Cleared Traditional

PS3 TITANIUM SCREW DENTAL IMPLANT

K800762 · Colmed, Ltd. · Dental
May 1980
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K800762 is an FDA 510(k) clearance for the PS3 TITANIUM SCREW DENTAL IMPLANT, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Colmed, Ltd. (Mchenry, US). The FDA issued a Cleared decision on May 14, 1980, 37 days after receiving the submission on April 7, 1980. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K800762 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1980
Decision Date May 14, 1980
Days to Decision 37 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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