Premium Plus
- Primary DI
- D12518N4012
- Brand
- Premium Plus
- Company
- Premium Plus (Dongguan) Limited
- Model
- 18-N401
- Device description
- Dental Impression Trays
- Published
- 2026-06-09
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes#
Code, Name table| Code | Name |
|---|
| EHY | Tray, Impression, Preformed |
Product Code Classifications#
Code, Device, Specialty table| Code | Device | Specialty | Class |
|---|
| EHY | Tray, Impression, Preformed | Dental | 1 |
Identifiers And Packaging#
Identifier, Type, Agency table| Identifier | Type | Agency | Package quantity | Status |
|---|
| D12518N4016 | Package | HIBCC | 10 | In Commercial Distribution |
| D12518N4018 | Package | HIBCC | 2 | In Commercial Distribution |
| D12518N4012 | Primary | HIBCC | 0 | |
| D12518N4010 | Unit of Use | HIBCC | 0 | |
Regulatory Flags#
- DUNS number
- 541637603
- Device count
- 36
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company#
Other Devices Sharing Product Codes#
Primary DI, Brand, Company table| Primary DI | Brand | Company | Product code | Published |
|---|
| 00840456218907 | JMU | JMU DENTAL, INC | EHY | 2026-07-09 |
| D12518N4022 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D12518N4032 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D12518N4042 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D12518N4052 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D12518S4012 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D12518S4022 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D12518S4032 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D12518T4012 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D12518T4022 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D12518T4032 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D1254334 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D1254344 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D1254354 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D1254364 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D1254374 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D1254384 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D1254394 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D1254404 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D1254514 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D1254524 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D1254534 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D1254544 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D1254554 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D1254564 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D1254574 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D1254584 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D1254594 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D1254604 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |
| D125N4012 | Premium Plus | Premium Plus (Dongguan) Limited | EHY | 2026-06-09 |