Cleared Traditional

K973402 - STERI-OSS 3.25 MM REPLACE DENTAL IMPLAN...

K973402 is an FDA 510(k) clearance for STERI-OSS 3.25 MM REPLACE DENTAL IMPLAN..., 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 78-day FDA review.

K973402 · Steri-Oss, Inc. · Dental device
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Nov 1997
Decision
78d
Days
Class 2
Risk

K973402 is an FDA 510(k) clearance for the STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEM. 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 26, 1997 after a review of 78 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 - K973402

510(k) Number K973402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1997
Decision Date November 26, 1997
Days to Decision 78 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
49d faster than avg
Panel avg: 127d · This submission: 78d
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 K973402.
STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT
K973433 · Steri-Oss, Inc. · Dec 1997
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K973771 · Implant Innovations, Inc. · Dec 1997
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K973353 · Straumann USA · Dec 1997
BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM
K970499 · Nobel Biocare Uas, Inc. · Oct 1997
THE MAESTRO SYSTEM
K972313 · BioHorizons Implant Systems, Inc. · Sep 1997
3I INNOVATIVE IMPLANTS AND COVER SCREWS
K972444 · Implant Innovations, Inc. · Aug 1997