Cleared Traditional

K954819 - RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEM

K954819 is an FDA 510(k) clearance for RESTORE TPS DENTAL IMPLANT SYSTEM SUSTA..., 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 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

FDA 510(k) Submission Details - K954819

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.

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 1265
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K954819.
INTERPORE IMZ CYL IMPLANT & CYL HEX IMPLT
K955492 · Interpore Intl. · Jan 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
KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM
K955048 · The Implant Center of the Palm Beaches · Jan 1996
CAL-FORM DENTAL IMPLANTS
K933646 · Cal-Form, Inc. · Jan 1996