Cleared Traditional

K944069 - RESTORE TPS LHEX CYLINDER ENDOSSEOUS IM...

K944069 is the FDA 510(k) clearance for RESTORE TPS LHEX CYLINDER ENDOSSEOUS IM... by Lifecore Biomedical, Inc.. It is a Class 2 Dental device (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

Submission Details

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.

Device Classification

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 611
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K944069.
RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM)
K951111 · Lifecore Biomedical, Inc. · Mar 1995
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K944158 · Steri-Oss, Inc. · Mar 1995
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K944683 · Nobelpharma USA, Inc. · Mar 1995
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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