Aurora™ D548

GUDID M595D5481

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

PARKELL, INC.

Dental/surgical polymerization lamp

• Primary Device ID: M595D5481
• NIH Device Record Key: c373f11e-853f-4cc9-b2c8-ed821b827505
• Commercial Distribution Discontinuation: 2019-01-01
• 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: 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: 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
HIBCC	M595D5480 [Primary]
HIBCC	M595D5481 [Package]; Contains: M595D5480; Package: [5 Units]; Discontinued: 2019-01-01; Not in Commercial Distribution

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: 3
• Public Version Date: 2019-04-01
• Device Publish Date: 2016-09-24

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.)