Cleared Traditional

K991114 - REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM

K991114 is an FDA 510(k) clearance for REGULAR DIAMETER SINGLE STAGE (RDS) TPS..., manufactured by Lifecore Biomedical, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K991114 · Lifecore Biomedical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
104d
Days
Class 2
Risk

K991114 is an FDA 510(k) clearance for the REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Lifecore Biomedical, Inc. (Chaska, US). The FDA issued a Cleared decision on July 14, 1999 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Lifecore Biomedical, Inc. devices

FDA 510(k) Submission Details - K991114

510(k) Number K991114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1999
Decision Date July 14, 1999
Days to Decision 104 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 127d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1269
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K991114.
BICORTICAL SCREW
K983120 · Oraltronics Marketing-Und Vertriebs GmbH · Jul 1999
SYNOCTA PROSTHETICS
K990342 · Straumann USA · Jul 1999
MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM
K990304 · Astra Tech, Inc. · Jul 1999
ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACRO)
K991053 · Astra Tech, Inc. · Jun 1999
SARGON IMMEDIATE LOAD IMPLANT, MODEL D
K981141 · Sargon Ent., Inc. · Jun 1999
REMOVABLE CUFF ABUTMENT
K984536 · Sulzer Calcitek, Inc. · Jun 1999