Identity
- Trade Name
- Flight Dental Systems FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece FDA UDI
- Device Name
- The Flight Magnetostrictive Ultrasonic Scaler is designed for use in prophylaxis treatments periodontal, endodontics and other areas of operative dentistry. When used in prophylaxis treatment, the unit operates with a fine warm water spray, requiring little of the physical exertion necessary with hand instruments. It easily and effectively removes stubborn calculus and stains both supra gingival and sub gingival, leaving crown and root surfaces clean and smooth. FDA UDI
- Model / Reference
- FMS-2530 FDA UDI
- Description
- The Flight Magnetostrictive Ultrasonic Scaler is designed for use in prophylaxis treatments periodontal, endodontics and other areas of operative dentistry. When used in prophylaxis treatment, the unit operates with a fine warm water spray, requiring little of the physical exertion necessary with hand instruments. It easily and effectively removes stubborn calculus and stains both supra gingival and sub gingival, leaving crown and root surfaces clean and smooth. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D178FMS25300 FDA UDI
- 510(k) Number
- K040396 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Ultrasonic dental scaling/debridement system handpiece 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
No
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 handpieceUltrasonic dental scaling/debridement system generator
Flight Dental Systems by Flight Dental Systems Usa Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K040396 also covers:
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- Flight Dental Systems — FLIGHT DENTAL SYSTEMS USA INC.
- Flight Dental Systems — Flight Dental Systems
- Flight Dental Systems — Flight Dental Systems
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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
- Flight Dental Systems Usa Inc.
Sources (1)
- FDA UDI 41b038a6-91e6-4213-b926-98cdd9bfbebf 34 fields · synced May 30, 2026