ZIRBLANK-PS AND ZIRBLANK-FS— 510(k) K070045

Substantially Equivalent

Acucera, Inc.

FDA 510(k) clearance K070045 for ZIRBLANK-PS AND ZIRBLANK-FS, Substantially Equivalent on 2007-03-26. Applicant: Acucera, Inc.. Device class: 2.

Clearance details

Applicant: Acucera, Inc.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2007-01-04
Decision date: 2007-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gyeonggi, KR

Download summary PDF View on FDA.gov ↗

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