Cleared Traditional

K953000 - WIDE SYSTEM SCREW B5 UNCOATED 5MM, 6MM

K953000 is an FDA 510(k) clearance for WIDE SYSTEM SCREW B5 UNCOATED 5MM, manufactured by 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 130-day FDA review.

K953000 · Implant Center of the Palm Beaches · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
130d
Days
Class 2
Risk

K953000 is an FDA 510(k) clearance for the WIDE SYSTEM SCREW B5 UNCOATED 5MM, 6MM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Implant Center of the Palm Beaches (N. Palm Beach, US). The FDA issued a Cleared decision on October 31, 1995 after a review of 130 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Implant Center of the Palm Beaches devices

FDA 510(k) Submission Details - K953000

510(k) Number K953000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1995
Decision Date October 31, 1995
Days to Decision 130 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 127d · This submission: 130d
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 868
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K953000.
PRE ANGULATED PROSTH: 15 DEG ANGLED, 25,& 25 CONE ANGLED
K952997 · Implant Center of the Palm Beaches · Oct 1995
TP SCREW IMPLANT 3.75, 4.0-B5
K952998 · Implant Center of the Palm Beaches · Oct 1995
UNCOATED SCREW IMPLANT 3.75, 4.0-B5
K952999 · 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