Cleared Traditional

K954819 - RESTORE TPS DENTAL IMPLANT SYSTEM SUSTA...

K954819 is the FDA 510(k) clearance for RESTORE TPS DENTAL IMPLANT SYSTEM SUSTA... by Lifecore Biomedical, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K954819 · Lifecore Biomedical, Inc. · Dental device
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Jan 1996
Decision
83d
Days
Class 2
Risk

K954819 is an FDA 510(k) clearance for the RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN 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 January 11, 1996 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lifecore Biomedical, Inc. devices

Submission Details

510(k) Number K954819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1995
Decision Date January 11, 1996
Days to Decision 83 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 faster than avg
Panel avg: 127d · This submission: 83d
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 673
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K954819.
3I HYDROXYLAPATITE COATED STANDARD THREADED & SELF-TAPPING IMPLANTS
K955428 · Implant Innovations, Inc. · Feb 1996
ABUTMENT RETRIEVAL KIT
K955697 · Nobelpharma USA, Inc. · Jan 1996
BALL ATTACHMENT SYSTEM
K955372 · Nobelpharma USA, Inc. · Jan 1996
RESTORE HA DENTAL IMPLANT SYSTEM
K954865 · Lifecore Biomedical, Inc. · Jan 1996
STERI-OSS IMMEDIATE PLACEMENT IMPLANT
K952917 · Steri-Oss, Inc. · Oct 1995
BRANEMARK RADIOGRAPHIC DEPTH GUAGE
K953435 · Nobelpharma USA, Inc. · Oct 1995