FDA UDI
In Commercial Distribution
🇺🇸 United States
Calcium Hydroxide U.S.P.
DI: D6870010301FG1
·
Model: 0010301FG
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- Calcium Hydroxide U.S.P.
- Primary DI
- D6870010301FG1
- Version / Model
- 0010301FG
- Catalog Number
- 0010301FG
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 3
- Public Version Date
- 2020-06-05
- Public Version Status
- Update
- Public Device Record Key
- 985a341b-ded0-49e5-8ba9-7c2149eb8a1a
Device Description
Calcium Hydroxide USP 2 oz. (57g)
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 |
|---|---|---|---|---|
| EJK | LINER, CAVITY, CALCIUM HYDROXIDE | Dental | 872.3250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47232 | Calcium hydroxide dental suspension | A very basic (high pH) calcium hydroxide (Ca(OH)2) solution (also known as slaked lime or milk of lime) intended to be used in dentistry for a variety of purposes including to flush and disinfect root canals and crowns/bridges before final insertion, and to change the viscosity and/or moisten a temporary tooth filling material. It may also encourage the change of fibroblasts (cells which form the connective tissue of the body) into odontoblast-like cells to produce reparative dentine. 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 | D6870010301FG1 | HIBCC | ||||
| Unit of Use | D6870010301FG0 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 12 bottles (57g each) | ||
| Weight | 57 | Gram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius