STERI-OSS TEMPORARY IMPLANT CEMENT— 510(k) K963078

Name: FDA 510(k) clearance K963078
Creator: U.S. Food and Drug Administration
Published: 1996-09-10

Substantially Equivalent

Steri-Oss, Inc.

FDA 510(k) clearance K963078 for STERI-OSS TEMPORARY IMPLANT CEMENT, Substantially Equivalent on 1996-09-10. Applicant: Steri-Oss, Inc.. Device class: 2.

Clearance details

Applicant: Steri-Oss, Inc.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1996-08-08
Decision date: 1996-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda, CA, US

Download summary PDF View on FDA.gov ↗

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