ZOE B&T® Base and Temporary Filling Material
- Primary DI
- D0026101020
- Brand
- ZOE B&T® Base and Temporary Filling Material
- Company
- DENTSPLY INTERNATIONAL INC.
- Model
- 610102
- Catalog number
- 610102
- Device description
- ZOE B&T® Base and Temporary Filling Material Refill, Liquid, 1 Bottle
- Published
- 2016-09-23
- 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 |
|---|
| EMB | ZINC OXIDE EUGENOL |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EMB | Zinc Oxide Eugenol | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D0026101020 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Zinc oxide eugenol dental cement | A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between eugenol and zinc oxide (ZnO). It typically includes some additional fillers/components. After application, this device cannot be reused. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
| Total Volume | 14 | Milliliter |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Keep away from sunlight. Keep dry. |
Contacts
| Phone | Email |
|---|
| +1(800)532-2855 | MilfordDE-Customer-Service@dentsplysirona.com |
Regulatory Flags
- DUNS number
- 083235549
- Device count
- 1
- 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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| 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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