Cleared Traditional

STARTANIUS DENTAL IMPLANT SYSTEM

K854749 · Park Dental Research Corp. · Dental
Mar 1986
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K854749 is an FDA 510(k) clearance for the STARTANIUS DENTAL IMPLANT SYSTEM, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Park Dental Research Corp. (New York, US). The FDA issued a Cleared decision on March 6, 1986, 100 days after receiving the submission on November 26, 1985. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K854749 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 1985
Decision Date March 06, 1986
Days to Decision 100 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

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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