C-22 PIT & FISSURE SEALANT— 510(k) K844057

Substantially Equivalent

Pentron Corp.

FDA 510(k) clearance K844057 for C-22 PIT & FISSURE SEALANT, Substantially Equivalent on 1984-12-03. Applicant: Pentron Corp.. Device class: 2.

Clearance details

Applicant: Pentron Corp.
Product code: Code EBC
Device class: Class 2
Regulation: 21 CFR 872.3765
Advisory panel: Dental
Date received: 1984-10-18
Decision date: 1984-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, 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 Pentron Corp.

K021457 — FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL2002-08-01
K874189 — DUAL-CURE RADIOPAQUE1988-02-11
K874275 — OPTEC SUPPLEMENTARY KIT1988-01-19
K874162 — OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT1988-01-12
K873683 — CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL)1987-11-16

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