FILE-EZE— 510(k) K934415

Substantially Equivalent

Ultradent Products, Inc.

FDA 510(k) clearance K934415 for FILE-EZE, Substantially Equivalent on 1994-04-13. Applicant: Ultradent Products, Inc.. Device class: Unclassified.

Clearance details

Applicant: Ultradent Products, Inc.
Product code: Code KJJ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1993-09-10
Decision date: 1994-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Oswego, OR, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KJJ

K250279 — RC-SwiftPrep2025-07-02
K241354 — Sealer Solvent2024-08-27
K201785 — EPIEN Dental Cleanser2021-09-09
K211813 — Triton2021-08-18
K193357 — V-Mix2020-10-23

More clearances from Ultradent Products, Inc.

K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261404 — UltraEZ2026-04-30
K240743 — Peak Universal Bond2024-03-20
K240694 — FORMA Composite (Shade A3D)2024-03-15
K221909 — J-Temp2022-07-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.