VISIO-SEAL— 510(k) K810950

Substantially Equivalent

Espe Dental Products

FDA 510(k) clearance K810950 for VISIO-SEAL, Substantially Equivalent on 1981-04-29. Applicant: Espe Dental Products. Device class: 2.

Clearance details

Applicant: Espe Dental Products
Product code: Code EBC
Device class: Class 2
Regulation: 21 CFR 872.3765
Advisory panel: Dental
Date received: 1981-04-07
Decision date: 1981-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBC

K260819 — Any-Com Seal2026-05-01
K243254 — Parkell Pit and Fissure Sealant2025-08-08
K232498 — UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio2023-08-18
K230455 — Enamel Coating Resin2023-07-25
K190998 — BA Pit & Fissure Sealant2019-11-08

More clearances from Espe Dental Products

K802819 — KETAC-CEM IN REF. TO K8020481980-11-24
K802049 — NIMETIC-DISPERS1980-09-16
K800031 — PERMADYNE POLYETHER RUBBER IMPRESSION1980-02-05
K771889 — UNIOLITE1977-10-20
K771901 — CAPMIX1977-10-20

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