| Primary Device ID | 06430035873388 |
| NIH Device Record Key | 4103d495-53ec-4338-a4d1-71a4375a1765 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OCCLUSAL 4C REFILL KIT |
| Version Model Number | 900802-DEX |
| Company DUNS | 459955188 |
| Company Name | PaloDEx Group Oy |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 06430035873388 [Primary] |
| PEM | Dental Barriers And Sleeves |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-31 |
| Device Publish Date | 2025-12-23 |
| 06430035873357 - COMFORT OCCLUSAL 4C ACCESSORY KIT | 2025-12-31 COMFORT OCCLUSAL 4C ACCESSORY KIT |
| 06430035873388 - OCCLUSAL 4C REFILL KIT | 2025-12-31OCCLUSAL 4C REFILL KIT |
| 06430035873388 - OCCLUSAL 4C REFILL KIT | 2025-12-31 OCCLUSAL 4C REFILL KIT |
| 06430035875191 - ORTHOPANTOMOGRAPH™ OP 3D | 2025-07-23 OP 3D EX CEPH UPGRADE KIT |
| 06430035875184 - ORTHOPANTOMOGRAPH™ OP 3D | 2025-03-19 ORTHOPANTOMOGRAPH™ OP 3D EX (PAN CEPH 3D) |
| 06430035872947 - OCCLUSAL 4C START-UP KIT | 2024-07-25 OCCLUSAL 4C START-UP KIT |
| 06430035875177 - ORTHOPANTOMOGRAPH™ OP 3D | 2024-05-14 ORTHOPANTOMOGRAPH™ OP 3D EX (PAN 3D) |
| 06430035875139 - ORTHOPANTOMOGRAPH™ OP 3D | 2024-03-22 OP 3D LX CEPH UPGRADE KIT |
| 06430035875092 - ORTHOPANTOMOGRAPH™ OP 3D | 2023-10-10 ORTHOPANTOMOGRAPH™ OP 3D LX (PAN 3D) |