Cleared Traditional

IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTECTOR

K946198 · Sterngold · Dental
Jun 1995
Decision
176d
Days
Class 2
Risk

About This 510(k) Submission

K946198 is an FDA 510(k) clearance for the IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTECTOR, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Sterngold (Sunrise, US). The FDA issued a Cleared decision on June 14, 1995, 176 days after receiving the submission on December 20, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K946198 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 1994
Decision Date June 14, 1995
Days to Decision 176 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZE — Implant, Endosseous, Root-form
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640

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