KERR VPS IMPRESSION MATERIAL— 510(k) K050604

Clearance details

Applicant

Sybron Dental Specialties, Inc.

Product code

Product code ELW

Device class

Class 2

Regulation

21 CFR 872.3660

Advisory panel

Dental

Date received

2005-03-09

Decision date

2005-04-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Orange, CA, US

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• Z-0268-2013 — The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is 1815757. Intended as an alternative to traditional alginate materials.Class II·Terminated·Kerr Corporation·20120221

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050604.