Identity
- Trade Name
- MECTRON FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system FDA UDI
- Device Name
- The Compact Piezo P2K device is an ultrasonic scaler intended for use, with the appropriate associated insert tips, in the following dental applications: Scaling: All general procedures for removal of supragingival and interdental calculus/plaque deposits. Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning. Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha condensation and Retrograde preparation. Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation. FDA UDI
- Model / Reference
- COMPACT-PIEZO P2K FDA UDI
- Description
- The Compact Piezo P2K device is an ultrasonic scaler intended for use, with the appropriate associated insert tips, in the following dental applications: Scaling: All general procedures for removal of supragingival and interdental calculus/plaque deposits. Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning. Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha condensation and Retrograde preparation. Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation. FDA UDI
Identifiers
- Catalog Number
- 04000079 FDA UDI
- Primary DI / UDI-DI
- E322040000790 FDA UDI
- 510(k) Number
- K102218 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
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Cleared under the same submission
K102218 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 30081f28-9d33-42f5-82d5-229559a1ab48 37 fields · synced May 30, 2026