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Hu-Friedy UI30PPSC

by Hu-Friedy Mfg Co., LLC

Hu-Friedy UI30PPSC is a medical device (FDA Class II; FDA product code ELC, Scaler, ultrasonic) made by Hu-Friedy Mfg Co., LLC, cleared under FDA 510(k) K012060 on 27 Jul 2001 and listed in FDA GUDID since 13 Dec 2019 (UDI-DI 10889950121693), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K012060

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10889950121693 UDI-DI Date13 Dec 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK012060 Date27 Jul 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K012060 decided 27 Jul 2001 Active
  • FDA GUDID UDI-DI 10889950121693 listed 13 Dec 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K012060
  2. Listed FDA GUDID 10889950121693

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Hu-Friedy
Generic name
Ultrasonic dental scaling/debridement system handpiece
Model / Ref / Catalog
UI30PPSC
Primary DI / UDI-DI
10889950121693
510(k) Number
FDA product code
ELC
GMDN term
Ultrasonic dental scaling/debridement system handpiece
Device class
Class II
Regulation number
872.4850
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Safe

Related devices

Category: Ultrasonic dental scaling/debridement system handpiece

Cleared under the same submission (K012060)

and 2 more cleared under K012060

Similar devices

Other devices filed under FDA product code ELC (Scaler, ultrasonic).

Other devices from Hu-Friedy Mfg Co., LLC

See all devices from Hu-Friedy Mfg Co., LLC →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)