Identity
- Trade Name
- Parkell® FDA UDI
- Generic Name
- Diamond dental bur, single-use FDA UDI
- Device Name
- SE4F Sterile FG Diamond Burs, Finishing, Fine Grit FDA UDI
- Model / Reference
- SDS-SE4F FDA UDI
- Description
- SE4F Sterile FG Diamond Burs, Finishing, Fine Grit FDA UDI
Identifiers
- Catalog Number
- SDS-SE4F FDA UDI
- Primary DI / UDI-DI
- 10810000528087 FDA UDI
- FDA Product Code
- DZP FDA UDI
- GMDN Term
- Diamond dental bur, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4535 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.5 Millimeter FDA UDILength — 4.0 Millimeter FDA UDI
Parkell® by Parkell, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Parkell, Inc.
Sources (1)
- FDA UDI aea8f503-b273-4d11-a30a-57e1d5320b1a 37 fields · synced May 30, 2026