Cleared Traditional

K963401 - TPS APICAL IMPLANT

K963401 is an FDA 510(k) clearance for TPS APICAL IMPLANT, manufactured by Steri-Oss, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K963401 · Steri-Oss, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
68d
Days
Class 2
Risk

K963401 is an FDA 510(k) clearance for the TPS APICAL IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Steri-Oss, Inc. (Yorba Linda, US). The FDA issued a Cleared decision on November 5, 1996 after a review of 68 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 Steri-Oss, Inc. devices

FDA 510(k) Submission Details - K963401

510(k) Number K963401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1996
Decision Date November 05, 1996
Days to Decision 68 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
59d faster than avg
Panel avg: 127d · This submission: 68d
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 698
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K963401.
AS 123 PROSTHETIC INSTRUMENTATION SYSTEM
K963951 · BioHorizons Implant Systems, Inc. · Dec 1996
STERI-OSS IMPLANTS FOR SINGLE STAGE PLACEMENT
K963224 · Steri-Oss, Inc. · Nov 1996
FIXTURE MOUNT KIT
K963121 · Steri-Oss, Inc. · Nov 1996
3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC.
K962014 · Implant Innovations, Inc. · Oct 1996
REPLACE TPS COATED IMPLANTS
K962844 · Steri-Oss, Inc. · Oct 1996
REPLACE HA COATED IMPLANTS
K962845 · Steri-Oss, Inc. · Oct 1996