SIMPLISEAL— 510(k) K093208

Substantially Equivalent

Discus Dental, LLC

FDA 510(k) clearance K093208 for SIMPLISEAL, Substantially Equivalent on 2010-02-12. Applicant: Discus Dental, LLC. Device class: 2.

Clearance details

Applicant: Discus Dental, LLC
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2009-10-13
Decision date: 2010-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KIF

K262050 — Vioseal X2026-09-11
K253909 — NeoPEX Pre-Mixed Obturation Paste2026-09-04
K261514 — Calcium Hydroxide Temporary Filling Material (KP-Cal)2026-08-25
K261415 — Injectable Root Canal Sealer (KP-Root SP)2026-06-29
K253167 — Any-Paste2026-01-12

More clearances from Discus Dental, LLC

K102639 — SL32010-12-01
K101612 — ZEN CORDLESS PROPHY SYSTEM2010-06-30
K101215 — NUANCE2010-05-12
K092417 — INSIGHT ULTRASONIC INSERTS2009-12-11

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