Cleared Traditional

K960288 - HA & TPS RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM

K960288 is an FDA 510(k) clearance for HA & TPS RESTORE SELF TAPPING DENTAL IM..., 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 66-day FDA review.

K960288 · Lifecore Biomedical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
66d
Days
Class 2
Risk

K960288 is an FDA 510(k) clearance for the HA & 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 March 28, 1996 after a review of 66 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 - K960288

510(k) Number K960288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1996
Decision Date March 28, 1996
Days to Decision 66 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
61d faster than avg
Panel avg: 127d · This submission: 66d
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 1267
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K960288.
SARGON IMMEDIATE LOAD IMPLANT
K961005 · Graham & James · May 1996
3I STANDARD THREADED IMPLANT
K954347 · Implant Innovations, Inc. · Apr 1996
BIOHORIZONS DENTAL IMPLANT SYSTEM
K960026 · BioHorizons Implant Systems, Inc. · Mar 1996
KIS MT4
K960111 · The Implant Center of the Palm Beaches · Mar 1996
KIS MT3
K960110 · The Implant Center of the Palm Beaches · Mar 1996
FRIALIT(R)-2 STEPPED SCREW WITH DEEP PROFILE SURFACE
K945847 · Friatec Medical Inc., USA · Mar 1996