Cleared Traditional

K944069 - RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEM

K944069 is an FDA 510(k) clearance for RESTORE TPS LHEX CYLINDER ENDOSSEOUS IM..., 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 194-day FDA review.

K944069 · Lifecore Biomedical, Inc. · Dental device
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Feb 1995
Decision
194d
Days
Class 2
Risk

K944069 is an FDA 510(k) clearance for the RESTORE TPS LHEX CYLINDER ENDOSSEOUS 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 February 28, 1995 after a review of 194 days - an extended review cycle.

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 - K944069

510(k) Number K944069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1994
Decision Date February 28, 1995
Days to Decision 194 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 127d · This submission: 194d
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 1207
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K944069.
KIS-II NON-ANGULATED ABUTMENTS
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IMPLANT BODY RETRIEVER/REMOVER
K946113 · "O" Co., Inc. · Mar 1995
IMPLANT BODY DEPTH GAUGE/TRYIN
K946129 · "O" Co., Inc. · Mar 1995
BRANEMARK SYSTEM MIRUSCONE ABUTMENT SYSTEM
K944964 · Nobelpharma USA, Inc. · Feb 1995
BRANEMARK SYSTEM 17 ANGULATED ABUTMENT
K944962 · Nobelpharma USA, Inc. · Feb 1995
BRANEMARK SYSTEM SMILINE II
K944963 · Nobelpharma USA, Inc. · Feb 1995