FDA UDI
In Commercial Distribution
🇺🇸 United States
Crescent® Wig-L-Bug
DI: D002C320003B0
·
Model: C32003B
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Crescent® Wig-L-Bug
- Primary DI
- D002C320003B0
- Version / Model
- C32003B
- Catalog Number
- C32003B
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-02
- Public Version
- 1
- Public Version Date
- 2019-04-10
- Public Version Status
- New
- Public Device Record Key
- bb16a054-d125-4f1e-98c2-3e74ca315b9c
Device Description
Crescent Wig-L-Bug Amalgamator Model 3110-B (Industrial)
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 |
|---|---|---|---|---|
| EFD | AMALGAMATOR, DENTAL, AC-POWERED | Dental | 872.3100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10082 | Dental amalgam mixer | A mains electricity (AC-powered) device used to shake a homogenous mixture of fine dental alloy particles [e.g., tin (Sn), silver (Ag), zinc (Zn), or copper (Cu)] with mercury (Hg) to obtain a dental amalgam, typically right before application. The amalgam is usually prepared in an appropriate capsule that may or may not be an integral part of the device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D002C320003B0 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1x Cresent Wig-L- Bug Amalgamator Model 3110-B (Industrial) |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- For indoor use only, and in temperatures of 5-40 degrees Celsius.
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius