Identity
- Trade Name
- Parkell® FDA UDI
- Generic Name
- Diamond dental bur, single-use FDA UDI
- Device Name
- 859-014VF Sterile FG Diamond Burs, Needle, Very Fine Grit FDA UDI
- Model / Reference
- SDS-859-014VF FDA UDI
- Description
- 859-014VF Sterile FG Diamond Burs, Needle, Very Fine Grit FDA UDI
Identifiers
- Catalog Number
- SDS-859-014VF FDA UDI
- Primary DI / UDI-DI
- 10810000527929 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
- 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 — 1.4 Millimeter FDA UDILength — 10.0 Millimeter FDA UDI
Category: Diamond dental bur, single-use
Parkell® by Parkell, Inc. — Class I — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Parkell, Inc.
Sources (2)
- FDA UDI ed13eabb-08cd-429f-85bc-7c9499a84ed3 36 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced May 29, 2026