Identity
- Trade Name
- MECTRON FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece tip, endodontic FDA UDI
- Device Name
- RD4 is a diamond coated scaling insert intended for endodontic retro treatment and to be used in conjunction with Mectron ultrasonic handpieces. The package includes insert and K10 torque wrench (DI Number E322029001370) FDA UDI
- Model / Reference
- RD4 + K10 FDA UDI
- Description
- RD4 is a diamond coated scaling insert intended for endodontic retro treatment and to be used in conjunction with Mectron ultrasonic handpieces. The package includes insert and K10 torque wrench (DI Number E322029001370) FDA UDI
Identifiers
- Catalog Number
- 03050007-001 FDA UDI
- Primary DI / UDI-DI
- E322030500070010 FDA UDI
- 510(k) Number
- K140965 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Ultrasonic dental scaling/debridement system handpiece tip, endodontic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ultrasonic dental scaling/debridement system handpiece tip, endodontic
Mectron by Mectron Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ultrasonic dental scaling/debridement system handpiece tip, endodontic.
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Cleared under the same submission
K140965 also covers:
- HuFriedyGroup — HU-FRIEDY MFG CO., LLC
- HuFriedyGroup — HU-FRIEDY MFG CO., LLC
- HuFriedyGroup — HU-FRIEDY MFG CO., LLC
- PWR Piezo — HU-FRIEDY MFG CO., LLC
- PWR Piezo Tips — HU-FRIEDY MFG CO., LLC
- PWR Piezo Tips — HU-FRIEDY MFG CO., LLC
- PWR Piezo Tips — HU-FRIEDY MFG CO., LLC
- PWR Piezo Tips — HU-FRIEDY MFG CO., LLC
- PWR Piezo Tips — HU-FRIEDY MFG CO., LLC
- PWR Piezo Tips — HU-FRIEDY MFG CO., LLC
- PWR Piezo Tips — HU-FRIEDY MFG CO., LLC
- PWR Piezo Tips — HU-FRIEDY MFG CO., LLC
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mectron Spa
Sources (1)
- FDA UDI 6133e39d-64fa-47f2-9879-606bb24c3db8 36 fields · synced May 30, 2026