Identity
- Trade Name
- Parkell® FDA UDI
- Generic Name
- Diamond dental bur, single-use FDA UDI
- Device Name
- Spiral Round-End Taper Coarse Grit FG Diamond ISO# 198-017 (Pkg. of 10 pcs.) FDA UDI
- Model / Reference
- SD198-017 FDA UDI
- Description
- Spiral Round-End Taper Coarse Grit FG Diamond ISO# 198-017 (Pkg. of 10 pcs.) FDA UDI
Identifiers
- Catalog Number
- SD198-017 FDA UDI
- Primary DI / UDI-DI
- 10810000526489 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization 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 8e774a40-081f-4a92-849a-d09c6f6239c1 36 fields · synced Jun 6, 2026