PRISMA SEAL— 510(k) K802562

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K802562 for PRISMA SEAL, Substantially Equivalent on 1980-11-12. Applicant: Dentsply Intl.. Device class: 2.

Clearance details

Applicant: Dentsply Intl.
Product code: Code EBC
Device class: Class 2
Regulation: 21 CFR 872.3765
Advisory panel: Dental
Date received: 1980-10-16
Decision date: 1980-11-12
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 Dentsply Intl.

K123615 — IRIS - HIGH STRENGTH GLASS CERAMIC2013-02-22
K072730 — FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS2008-03-27
K070538 — XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE2007-03-14
K070019 — CARRARA VOLUMIA2007-01-26
K061427 — PRE-IMPRESSION CONDITIONING SOLUTION2006-06-26

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