Cleared Traditional

K950624 - HA- AND TPS- RESTORE SELF TAPPING DENTA...

K950624 is the FDA 510(k) clearance for HA- AND TPS- RESTORE SELF TAPPING DENTA... by Lifecore Biomedical, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K950624 · Lifecore Biomedical, Inc. · Dental device
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Aug 1995
Decision
201d
Days
Class 2
Risk

K950624 is an FDA 510(k) clearance for the HA- AND TPS- RESTORE SELF TAPPING 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 August 30, 1995 after a review of 201 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 K950624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1995
Decision Date August 30, 1995
Days to Decision 201 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
74d slower than avg
Panel avg: 127d · This submission: 201d
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 K950624.
BRANEMARK SYSTEM OVOID & U-SHAPED BAR SYSTEM
K952886 · Nobelpharma USA, Inc. · Sep 1995
COMBINATION KIT
K953331 · Steri-Oss, Inc. · Sep 1995
LABORATORY SUPPLIES
K953380 · Steri-Oss, Inc. · Sep 1995
LAPPING TOOL KIT
K953103 · Steri-Oss, Inc. · Aug 1995
BRANEMARK SYSTEM BALL ATTACHMENT SYSTEM
K952676 · Nobelpharma USA, Inc. · Aug 1995
3I ASYST ABUTMENT PACKAGE SYSTEM
K951553 · Implant Innovations, Inc. · Jun 1995