FDA UDI
In Commercial Distribution
🇺🇸 United States
House Brand Dentistry
DI: 00810132809439
·
Model: HSB-411300
·
Frontier Dental Supply Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- House Brand Dentistry
- Primary DI
- 00810132809439
- Version / Model
- HSB-411300
- Company Name
- Frontier Dental Supply Inc
- Labeler DUNS
- 203768304
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2025-05-14
- Public Version
- 2
- Public Version Date
- 2025-06-06
- Public Version Status
- Update
- Public Device Record Key
- 7829211a-a048-4087-a11d-eb017379ac6e
Device Description
HSB - FL2 FG White Mounted Stone,12/Pk. Flame finishing stones. Aluminum Oxide for fine finishing of composites
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ELA | Instrument, Hand, Calculus Removal | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31833 | Dental abrasive point, reusable | A rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10810132809436 | GS1 | ||||
| Primary | 00810132809439 | GS1 |