FDA UDI
In Commercial Distribution
🇺🇸 United States
Caulk® Super Bur®
DI: D0026659351
·
Model: 665935
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
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Basic Information
- Brand Name
- Caulk® Super Bur®
- Primary DI
- D0026659351
- Version / Model
- 665935
- Catalog Number
- 665935
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2019-04-02
- Public Version
- 2
- Public Version Date
- 2020-03-23
- Public Version Status
- Update
- Public Device Record Key
- 7b0c30d7-4370-495f-a8a8-c3c518387c47
Device Description
Caulk Super Bur Clinic Pack - Size 1158 FG
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| EJL | BUR, DENTAL | Dental | 872.3240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16668 | Carbide dental bur, reusable | A rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. 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 | D0026659351 | HIBCC | ||||
| Unit of Use | D0026659350 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 100x Burs - Size 1158 FG Super Bur |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep devices in sterilization packaging in a dry and clean environment.