora™
• Version Model Number: D548
• Catalog Number: D548
• Company DUNS: 009900424
• Company Name: PARKELL, INC.
• Device Count: 5
• DM Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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: 6312491134
• Email: customerservice@parkell.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810000520138 [Unit of Use]
GS1	10810000520135 [Primary]

FDA Product Code

• EBZ: Activator, Ultraviolet, For Polymerization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-18
• Device Publish Date: 2018-11-16

On-Brand Devices [Aurora™]

• 00810000520145: Aurora™ S3 Replacement Battery D546
• 00810000520114: Battery for Aurora™ Curing Light D540
• 00810000520091: 110 Volt Battery Charger for Aurora™ D540
• M595D6750: Aluminum Oxide (50micron) 5 Lbs.
• M595D5490: Aurora™ S3 Replacement Battery D546
• M595D5481: Aurora™ S3 Tacking Lens D546 (Pkg. of 5 pcs.)
• M595D5471: Aurora™ S3 Curing Lens D546 (Pkg. of 10 pcs.)
• M595D5440: Battery for Aurora™ Curing Light D540
• M595D5431: Tacking Lens for Aurora™ D540 (Pkg. of 5 pcs.)
• M595D5421100: 110 Volt Battery Charger for Aurora™ D540
• 10810000520135: Aurora™ S3 Tacking Lens D546 (Pkg. of 5 pcs.)
• 10810000520104: Tacking Lens for Aurora™ D540 (Pkg. of 5 pcs.)
• 10810000527523: Aurora™ Barrier Sleeves (Pkg. of 1000 pcs.)
• 10810000520128: Aurora™ S3 Curing Lens D546 (Pkg. of 10 pcs.)
• 10810000520081: Curing Lens for Aurora™ D540 (Pkg. of 10 pcs.)