FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Absolute Polishers™
DI: 10810000526007
·
Model: S080
·
PARKELL, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
24
Basic Information
- Brand Name
- Absolute Polishers™
- Primary DI
- 10810000526007
- Version / Model
- S080
- Catalog Number
- S080
- Company Name
- PARKELL, INC.
- Labeler DUNS
- 009900424
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 24
- Record Status
- Published
- Publish Date
- 2019-08-02
- Public Version
- 5
- Public Version Date
- 2023-12-25
- Public Version Status
- Update
- Public Device Record Key
- adfe61d1-9a7b-4b71-a557-90320e3f3cd7
- Distribution End Date
- 2020-03-01
Device Description
Absolute Polishers™; Point Shapers (non-diamond)
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| EJQ | Wheel, Polishing Agent | Dental | 872.6010 | 1 |
| EHJ | Disk, Abrasive | Dental | 872.6010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63517 | Dental abrasive point, single-use | A sterile rotary endpiece designed to be attached to a dental power tool handpiece to perform a specific rotating mechanical function during a dental or orthodontic procedure, typically for polishing and smoothing natural or restorative dental materials (e.g., to finish a crown). Also referred to as a polisher, it is available in various forms [e.g., conical] and sizes and is made of synthetic polymer materials (e.g., silicone, rubber). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10810000526007 | GS1 | ||||
| Unit of Use | 00810000526000 | GS1 |
Customer Contacts
- Phone
- 6312491134
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in cool, dark, dry-humidity environment
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 28 Degrees Celsius