PANAVIA TC, AND PANAVIA OPAQUE— 510(k) K862232

Substantially Equivalent

Kuraray Co.

FDA 510(k) clearance K862232 for PANAVIA TC, AND PANAVIA OPAQUE, Substantially Equivalent on 1986-07-29. Applicant: Kuraray Co.. Device class: 2.

Clearance details

Applicant: Kuraray Co.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1986-06-11
Decision date: 1986-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

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 Kuraray Co.

K990040 — CLEARFIL SE BOND1999-02-04
K951813 — CARIES DETECTOR1995-07-11
K933030 — PANAVIA 211994-02-24
K925383 — PHOTO CLEARFIL OPAQUER1993-01-28
K925404 — CLEARFIL PORCELAIN BOND ACTIVATOR1993-01-11

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