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Biotec

FDA UDI

Class I (US FDA UDI)

by Biotec Incorporated

Identity

Trade Name
Biotec FDA UDI
Generic Name
Dental delivery system instrument unit, pneumatic FDA UDI
Device Name
Dental Control Unit FDA UDI
Model / Reference
Control Unit FDA UDI
Description
Dental Control Unit FDA UDI

Identifiers

Primary DI / UDI-DI
00860011235002 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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental delivery system instrument unit, pneumatic

Biotec by Biotec Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental delivery system instrument unit, pneumatic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biotec Incorporated

Sources (1)

  • FDA UDI d1f87ce5-8fc1-444a-9937-91cae63b8342 33 fields · synced Jun 8, 2026