APOZA

GUDID 04719883750853

1. LED CURING LIGHT: 5W. 2. There is a light meter on the charging stand

APOZA ENTERPRISE CO., LTD.

Dental/surgical polymerization lamp

• Primary Device ID: 04719883750853
• NIH Device Record Key: 7310c187-0d22-4462-9fa8-2a221c23596f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APOZA
• Version Model Number: D2000
• Company DUNS: 656816337
• Company Name: APOZA ENTERPRISE CO., LTD.
• 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: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719883750853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070373

FDA Product Code

• EBZ: Activator, Ultraviolet, For Polymerization

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: 2023-07-04
• Device Publish Date: 2023-06-26

On-Brand Devices [APOZA]

• 04719883751355: Light Guide 13mm. Accessories for APOZA LED Light Curing Unit
• 04719883751331: Light Guide 8mm. Accessories for APOZA LED Light Curing Unit
• 04719883751362: Light Guide 8mm to 2mm. Accessories for APOZA LED Light Curing Unit
• 04719883751348: Light Guide 11mm. Accessories for APOZA LED Light Curing Unit
• 04719883751324: 1. LED CURING LIGHT: 5W 2. There is no light meter on the charging stand
• 04719883751317: LED CURING LIGHT: 5W
• 04719883751300: GP obturation device is applied to professional dentistry, which cuts off and softens root canal
• 04719883751102: PROPHY APII is designed to clean extrinsic stains caused by tobacco, tea, coffee or food on toot
• 04719883750860: LED CURING LIGHT: 5W.
• 04719883750853: 1. LED CURING LIGHT: 5W. 2. There is a light meter on the charging stand
• 04719883750839: 1. LED CURING LIGHT: 7W 2. There is no light meter on the charging stand
• 04719883750822: Ozone DTA
• 04719883750624: LED CURING LIGHT
• 04719883750549: 1. LED CURING LIGHT: 7W 2. There is no light meter on the charging stand
• 04719883750464: 1. LED CURING LIGHT: 5W. 2. No light meter across stand
• 04719883750273: This unit is designed for in-office tooth bleaching. This unit must be operated by licensed dent
• 04719883750228: This unit is designed for in-office tooth bleaching. This unit must be operated by licensed dent
• 04719883751539: OzonyMED
• 04719883751522: CAM-I
• 04719883751515: LED CURING LIGHT: 5W.
• 04719883751508: LED CURING LIGHT: 3W.
• 04719883751492: LED CURING LIGHT: 5W.
• 04719883751478: LED CURING LIGHT: 5W.
• 04719883751454: LED CURING LIGHT: 5W.
• 04719883751447: LED CURING LIGHT: 5W.
• 04719883751423: CAM-II
• 04719883751416: Ultrasonic dental scaling, with Endo.
• 04719883751409: Ultrasonic dental scaling, without Endo.
• 04719883751393: Ultrasonic dental scaling, with Endo.
• 04719883751386: Ultrasonic dental scaling, without Endo.
• 04719883751379: LED CURING LIGHT: 5W.