Ultrasonic Scaler Insert DF100/25K R

by Deldent Ltd.

Ultrasonic Scaler Insert DF100/25K R (508605) is a Class II device made by Deldent Ltd., cleared under FDA 510(k) K011179 on 5 Jun 2001 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 07290016281156), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number07290016281156 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK011179	Date5 Jun 2001Decided	StatusActive

Official records

AccessGUDID record UDI-DI 07290016281156
FDA 510(k) database 510(k) number K011179

Across registries

2 registries list this device

FDA 510(k) K011179 decided 5 Jun 2001 Active
FDA GUDID UDI-DI 07290016281156 listed 24 Sep 2016 Listed

Timeline

2 dated events

5 Jun 2001 Cleared FDA 510(k) K011179
24 Sep 2016 Listed FDA GUDID 07290016281156

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Ultrasonic Scaler Insert
Generic name: Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Model / Ref / Catalog: DF100/25K R, 508605

Primary DI / UDI-DI: 07290016281156
510(k) Number: K011179
FDA product code: ELC
GMDN term: Ultrasonic dental scaling/debridement system handpiece tip, periodontal

Device class: Class II
Regulation number: 872.4850
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Similar devices

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

Other devices from Deldent Ltd.

Ultrasonic Scaler Insert DF100/30K R

Class II
Jetpolisher 2000 Midwest 1.1

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Ultrasonic Scaler Insert DP100/25K L

Class II
Ultrasonic Scaler Insert DF1000/30K

Class II

See all devices from Deldent Ltd. →

Properties

Sterilise before use
Prescription use
Lot / batch number

Other properties (12, all answered No)