Cleared Traditional

K954539 - LG HEX PROSTHETICS

K954539 is an FDA 510(k) clearance for LG HEX PROSTHETICS, manufactured by The Implant Center of the Palm Beaches. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K954539 · The Implant Center of the Palm Beaches · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
52d
Days
Class 2
Risk

K954539 is an FDA 510(k) clearance for the LG HEX PROSTHETICS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by The Implant Center of the Palm Beaches (N. Palm Beach, US). The FDA issued a Cleared decision on October 30, 1995 after a review of 52 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 The Implant Center of the Palm Beaches devices

FDA 510(k) Submission Details - K954539

510(k) Number K954539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1995
Decision Date October 30, 1995
Days to Decision 52 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
75d faster than avg
Panel avg: 127d · This submission: 52d
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 941
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K954539.
UNCOATED SCREW IMPLANT 3.75, 4.0-B5
K952999 · Implant Center of the Palm Beaches · Oct 1995
WIDE SYSTEM SCREW B5 UNCOATED 5MM, 6MM
K953000 · Implant Center of the Palm Beaches · Oct 1995
TP-4K SCREW IMPLANT 3.3, 3.75, 4.0
K953001 · Implant Center of the Palm Beaches · Oct 1995
STERI-OSS IMMEDIATE PLACEMENT IMPLANT
K952917 · Steri-Oss, Inc. · Oct 1995
INTEGRAL VII 3.25MM BIOINTEGRATED DENTAL IMPLANT SYSTEM
K946311 · Calcitek, Inc. · Oct 1995
BRANEMARK RADIOGRAPHIC DEPTH GUAGE
K953435 · Nobelpharma USA, Inc. · Oct 1995