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Proma

FDA UDI

Class I (US FDA UDI)

by Proma, Inc.

Identity

Trade Name
Proma 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
D142DCU01 FDA UDI
510(k) Number
K980106 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental delivery system instrument unit, pneumatic

Proma by Proma, Inc. — 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
Proma, Inc.

Sources (1)

  • FDA UDI 4edd83db-4b8f-4cd1-9f08-8fe1b8278db4 34 fields · synced May 30, 2026