COMPUDENT STA— 510(k) K061904

Substantially Equivalent

Milestone Scientific, Inc.

FDA 510(k) clearance K061904 for COMPUDENT STA, Substantially Equivalent on 2006-08-08. Applicant: Milestone Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Milestone Scientific, Inc.
Product code: Code EJI
Device class: Class 2
Regulation: 21 CFR 872.6770
Advisory panel: Dental
Date received: 2006-07-05
Decision date: 2006-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EJI

K171254 — LeEject 2 Dental Syringe and Needle System2017-11-16
K142414 — Miltex N-Tralig Intraligamentary Syringe2014-10-30
K120659 — HU-FRIEDY DENTAL CARTRIDGE SYRINGE2012-11-06
K113247 — ANESTHESIA INJECTION TOOL SET2012-03-27
K082249 — MORPHEUS2009-12-31

More clearances from Milestone Scientific, Inc.

K221702 — CompuFlo Epidural Computer Controlled Anesthesia System2023-02-25
K161883 — CompuFlo Epidural Computer Controlled Anesthesia System2017-06-09
K053554 — COMPUFLO2006-07-10

Recalls naming K061904

K-number listed on FDA's recall record

Z-1952-2015 — Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue. Model Number STA-5050-305. The Wand STA handpiece is a single use syringe used in conjunction with the CompuDent STA computer controlled dental injection system.Class III·Terminated·Milestone Scientific, Inc.·20150211

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061904.

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