APOZA

GUDID 04719883751102

PROPHY APII is designed to clean extrinsic stains caused by tobacco, tea, coffee or food on tooth surfaces by using sodium bicarbonate. The air and water are supplied from dental unit.

APOZA ENTERPRISE CO., LTD.

Dental abrasive air jet system

• Primary Device ID: 04719883751102
• NIH Device Record Key: 005372e3-b552-4bf7-86e3-c92d7bfbd5b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APOZA
• Version Model Number: PROPHY APII
• 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	04719883751102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033198

FDA Product Code

• ELC: Scaler, Ultrasonic

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.