Cleared Traditional

SCREW IMPLANTS, GRADE 3 (K953234) - FDA 510(k) Clearance

Also marketed or referenced as:
UNCOATED, HA, TP-B3

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K953234 · The Implant Center of the Palm Beaches · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
120d
Days
Class 2
Risk

K953234 is an FDA 510(k) clearance for the SCREW IMPLANTS, GRADE 3. 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 November 8, 1995 after a review of 120 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 The Implant Center of the Palm Beaches devices

Submission Details

510(k) Number K953234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1995
Decision Date November 08, 1995
Days to Decision 120 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
7d faster than avg
Panel avg: 127d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 303
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