Cleared Traditional

K965032 - THE PERIOSEAL DENTAL IMPLANT

K965032 is an FDA 510(k) clearance for THE PERIOSEAL DENTAL IMPLANT, manufactured by Perioseal. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K965032 · Perioseal · Dental device
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Aug 1997
Decision
246d
Days
Class 2
Risk

K965032 is an FDA 510(k) clearance for the THE PERIOSEAL DENTAL IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Perioseal (Little Rock, US). The FDA issued a Cleared decision on August 20, 1997 after a review of 246 days - an extended review 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: 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 Perioseal devices

FDA 510(k) Submission Details - K965032

510(k) Number K965032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1996
Decision Date August 20, 1997
Days to Decision 246 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 127d · This submission: 246d
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 940
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K965032.
THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM
K972417 · Bicon, Inc. · Sep 1997
THE MAESTRO SYSTEM
K972313 · BioHorizons Implant Systems, Inc. · Sep 1997
3I INNOVATIVE IMPLANTS AND COVER SCREWS
K972444 · Implant Innovations, Inc. · Aug 1997
BICON DENTAL IMPLANTS II PART ABUTMENT SYSTEM
K972029 · Bicon, Inc. · Aug 1997
ENDOSSEOUS DENTAL IMPLANT
K971578 · Straumann USA · Jun 1997
EDOSSEOUS DENTAL IMPLANT
K970127 · Sulzer Calcitek, Inc. · Jun 1997