FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Enhance® PoGo® Polishing System
DI: D0026620241
·
Model: 662024
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Enhance® PoGo® Polishing System
- Primary DI
- D0026620241
- Version / Model
- 662024
- Catalog Number
- 662024
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-13
- Public Version
- 3
- Public Version Date
- 2024-06-03
- Public Version Status
- Update
- Public Device Record Key
- ff6ce26a-f5ea-4e55-a37c-a47105e89a09
- Distribution End Date
- 2024-06-01
Device Description
Enhance® PoGo® Sample Package
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZP | INSTRUMENT, DIAMOND, DENTAL | Dental | 872.4535 | 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 |
|---|---|---|---|---|---|---|
| Primary | D0026620241 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1 Polishing Disc, 1 Polishing Point, 1 Polishing Cup |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 27 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Dry storage is recommended.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use after expiration date.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid direct sunlight.