Identity
- Trade Name
- MECTRON FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system FDA UDI
- Device Name
- The COMPACT-PIEZO P2K LED is an ultrasonic scaler device intended for use, with the appropriate associated insert tips, in the following dental applications: • Scaling: Procedures for removal of supragingival/subgingival and interdental calculus/plaque deposits; • Periodontology: Periodontal therapy and debridement for periodontal diseases, including periodontal pocket irrigation and cleaning; • Endodontics: Treatments for root canal reaming irrigation, revision, filling, gutta-percha condensation and retrograde preparation; • Restorative and Prosthetics: Restorative procedures including cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations, inlay/onlay condensation and implants/restorations cleaning. FDA UDI
- Model / Reference
- COMPACT-PIEZO P2K LED FDA UDI
- Description
- The COMPACT-PIEZO P2K LED is an ultrasonic scaler device intended for use, with the appropriate associated insert tips, in the following dental applications: • Scaling: Procedures for removal of supragingival/subgingival and interdental calculus/plaque deposits; • Periodontology: Periodontal therapy and debridement for periodontal diseases, including periodontal pocket irrigation and cleaning; • Endodontics: Treatments for root canal reaming irrigation, revision, filling, gutta-percha condensation and retrograde preparation; • Restorative and Prosthetics: Restorative procedures including cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations, inlay/onlay condensation and implants/restorations cleaning. FDA UDI
Identifiers
- Catalog Number
- 04000091 FDA UDI
- Primary DI / UDI-DI
- E322040000910 FDA UDI
- 510(k) Number
- K151023 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Ultrasonic dental scaling/debridement system 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ultrasonic dental scaling/debridement system
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.
- Henry Schein — HENRY SCHEIN, INC. · Class II
- BioSonic — Coltene/Whaledent Inc. · Class II
- TurboSENSOR™ — PARKELL, INC. · Class II
- DTE, WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
- PIEZO Tip BE-2 — BONART CO., LTD. · Class II
- SONICflex prep crown plain No. 98 — KaVo Dental GmbH · Class I
- Baolai — Nanning Baolai Medical Instrument Co., Ltd. · Class II
Cleared under the same submission
K151023 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mectron Spa
Sources (1)
- FDA UDI 8dc7cf93-fa35-412e-9992-e9203e7e96a5 36 fields · synced Jun 8, 2026