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Flight Dental Systems

FDA UDI

Class I (US FDA UDI)

by Flight Dental Systems Usa Inc.

Identity

Trade Name
Flight Dental Systems FDA UDI
Generic Name
Dental delivery system instrument unit, pneumatic FDA UDI
Device Name
A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system. FDA UDI
Model / Reference
A6EP-100 FDA UDI
Description
A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system. FDA UDI

Identifiers

Primary DI / UDI-DI
D178A6EP1000 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

Similar devices

Also classified as Dental delivery system instrument unit, pneumatic.

Cleared under the same submission

K070196 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Flight Dental Systems Usa Inc.

Sources (1)

  • FDA UDI d0044198-e1eb-43a2-bd18-ca1bc462266f 34 fields · synced May 30, 2026