Issued: 12/2/11
Region: Northeast
Category: Device 483s
Inspection date range: 11/29/11-12/2/11
Pages: 3
Company: Ivoclar Vivadent, Inc.
175 Pineview Dr.
Buffalo, NY 14228
Inspector(s): Marc S. Neubauer
Observations: Procedures for design validation have not been adequately established.
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