Premium Plus
- Primary DI
- D8384398
- Brand
- Premium Plus
- Company
- Premium Plus International Limited
- Model
- 439
- Device description
- IMPRESSION TRAYS
- Published
- 2019-12-31
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| EHY | Tray, Impression, Preformed |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EHY | Tray, Impression, Preformed | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D8384396 | Package | HIBCC | 20 | In Commercial Distribution |
| D8384398 | Package | HIBCC | 4 | In Commercial Distribution |
| D8384394 | Primary | HIBCC | 0 | |
| D8384390 | Unit of Use | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental impression tray, reusable | A horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 668367758
- Device count
- 5
- 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
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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