COMPOTHIXO— 510(k) K111465

Substantially Equivalent

Kerrhawe SA

FDA 510(k) clearance K111465 for COMPOTHIXO, Substantially Equivalent on 2012-07-25. Applicant: Kerrhawe SA. Device class: 1.

Clearance details

Applicant: Kerrhawe SA
Product code: Code DZN
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 2011-05-26
Decision date: 2012-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZN

K071858 — DENTAL MATRIX BAND2007-08-31
K901919 — CONTACT MOLAR BANDS AND CONTOUR STRIPS1990-06-22
K861581 — CENTRIX PCR MOLAR MATRIX FORMS (BANDS)1986-05-12
K844324 — TIGER BAND1984-12-03
K840984 — INTERDENTAL WEDGES1984-04-13

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