FDA UDI
In Commercial Distribution
🇺🇸 United States
SSW CARBIDE CAD CAM
DI: D690SSWAMG25304720022
·
Model: CC-AMG-253047-20-02
·
Ss White Burs, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SSW CARBIDE CAD CAM
- Primary DI
- D690SSWAMG25304720022
- Version / Model
- CC-AMG-253047-20-02
- Catalog Number
- SSWAMG2530472002
- Company Name
- Ss White Burs, Inc.
- Labeler DUNS
- 151760014
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-18
- Public Version
- 2
- Public Version Date
- 2025-05-06
- Public Version Status
- Update
- Public Device Record Key
- 0dd462cd-2e2c-4bec-b231-5fb81e90bb7f
Device Description
CAD/CAM CARBIDE DURADI SSWAMG-253047-20-02 - 1 PACK
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EJL | BUR, DENTAL | Dental | 872.3240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34816 | Dental laboratory bur | A rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, a hard material (e.g., particles of diamond or tungsten carbide), and which is designed to fit into a dental laboratory handpiece that provides the rotation and that is intended for dental laboratory use only to cut hard structures (e.g., metals, plastics, porcelains), during the fabrication of dental restorations. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D690SSWAMG25304720022 | HIBCC |
Customer Contacts
- Phone
- +1(732)905-1100
- [email protected]