OPTIBOND FL— 510(k) K031444

Substantially Equivalent

Kerr Dental Materials Center

FDA 510(k) clearance K031444 for OPTIBOND FL, Substantially Equivalent on 2003-07-02. Applicant: Kerr Dental Materials Center. Device class: 2.

Clearance details

Applicant: Kerr Dental Materials Center
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2003-05-07
Decision date: 2003-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLE

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 Kerr Dental Materials Center

K050984 — BIOPLANT2005-08-11
K030646 — BELLEGLASS POINT 42003-05-06
K020303 — XR PRIMER 22002-04-19
K020178 — BELLEGLASS HP MODELING GEL2002-03-15
K014027 — OPTIBOND SOLO PLUS 42002-02-22

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