Cleared Traditional

K953237 - PROSTHETICS & INSTRUMENTATION A. PROSTHETIC ABUTMENTS 4, 5, 6 DIAMETER, GRADE 3, B. IRRIGATION DRILLS, TOOLING & PREANG'

K953237 is an FDA 510(k) clearance for PROSTHETICS & INSTRUMENTATION A. PROSTH..., 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 66-day FDA review.

K953237 · The Implant Center of the Palm Beaches · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
66d
Days
Class 2
Risk

K953237 is an FDA 510(k) clearance for the PROSTHETICS & INSTRUMENTATION A. PROSTHETIC ABUTMENTS 4, 5, 6 DIAMETER, GRADE.... 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 September 15, 1995 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 The Implant Center of the Palm Beaches devices

FDA 510(k) Submission Details - K953237

510(k) Number K953237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1995
Decision Date September 15, 1995
Days to Decision 66 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
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 941
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K953237.
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DENTAL IMPLANT ENDOSSEOUS
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HA, TP CYLINDER, UNIHOLE
K953280 · Implant Center of the Palm Beaches · Sep 1995
HA, TP CYLINDER OVAL
K953281 · Implant Center of the Palm Beaches · Sep 1995
KIS-- FOUR HOLE CYLINDER
K953139 · Implant Center of the Palm Beaches · Sep 1995