BIOCLEAR CONCENTRATE— 510(k) K981565

Name: FDA 510(k) clearance K981565
Creator: U.S. Food and Drug Administration
Published: 1998-10-15

Substantially Equivalent

Waggoner Product Development

FDA 510(k) clearance K981565 for BIOCLEAR CONCENTRATE, Substantially Equivalent on 1998-10-15. Applicant: Waggoner Product Development. Device class: 1.

Clearance details

Applicant: Waggoner Product Development
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 1998-05-01
Decision date: 1998-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIA

view all

K251544 — Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)2026-08-07
K251626 — Midmark Dental Delivery System2025-11-03
K251491 — K5 Cart, K5 Mount, K5 Swing2025-07-17
K243130 — Integral Dental Unit2025-06-27
K242611 — Integral Dental Units2025-05-27

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