Identity
- Trade Name
- Flight Dental Systems FDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, pneumatic FDA UDI
- Model / Reference
- QC-164K FDA UDI
Identifiers
- Primary DI / UDI-DI
- D178QC164K1 FDA UDI
- 510(k) Number
- K181691 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental surgical power tool motorized handpiece/set, pneumatic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 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
Moist Heat or Steam Sterilization FDA UDI
Category: Dental surgical power tool motorized handpiece/set, pneumatic
Flight Dental Systems by Flight Dental Systems Usa Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental surgical power tool motorized handpiece/set, pneumatic.
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Cleared under the same submission
K181691 also covers:
- Flight Dental Systems — FLIGHT DENTAL SYSTEMS USA INC.
- Flight Dental Systems — FLIGHT DENTAL SYSTEMS USA INC.
- Flight Dental Systems — FLIGHT DENTAL SYSTEMS USA INC.
- Flight Dental Systems — Flight Dental Systems
- Flight Dental Systems — Flight Dental Systems
- Flight Dental Systems — Flight Dental Systems
- Flight Dental Systems — Flight Dental Systems
- Flight Dental Systems — Flight Dental Systems
- Flight Dental Systems — Flight Dental Systems
- Flight Dental Systems — Flight Dental Systems
- Flight Dental Systems — Flight Dental Systems
- Flight Dental Systems — Flight Dental Systems
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
- Flight Dental Systems Usa Inc.
Sources (1)
- FDA UDI 3e894dc9-42f2-49ba-a67a-d2d889bf6cc6 33 fields · synced Jun 8, 2026