← Back to catalogue

Hu-Friedy

FDA UDI

Class II (US FDA UDI)

by Hu-Friedy Mfg Co., Llc

Identity

Trade Name
Hu-Friedy FDA UDI
Generic Name
Ultrasonic dental scaling/debridement system handpiece FDA UDI
Device Name
Power Plus Standard Beveled Swivel, 30k FDA UDI
Model / Reference
UI30PPSB FDA UDI
Description
Power Plus Standard Beveled Swivel, 30k FDA UDI

Identifiers

Catalog Number
UI30PPSB FDA UDI
Primary DI / UDI-DI
10889950124960 FDA UDI
510(k) Number
K012060 FDA UDI
FDA Product Code
ELC FDA UDI
GMDN Term
Ultrasonic dental scaling/debridement system handpiece FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4850 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
MRI Safety
MR Safe FDA UDI

Category: Ultrasonic dental scaling/debridement system handpiece

Hu-Friedy by Hu-Friedy Mfg Co., Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasonic dental scaling/debridement system handpiece.

Cleared under the same submission

K012060 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Hu-Friedy Mfg Co., Llc

Sources (1)

  • FDA UDI 3ffd2b89-eb5f-4849-84bf-7cc39ee6cb6a 36 fields · synced May 30, 2026