Identity
- Trade Name
- Flight Dental Systems FDA UDI
- Generic Name
- Dental delivery system instrument unit, pneumatic FDA UDI
- Device Name
- The A12 Operatory Package is a hydraulic dental chair with a radius swing mount delivery system. The dental chair features an ergonomic back and seat with synchronized movement. The chair also has the ability to rotate 30 degrees to the left and right FDA UDI
- Model / Reference
- A12H-100 FDA UDI
- Description
- The A12 Operatory Package is a hydraulic dental chair with a radius swing mount delivery system. The dental chair features an ergonomic back and seat with synchronized movement. The chair also has the ability to rotate 30 degrees to the left and right FDA UDI
Identifiers
- Catalog Number
- A12 Operatory Package FDA UDI
- Primary DI / UDI-DI
- D178A12HP1000 FDA UDI
- 510(k) Number
- K070196 FDA UDI
- FDA Product Code
- EIA FDA UDI
- GMDN Term
- Dental delivery system instrument unit, pneumatic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 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: Dental delivery system instrument unit, pneumatic
Flight Dental Systems by Flight Dental Systems Usa Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 2a876a19-f71d-41e0-8dc7-14c977448977 35 fields · synced Jun 8, 2026