Identity
- Trade Name
- MECTRON FDA UDI
- Generic Name
- Hard-tissue ultrasonic surgical system handpiece tip FDA UDI
- Device Name
- MT2L-4 is an osteotomy surgical insert to be used in conjunction with Mectron Piezosurgery ultrasonic handpieces. FDA UDI
- Model / Reference
- MT2L-4 FDA UDI
- Description
- MT2L-4 is an osteotomy surgical insert to be used in conjunction with Mectron Piezosurgery ultrasonic handpieces. FDA UDI
Identifiers
- Catalog Number
- 03600004 FDA UDI
- Primary DI / UDI-DI
- E322036000040 FDA UDI
- 510(k) Number
- K153743 FDA UDI
- FDA Product Code
- HWE FDA UDIHBE FDA UDIERL FDA UDIDZI FDA UDIJDX FDA UDI
- GMDN Term
- Hard-tissue ultrasonic surgical system handpiece tip FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI882.4310 FDA UDI874.4250 FDA UDI872.4120 FDA UDI888.4580 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental ultrasonic surgical system handpiece tipHard-tissue ultrasonic surgical system handpiece tip
Mectron by Mectron Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hard-tissue ultrasonic surgical system handpiece tip.
- SMTP — SMTP Medical Co., Ltd. · Class II
- Ultra-Drive® Tool — Biomet Orthopedics, Inc. · Class II
- SMTP — SMTP Medical Co., Ltd. · Class II
- ULTRA-DRIVE TOOL — Biomet Orthopedics, Inc. · Class II
- Ultra-Drive® Tool — Biomet Orthopedics, Inc. · Class II
- Ultra-Drive® Tool — Biomet Orthopedics, Inc. · Class II
- ULTRA-DRIVE TOOL — Biomet Orthopedics, Inc. · Class II
- SMTP — SMTP Medical Co., Ltd. · Class II
Cleared under the same submission
K153743 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 I | Pending data |
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Manufacturer
- Manufacturer
- Mectron Spa
Sources (1)
- FDA UDI e89d0419-63cc-440f-9efd-e9ee99a5f4b6 36 fields · synced Jun 1, 2026