ULTRADENT PRODUCT TOOTH SURFACE DRYING AGENT— 510(k) K921602

Name: FDA 510(k) clearance K921602
Creator: U.S. Food and Drug Administration
Published: 1992-09-09

Substantially Equivalent

Ultradent Products, Inc.

FDA 510(k) clearance K921602 for ULTRADENT PRODUCT TOOTH SURFACE DRYING AGENT, Substantially Equivalent on 1992-09-09. Applicant: Ultradent Products, Inc.. Device class: 2.

Clearance details

Applicant: Ultradent Products, Inc.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1992-04-03
Decision date: 1992-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

view all

K262202 — Cerasmart Forte2026-09-10
K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)2026-08-31
K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

More clearances from Ultradent Products, Inc.

view all

K261404 — UltraEZ2026-04-30
K240743 — Peak Universal Bond2024-03-20
K240694 — FORMA Composite (Shade A3D)2024-03-15
K221909 — J-Temp2022-07-01
K220471 — VALO X, VALO X Accessory Lenses2022-02-22

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