FDA UDI
In Commercial Distribution
🇺🇸 United States
Buffalo Dental Mfg
DI: 00850043381532
·
Model: 5860
·
Buffalo Dental Manufacturing Co., Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Buffalo Dental Mfg
- Primary DI
- 00850043381532
- Version / Model
- 5860
- Catalog Number
- 5860
- Company Name
- Buffalo Dental Manufacturing Co., Inc.
- Labeler DUNS
- 001372853
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-11
- Public Version
- 1
- Public Version Date
- 2023-08-21
- Public Version Status
- New
- Public Device Record Key
- afb47edb-2fc5-4e12-856d-35aaee6d3cde
Device Characteristics
- Single Use
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EFW | Toothbrush, Manual | Dental | 872.6855 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46940 | Dental polishing brush | A rotational device, typically composed of a metal shaft with bristles containing silicium carbide material, that is used for the quick grinding and polishing of dental composite materials and hard dental tissues to produce a high shine. It is held in a dental handpiece, which rotates the brush at high speeds [e.g., 5000 revolutions per minute (rpm)]. It is suitable for interproximal areas and occlusal surfaces. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850043381532 | GS1 |