Cleared Abbreviated

INFILTRATION KIT

K081493 · Dmg USA, Inc. · Dental
Sep 2008
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K081493 is an FDA 510(k) clearance for the INFILTRATION KIT, a Sealant, Pit And Fissure, And Conditioner (Class II — Special Controls, product code EBC), submitted by Dmg USA, Inc. (Ayer, US). The FDA issued a Cleared decision on September 18, 2008, 113 days after receiving the submission on May 28, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.3765.

Submission Details

510(k) Number K081493 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2008
Decision Date September 18, 2008
Days to Decision 113 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBC — Sealant, Pit And Fissure, And Conditioner
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3765

Similar Devices — EBC Sealant, Pit And Fissure, And Conditioner

All 129
Parkell Pit and Fissure Sealant
K243254 · Parkell, Inc. · Aug 2025
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
K232498 · Ultradent Product, Inc. · Aug 2023
Enamel Coating Resin
K230455 · Rizhao Huge Biomaterials Company, Ltd. · Jul 2023
BA Pit & Fissure Sealant
K190998 · Apex Dental Materials, Inc. · Nov 2019
Helioseal F Plus
K190339 · Ivoclar Vivadent, AG · Jul 2019
Pulpdent (Activa) Pit and Fissure Sealant with MCP
K172169 · Pulpdent Corporation · Jan 2018