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Delsonic 2000 Scaler 115 V

by Deldent Ltd.

Delsonic 2000 Scaler 115 V (512200) is a Class II device made by Deldent Ltd., cleared under FDA 510(k) K014238 on 24 Jan 2002 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 07290016281941), 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) K014238

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 Number07290016281941 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK014238 Date24 Jan 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K014238 decided 24 Jan 2002 Active
  • FDA GUDID UDI-DI 07290016281941 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K014238
  2. Listed FDA GUDID 07290016281941

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Delsonic 2000 Scaler
Generic name
Ultrasonic dental scaling/debridement system
Model / Ref / Catalog
115 V, 512200
Primary DI / UDI-DI
07290016281941
510(k) Number
FDA product code
ELC
GMDN term
Ultrasonic dental scaling/debridement system
Device class
Class II
Regulation number
872.4850
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Other devices filed under Ultrasonic dental scaling/debridement system.

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Properties

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