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Premium Plus

FDA UDI

Class I (US FDA UDI)

by Premium Plus International Limited

Identity

Trade Name
Premium Plus FDA UDI
Generic Name
Dental power tool system, pneumatic FDA UDI
Device Name
Dental prophy air motor, nose cone, dental handpiece FDA UDI
Model / Reference
1002-4NC FDA UDI
Description
Dental prophy air motor, nose cone, dental handpiece FDA UDI

Identifiers

Primary DI / UDI-DI
D83810024NC4 FDA UDI
510(k) Number
K170261 FDA UDI
FDA Product Code
EFB FDA UDI
GMDN Term
Dental power tool system, 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

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental power tool system, pneumatic

Premium Plus by Premium Plus International Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental power tool system, pneumatic.

Cleared under the same submission

K170261 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Premium Plus International Limited

Sources (1)

  • FDA UDI 40a7a47e-e160-4d62-bb0e-63fabf7b2dd2 34 fields · synced May 30, 2026