Aidite 3D Printing Model Resin
- Primary DI
- 06976087534759
- Brand
- Aidite 3D Printing Model Resin
- Company
- Aidite (Qinhuangdao) Technology Co., Ltd.
- Model
- APMR01
- Device description
- For making dental models
- Published
- 2023-10-14
- 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
- true
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 |
|---|
| 06976087534759 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 06976087534759 | 06976087534759 | 6976087534759 |
GMDN Terms
| Term | Definition |
|---|
| Custom-made dental anatomy model | A dental device made of gypsum (e.g., plaster, dental stone) intended to be used as a replica (model) of a specific patient’s teeth and gums, to assist with a dental treatment-related procedure (e.g., production of a dental restoration, design of a teeth whitening tray). It is created via casting (i.e., taking the impression of the patient’s teeth/gums, pouring plaster into the impression, and then removing the impression). This is a single-use device. |
Contacts
| Phone | Email |
|---|
| +03358357346 | yangmeng@aidite.com |
Regulatory Flags
- DUNS number
- 529607549
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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