HELIOBOND— 510(k) K802681

Substantially Equivalent

Vivadent (Usa), Inc.

FDA 510(k) clearance K802681 for HELIOBOND, Substantially Equivalent on 1980-11-24. Applicant: Vivadent (Usa), Inc.. Device class: 2.

Clearance details

Applicant: Vivadent (Usa), Inc.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 1980-10-28
Decision date: 1980-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLE

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K252450 — Adhese 22026-03-05
K260682 — Bond-PR Universal Adhesive2026-03-03
K251587 — VITA VMLC Primer2026-02-23

More clearances from Vivadent (Usa), Inc.

K863831 — VIVADENT FILPIN1986-10-14
K823409 — HELIOSIT-ORTHODONTIC1983-01-21
K813015 — HELIOSEAL1981-12-02
K802679 — SILANIT1980-12-17
K802682 — CONTACT SEAL1980-11-24

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