FDA UDI
In Commercial Distribution
🇺🇸 United States
BUSCH®, BNA®
DI: D8120455561
·
Model: 9590F 140 SOFT DISC FINE
·
BUSCH & CO. GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- BUSCH®, BNA®
- Primary DI
- D8120455561
- Version / Model
- 9590F 140 SOFT DISC FINE
- Catalog Number
- 045556
- Company Name
- BUSCH & CO. GmbH & Co. KG
- Labeler DUNS
- 315658617
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2025-12-15
- Public Version
- 1
- Public Version Date
- 2025-12-23
- Public Version Status
- New
- Public Device Record Key
- 736ba487-8dc5-4ba6-bee6-c36808e4445e
Device Description
Polisher, Soft Disc disc, fine grit for shine-polishing
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
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EHJ | DISK, ABRASIVE | Dental | 872.6010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64617 | Dental abrasive disk, single-use | A dental instrument consisting of a circular flat or slightly conical sheet, which may carry or contain an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations (e.g., dentures, fillings, crowns). It is designed to be fixed at its centre to a laboratory mandrel or lathe, and/or intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D8120455560 | HIBCC | ||||
| Primary | D8120455561 | HIBCC |