PERMAQUIK BONDING PRIMER— 510(k) K951583

Name: FDA 510(k) clearance K951583
Creator: U.S. Food and Drug Administration
Published: 1995-05-12

Substantially Equivalent

Ultradent Products, Inc.

FDA 510(k) clearance K951583 for PERMAQUIK BONDING PRIMER, Substantially Equivalent on 1995-05-12. Applicant: Ultradent Products, Inc.. Device class: 2.

Clearance details

Applicant: Ultradent Products, Inc.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 1995-04-06
Decision date: 1995-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Jordan, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLE

view all

K260485 — Any-Etch2026-05-14
K260430 — Porcelain Etch Gel2026-04-10
K252450 — Adhese 22026-03-05
K260682 — Bond-PR Universal Adhesive2026-03-03
K251587 — VITA VMLC Primer2026-02-23

More clearances from Ultradent Products, Inc.

view all

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.