HELIOSEAL F— 510(k) K932078

Substantially Equivalent

Ivoclar North America, Inc.

FDA 510(k) clearance K932078 for HELIOSEAL F, Substantially Equivalent on 1993-09-15. Applicant: Ivoclar North America, Inc.. Device class: 2.

Clearance details

Applicant: Ivoclar North America, Inc.
Product code: Code EBC
Device class: Class 2
Regulation: 21 CFR 872.3765
Advisory panel: Dental
Date received: 1993-04-29
Decision date: 1993-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amherst, NY, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ivoclar North America, Inc.

K012174 — ERIS LAYERING MATERIALS2001-08-27
K011491 — HELIOSEAL CLEAR CHROMA2001-08-16
K011492 — IN TEN-S2001-07-05
K011490 — MODIFICATION TO EXCITE2001-06-27
K011022 — BIOUNIVERSAL PDF2001-05-02

Recalls naming K932078

K-number listed on FDA's recall record

Z-0213-2016 — Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fissure sealant featuring fluoride release. Helioseal fissure sealants are suitable for the sealing of pits, fissures and foramina caeca.Class II·Terminated·Ivoclar A. G.·20151007

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K932078.

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