DENTO-SURGE— 510(k) K955176

Substantially Equivalent

Ellman Intl., Inc.

FDA 510(k) clearance K955176 for DENTO-SURGE, Substantially Equivalent on 1996-04-15. Applicant: Ellman Intl., Inc.. Device class: 2.

Clearance details

Applicant: Ellman Intl., Inc.
Product code: Code EKZ
Device class: Class 2
Regulation: 21 CFR 872.4920
Advisory panel: Dental
Date received: 1995-11-13
Decision date: 1996-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sound Beach, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EKZ

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K052622 — MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT2005-12-09
K050735 — MC6A2005-05-23

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K001986 — SURGITRON IEC II2000-09-27
K001407 — SURGITRON IEC II2000-07-24
K001253 — SURGITRON IEC II2000-05-26

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