SHOFU DISK
- Primary DI
- E2352186S0
- Brand
- SHOFU DISK
- Company
- SHOFU DENTAL CORPORATION
- Model
- 2186S
- Catalog number
- 2186S
- Device description
- SHOFU DISK HC A1-HT T14S
- Published
- 2016-09-26
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| EBF | Material, Tooth Shade, Resin |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EBF | Material, Tooth Shade, Resin | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| E2352186S0 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental CAD/CAM system, chairside | An assembly of software-based devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (specifically prescribed to each patient's needs) dental restorations produced chairside during dental or orthodontic treatment. It typically includes, or is used in conjunction with, three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase, software for record collection, treatment planning, simulation and device production, and robotic capabilities for the production of the actual devices to be fitted to the patient. |
Regulatory Flags
- DUNS number
- 054618202
- 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
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00815967025856 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-24 |
| 00815967025863 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-24 |
| 00815967025870 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-24 |
| 00815967021438 | OptiComp | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967021797 | OptiComp | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967027447 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028161 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028178 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028185 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028192 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028208 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028215 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028222 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028239 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028246 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028253 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028260 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028277 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028284 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028291 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028307 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028314 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028321 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028338 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028345 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028352 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028369 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028376 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028383 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
| 00815967028390 | Rodin | Pac-Dent, Inc. | EBF | 2026-03-23 |
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