COVER UP— 510(k) K881914

Substantially Equivalent

Parkell

FDA 510(k) clearance K881914 for COVER UP, Substantially Equivalent on 1988-07-15. Applicant: Parkell. Device class: 2.

Clearance details

Applicant: Parkell
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1988-05-09
Decision date: 1988-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmingdale, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EMA

K254201 — Any-Cem2026-08-13
K261937 — PacTemp Automix NE2026-08-07
K261166 — DIA-CEM2026-07-09
K254109 — G-CEM UNIVERSAL2026-05-18
K253337 — REGEN Bioactive Cement2026-04-15

More clearances from Parkell

K923867 — METAFIL1992-10-06
K905032 — MOUSSE, POLYVINYL SILOXANE IMPRESSION MATERIAL1991-03-15
K900303 — CONNECT1990-04-12
K896719 — PRIMER-P ADHESIVE AGENT1990-02-22
K895750 — HEMA-PRIMER1989-12-21

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