PREMIER ULTRASONIC SCALER AND INSERTS— 510(k) K010195

Name: FDA 510(k) clearance K010195
Creator: U.S. Food and Drug Administration
Published: 2001-04-17

Substantially Equivalent

Premier Dental Products Co.

FDA 510(k) clearance K010195 for PREMIER ULTRASONIC SCALER AND INSERTS, Substantially Equivalent on 2001-04-17. Applicant: Premier Dental Products Co.. Device class: 2.

Clearance details

Applicant: Premier Dental Products Co.
Product code: Code ELC
Device class: Class 2
Regulation: 21 CFR 872.4850
Advisory panel: Dental
Date received: 2001-01-22
Decision date: 2001-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: King Of Prussia, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ELC

view all

K260773 — Varios Combi Pro22026-03-10
K253254 — GBT Machine Airflow Prophylaxis Master2026-01-28
K251689 — VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10) +2 more2025-09-19
K242317 — Integrated Endo System (Meet Endo-II)2025-02-13
K233844 — OdneClean2024-08-08

More clearances from Premier Dental Products Co.

view all

K141839 — PREMIER ETCH2014-11-17
K132526 — KNIT-PAK+2013-11-26
K131212 — PREMIER CERAMIC PRIMER2013-08-26
K083695 — TRAXODENT2009-04-28
K062166 — ENAMEL PRO2006-11-21

Adverse events under product code ELC

product code ELC

Malfunction: 1,255
Total: 1,255

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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