Identity
- Trade Name
- MECTRON FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI
- Device Name
- Tip holder tended for preparation of implant cleaning, The package includes insert and K10 torque wrench (DI Number E322029001370) FDA UDI
- Model / Reference
- D07102 + K10 -US FDA UDI
- Description
- Tip holder tended for preparation of implant cleaning, The package includes insert and K10 torque wrench (DI Number E322029001370) FDA UDI
Identifiers
- Catalog Number
- 02990007-101 FDA UDI
- Primary DI / UDI-DI
- E322029900071010 FDA UDI
- 510(k) Number
- K231391 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Ultrasonic dental scaling/debridement system handpiece tip, periodontal 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
Yes
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, periodontal
Mectron by Mectron Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasonic dental scaling/debridement system handpiece tip, periodontal.
- Streamline PLUS — HU-FRIEDY MFG CO., LLC · Class II
- WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- Cavitron® — Dentsply Professional · Class II
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- Cavitron® — Dentsply Professional · Class II
- Plastic Scaler Connector — OSSTEM IMPLANT Co., Ltd. · Class I
- PIEZON — E.M.S. Electro Medical Systems S.A. · Class II
- Plastic Scaler Connector — OSSTEM IMPLANT Co., Ltd. · Class I
Cleared under the same submission
K231391 also covers:
- HuFriedyGroup — HU-FRIEDY MFG CO., LLC
- HuFriedyGroup — HU-FRIEDY MFG CO., LLC
- HuFriedyGroup — HU-FRIEDY MFG CO., LLC
- HuFriedyGroup — HU-FRIEDY MFG CO., LLC
- HuFriedyGroup — HU-FRIEDY MFG CO., LLC
- HuFriedyGroup — HU-FRIEDY MFG CO., LLC
- PWR Handpiece — HU-FRIEDY MFG CO., LLC
- PWR Handpiece — HU-FRIEDY MFG CO., LLC
- PWR Handpiece — HU-FRIEDY MFG CO., LLC
- PWR Pair — HU-FRIEDY MFG CO., LLC
- Subgingival PWR Perio Tips — HU-FRIEDY MFG CO., LLC
- MECTRON — MECTRON SPA
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 546ee630-6ddf-4f64-a0e6-5e88a541f669 36 fields · synced Jun 1, 2026