| Primary Device ID | 04719883751355 |
| NIH Device Record Key | 70f6d4f7-069d-4fed-aaf3-0c69cf91f26a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | APOZA |
| Version Model Number | LIGHT GUIDE-13mm |
| Company DUNS | 656816337 |
| Company Name | APOZA ENTERPRISE CO., LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719883751355 [Primary] |
| EAY | Light, Fiber Optic, Dental |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04719883751355]
Moist Heat or Steam Sterilization
[04719883751355]
Moist Heat or Steam Sterilization
[04719883751355]
Moist Heat or Steam Sterilization
[04719883751355]
Moist Heat or Steam Sterilization
[04719883751355]
Moist Heat or Steam Sterilization
[04719883751355]
Moist Heat or Steam Sterilization
[04719883751355]
Moist Heat or Steam Sterilization
[04719883751355]
Moist Heat or Steam Sterilization
[04719883751355]
Moist Heat or Steam Sterilization
[04719883751355]
Moist Heat or Steam Sterilization
[04719883751355]
Moist Heat or Steam Sterilization
[04719883751355]
Moist Heat or Steam Sterilization
[04719883751355]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-29 |
| Device Publish Date | 2023-06-21 |
| 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. |