FDA UDI
Not in Commercial Distribution
🇺🇸 United States
TC cavity Burs Cylinder Square
DI: J003E129X141012001
·
Model: E129X14101200
·
MAILLEFER INSTRUMENTS HOLDING Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TC cavity Burs Cylinder Square
- Primary DI
- J003E129X141012001
- Version / Model
- E129X14101200
- Catalog Number
- E129X14101200
- Company Name
- MAILLEFER INSTRUMENTS HOLDING Sàrl
- Labeler DUNS
- 480538495
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-20
- Public Version
- 2
- Public Version Date
- 2025-06-06
- Public Version Status
- Update
- Public Device Record Key
- 3c1510f4-5712-4df3-a595-2ba4bba4ff04
- Distribution End Date
- 2023-06-30
Device Description
Dental burs
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
- No
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 | J003E129X141012001 | HIBCC |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- N/A