Identity
- Trade Name
- MECTRON FDA UDI
- Generic Name
- Dental ultrasonic surgical system handpiece tip FDA UDI
- Device Name
- OT1 is an sinus bony window osteotomy dental insert to be used in conjunction with Mectron Piezosurgery handpieces. FDA UDI
- Model / Reference
- OT1 -US FDA UDI
- Description
- OT1 is an sinus bony window osteotomy dental insert to be used in conjunction with Mectron Piezosurgery handpieces. FDA UDI
Identifiers
- Catalog Number
- 03370001-101 FDA UDI
- Primary DI / UDI-DI
- E322033700011010 FDA UDI
- 510(k) Number
- K151248 FDA UDI
- FDA Product Code
- ELC FDA UDIDZI FDA UDI
- GMDN Term
- Dental ultrasonic surgical system handpiece tip FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4850 FDA UDI872.4120 FDA UDI
- Commercial Distribution
- 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
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: Dental ultrasonic surgical system handpiece tip
Mectron by Mectron Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental ultrasonic surgical system handpiece tip.
- ACTEON — Satelec · Class II
- CI Tip — B&L Biotech Co., Ltd. · Class I
- ACTEON — Satelec · Class II
- Vista CT4 (Thin Condensation) Apical Surgery P5 Tip — Vista Dental · Class I
- PIEZON MASTER SURGERY — E.M.S. Electro Medical Systems S.A. · Class II
- PIEZON MASTER SURGERY — E.M.S. Electro Medical Systems S.A. · Class II
- ACTEON — Satelec · Class II
- WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
Cleared under the same submission
K151248 also covers:
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 |
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Manufacturer
- Manufacturer
- Mectron Spa
Sources (1)
- FDA UDI 68a60ef9-ce09-4e4c-86e0-a3bd7e0cb6dc 36 fields · synced May 30, 2026