FDA UDI
In Commercial Distribution
🇺🇸 United States
ZOE B&T® Base and Temporary Filling Material
DI: D0026101020
·
Model: 610102
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- ZOE B&T® Base and Temporary Filling Material
- Primary DI
- D0026101020
- Version / Model
- 610102
- Catalog Number
- 610102
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 5
- Public Version Date
- 2025-08-18
- Public Version Status
- Update
- Public Device Record Key
- ecf0a006-b674-4357-a1e3-24f0956d131e
Device Description
ZOE B&T® Base and Temporary Filling Material Refill, Liquid, 1 Bottle
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EMB | ZINC OXIDE EUGENOL | Dental | 872.3275 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62200 | Zinc oxide eugenol dental cement | A 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 (e.g., rosin/colophony). After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D0026101020 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 14 | Milliliter | |
| Device Size Text, specify | 1 Bottle Liquid (14mL) |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight. Keep dry.