HELIOSEAL— 510(k) K813015

Substantially Equivalent

Vivadent (Usa), Inc.

FDA 510(k) clearance K813015 for HELIOSEAL, Substantially Equivalent on 1981-12-02. Applicant: Vivadent (Usa), Inc.. Device class: 2.

Clearance details

Applicant: Vivadent (Usa), Inc.
Product code: Code EBC
Device class: Class 2
Regulation: 21 CFR 872.3765
Advisory panel: Dental
Date received: 1981-10-27
Decision date: 1981-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Vivadent (Usa), Inc.

K863831 — VIVADENT FILPIN1986-10-14
K823409 — HELIOSIT-ORTHODONTIC1983-01-21
K802679 — SILANIT1980-12-17
K802681 — HELIOBOND1980-11-24
K802682 — CONTACT SEAL1980-11-24

Recalls naming K813015

K-number listed on FDA's recall record

Z-1026-2016 — Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure SealantClass II·Terminated·Ivoclar Vivadent, Inc.·20160212

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K813015.

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