Cleared Traditional

K944068 - RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM)

K944068 is an FDA 510(k) clearance for RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 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 171-day FDA review.

K944068 · Lifecore Biomedical, Inc. · Dental device
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Feb 1995
Decision
171d
Days
Class 2
Risk

K944068 is an FDA 510(k) clearance for the RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM). 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 2, 1995 after a review of 171 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 - K944068

510(k) Number K944068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1994
Decision Date February 02, 1995
Days to Decision 171 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
44d slower than avg
Panel avg: 127d · This submission: 171d
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 K944068.
BRANEMARK SYSTEM SMILINE II
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K944904 · "O" Co., Inc. · Feb 1995
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KIS-II IMPLANT SYSTEM/DRILLS
K944356 · Implant Center of the Palm Beaches · Dec 1994
VIDENT IMPAC IMPLANT ACCESSORIES
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IMPAC TORQUE WRENCH
K940998 · Vident · Nov 1994