FluoroPost™ Endodontic Fiber Posts
- Primary DI
- D00261I0331
- Brand
- FluoroPost™ Endodontic Fiber Posts
- Company
- DENTSPLY INTERNATIONAL INC.
- Model
- 61i033
- Catalog number
- 61i033
- Device description
- FluoroPost Endodontic Fiber Posts - Size #3 Blue
- Published
- 2019-04-02
- 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 |
|---|
| ELR | POST, ROOT CANAL |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ELR | Post, Root Canal | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D00261I0331 | Primary | HIBCC | 0 | |
| D00261I0330 | Unit of Use | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Root canal post, preformed | A prefabricated endodontic rod designed for insertion into the root canal of a patient to support and retain a crown prosthesis. It is typically a solid, cylindrical, metal (e.g., stainless steel, gold alloy) piece with a proximal end appropriate to support the crown on top; it is, however, available in a variety of shapes, dimensions, and materials (e.g., ceramics, fibre-reinforced polymers). In addition, it is available in a variety of types (e.g., non-threaded, pre-threaded, or self-tapping; straight or tapered). This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Keep away from sunlight. Keep dry. |
Regulatory Flags
- DUNS number
- 083235549
- 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
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|
| D0013010121 | Ceramco® 3 | Powder Opaque i2/i4 | 301012 | 2016-09-21 |
| D0013010211 | Ceramco® 3 | Powder Opaque D2 | 301021 | 2016-09-21 |
| D0013010311 | Ceramco® 3 | Powder Opaque Modifier Yellow | 301031 | 2016-09-21 |
| D0013010321 | Ceramco® 3 | Powder Opaque Modifier Sienna | 301032 | 2016-09-21 |
| D0013010361 | Ceramco® 3 | Powder Opaque Modifier Pink | 301036 | 2016-09-21 |
| D0013010371 | Ceramco® 3 | Powder Opaque Modifier Ochre | 301037 | 2016-09-21 |
| D0013010481 | Ceramco® 3 | Paste Opaque A3.5 | 301048 | 2016-09-21 |
| D0013010591 | Ceramco® 3 | Paste Opaque C2 | 301059 | 2016-09-21 |
| D0013010701 | Ceramco® 3 | Paste Opaque Modifiers White | 301070 | 2016-09-21 |
| D0013011031 | Ceramco® 3 | Opaceous Dentin i1 | 301103 | 2016-09-21 |
| D0013011071 | Ceramco® 3 | Opaceous Dentin A3.5 | 301107 | 2016-09-21 |
| D0013011101 | Ceramco® 3 | Opaceous Dentin i6 | 301110 | 2016-09-21 |
| D0013011181 | Ceramco® 3 | Opaceous Dentin C2 | 301118 | 2016-09-21 |
| D0013011221 | Ceramco® 3 | Opaceous Dentin D3 | 301122 | 2016-09-21 |
| D0013011501 | Ceramco® 3 | Dentin C4 | 301150 | 2016-09-21 |
| D0013011611 | Ceramco® 3 | Dentin Modifier A3.5 | 301161 | 2016-09-21 |
| D0013011671 | Ceramco® 3 | Dentin Modifier Blue | 301167 | 2016-09-21 |
| D0013012001 | Ceramco® 3 | Natural Enamel White | 301200 | 2016-09-21 |
| D0013012011 | Ceramco® 3 | Natural Enamel Extra Light | 301201 | 2016-09-21 |
| D0013013221 | Ceramco® 3 | Overglaze | 301322 | 2016-09-21 |
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