HEMA-PRIMER— 510(k) K895750

Substantially Equivalent

Parkell

FDA 510(k) clearance K895750 for HEMA-PRIMER, Substantially Equivalent on 1989-12-21. Applicant: Parkell. Device class: 2.

Clearance details

Applicant: Parkell
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 1989-09-26
Decision date: 1989-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmingdale, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLE

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K260430 — Porcelain Etch Gel2026-04-10
K252450 — Adhese 22026-03-05
K260682 — Bond-PR Universal Adhesive2026-03-03
K251587 — VITA VMLC Primer2026-02-23

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
K892003 — ABRAKADABRA - DENTAL ADHESIVE SYSTEM1989-06-07

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