LITEX

GUDID 00858466005189

Curing Light

DENTAMERICA, INC.

Dental/surgical polymerization lamp

• Primary Device ID: 00858466005189
• NIH Device Record Key: 9a45f14e-982c-42de-ab6f-ab949caf2352
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LITEX
• Version Model Number: 695
• Company DUNS: 174436360
• Company Name: DENTAMERICA, INC.
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858466005189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955759

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: 2018-07-06
• Device Publish Date: 2016-10-05

On-Brand Devices [LITEX]

• 00858466005226: Curing Light
• 00858466005202: Curing Light
• 00858466005196: Curing Light
• 00858466005189: Curing Light
• 00858466005172: Curing Light