Cleared Traditional

MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM

K994205 · Lifecore Biomedical, Inc. · Dental
Feb 2000
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K994205 is an FDA 510(k) clearance for the MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Lifecore Biomedical, Inc. (Chaska, US). The FDA issued a Cleared decision on February 29, 2000, 90 days after receiving the submission on December 1, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K994205 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 1999
Decision Date February 29, 2000
Days to Decision 90 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

Similar Devices — DZE Implant, Endosseous, Root-form

All 1539
Straumann? BLC Implants - Indication Widening
K252168 · Institut Straumann AG · Mar 2026
Dentis SQ-SL AXEL Fixture
K253493 · Dentis Co., Ltd. · Mar 2026
Nobel Biocare S Series Implants
K252197 · Nobel Biocare AB · Feb 2026
BIORES Dental Implant System
K252286 · Chengdu Besmile Medical Technology Co., Ltd. · Feb 2026
ZENEX Implant System_R-System
K252585 · Izenimplant Co., Ltd. · Jan 2026
GEN5? and GEN5+? 3.3mmD Dental Implants
K252145 · Paragon Implant Mfg., LLC · Dec 2025