Cleared Traditional

K955427 - 3I TITANIUM PLASMA SPRAYED STANDARD THREADED & SELF-TAPPING IMPLANTS

K955427 is an FDA 510(k) clearance for 3I TITANIUM PLASMA SPRAYED STANDARD THR..., manufactured by Implant Innovations, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K955427 · Implant Innovations, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
73d
Days
Class 2
Risk

K955427 is an FDA 510(k) clearance for the 3I TITANIUM PLASMA SPRAYED STANDARD THREADED & SELF-TAPPING IMPLANTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Implant Innovations, Inc. (West Palm Baeach, US). The FDA issued a Cleared decision on February 9, 1996 after a review of 73 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 Implant Innovations, Inc. devices

FDA 510(k) Submission Details - K955427

510(k) Number K955427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1995
Decision Date February 09, 1996
Days to Decision 73 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 127d · This submission: 73d
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 1186
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K955427.
INTERPORE THREADED IMPLANT
K960371 · Interpore Intl. · Mar 1996
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K931647 · Vancouver Implant Center · Mar 1996
RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM
K954512 · Lifecore Biomedical, Inc. · Feb 1996
INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM
K943604 · Calcitek, Inc. · Feb 1996
3I HYDROXYLAPATITE COATED STANDARD THREADED & SELF-TAPPING IMPLANTS
K955428 · Implant Innovations, Inc. · Feb 1996
CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMS
K960021 · Calcitek, Inc. · Feb 1996