FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Astropol
DI: DIVO557625AN1
·
Model: 557625AN
·
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
24
Basic Information
- Brand Name
- Astropol
- Primary DI
- DIVO557625AN1
- Version / Model
- 557625AN
- Catalog Number
- 557625AN
- Company Name
- IVOCLAR VIVADENT AKTIENGESELLSCHAFT
- Labeler DUNS
- 448015938
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 24
- Record Status
- Published
- Publish Date
- 2020-08-26
- Public Version
- 2
- Public Version Date
- 2021-11-08
- Public Version Status
- Update
- Public Device Record Key
- 3f2f9e6f-a622-4c1a-8ebf-e3aeae7f7a14
- Distribution End Date
- 2021-11-05
Device Description
Astropol F small flame, Astropol F large flame, Astropol F cup, Astropol F disc, Astropol P small flame, Astropol P large flame, Astropol P cup, Astropol P disc, Astropol HP small flame, Astropol HP large flame, Astropol HP cup, Astropol HP disc
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| 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 | DIVO557625AN0 | HIBCC | ||||
| Primary | DIVO557625AN1 | HIBCC |