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ChecQPEG Driver DCQPD

by Dentis Co., Ltd

ChecQPEG Driver DCQPD is a medical device (FDA Class I; FDA product code EKX, Handpiece, Direct Drive, Ac-Powered) made by Dentis Co., Ltd, cleared under FDA 510(k) K241065 on 21 Mar 2025 and listed in FDA GUDID since 31 Mar 2025 (UDI-DI 08800053092593), 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) K241065

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 Number08800053092593 UDI-DI Date31 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK241065 Date21 Mar 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241065 decided 21 Mar 2025 Active
  • FDA GUDID UDI-DI 08800053092593 listed 31 Mar 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K241065
  2. Listed FDA GUDID 08800053092593

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ChecQPEG Driver
Generic name
Dental implant stability resonance frequency analysis unit
Model / reference
DCQPD
Primary DI / UDI-DI
08800053092593
510(k) Number
FDA product code
EKX
GMDN term
Dental implant stability resonance frequency analysis unit
Device class
Class I
Regulation number
872.4200
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Dentis Co., Ltd

See all devices from Dentis Co., Ltd →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)