AMALGAM CARRIER— 510(k) K945220

Substantially Equivalent

Buffalo Dental Mfg. Co., Inc.

FDA 510(k) clearance K945220 for AMALGAM CARRIER, Substantially Equivalent on 1995-01-11. Applicant: Buffalo Dental Mfg. Co., Inc.. Device class: 1.

Clearance details

Applicant: Buffalo Dental Mfg. Co., Inc.
Product code: Code EKI
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1994-10-26
Decision date: 1995-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Syosset, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EKI

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K841323 — FUZZY TRAY1984-06-27
K841490 — POLYSULFIDE CUSTOM TRAY MATERIAL1984-06-27

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