FREEPRINT crown D3 500g
- Primary DI
- EDET043791
- Brand
- FREEPRINT crown D3 500g
- Company
- DETAX GmbH & Co. KG
- Model
- 04379
- Published
- 2022-09-29
- 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 |
|---|
| EBG | Crown And Bridge, Temporary, Resin |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EBG | Crown And Bridge, Temporary, Resin | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| EDET043791 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental appliance fabrication material, resin | A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated. |
Regulatory Flags
- DUNS number
- 317099257
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- 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
- false
- Sterilization required before use
- false
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| EDET041651 | medicalprint shell red opaque 1000g | 04165 | | 2022-10-26 |
| EDET042301 | detax softwear 2.0 clear 40 shore 8x 50 ml | 04230 | | 2022-10-26 |
| EDET042381 | detax softwear 2.0 blue 60 shore 2 x 50 ml | 04238 | | 2022-10-26 |
| EDET042461 | luxaprint flex UV 500 g | 04246 | | 2022-10-26 |
| EDET027231 | aquaplus putty blue 2 x 250 ml | 02723 | | 2022-10-25 |
| EDET027241 | aquaplus putty red 2 x 250 ml | 02724 | | 2022-10-25 |
| EDET029411 | protect mold neon pink 2 x 100ml | 02941 | | 2022-10-25 |
| EDET029461 | protect mold neon green 2 x 100ml | 02946 | | 2022-10-25 |
| EDET029471 | protect mold neon green 2 x 100ml | 02947 | | 2022-10-25 |
| EDET029481 | protect mold neon orange 2 x 100ml | 02948 | | 2022-10-25 |
| EDET029491 | super coat 100ml | 02949 | | 2022-10-25 |
| EDET029501 | super coat 300ml | 02950 | | 2022-10-25 |
| EDET029911 | earflex 40 sh rainbow 8 x 50 ml | 02991 | | 2022-10-25 |
| EDET030121 | express coat 100ml | 03012 | | 2022-10-25 |
| EDET030141 | dip coat 100ml | 03014 | | 2022-10-25 |
| EDET030151 | dip coat 250ml | 03015 | | 2022-10-25 |
| EDET031921 | earflex 40 sh clear 8 x 50 ml | 03192 | | 2022-10-25 |
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