Cleared Traditional

K960398 - STERI-OSS APICAL IMPLANT

K960398 is an FDA 510(k) clearance for STERI-OSS 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 185-day FDA review.

K960398 · Steri-Oss, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
185d
Days
Class 2
Risk

K960398 is an FDA 510(k) clearance for the STERI-OSS 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 August 1, 1996 after a review of 185 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 Steri-Oss, Inc. devices

FDA 510(k) Submission Details - K960398

510(k) Number K960398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1996
Decision Date August 01, 1996
Days to Decision 185 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
58d slower than avg
Panel avg: 127d · This submission: 185d
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 K960398.
TIL313 ABUTMENT AND RETAINING SCREW SYSTEMS
K962465 · Implant Innovations, Inc. · Sep 1996
NOBLEPHARMA WIDE ACCESSORIES
K962403 · Nobelpharma USA, Inc. · Sep 1996
OSTEO COMPACTION KIT
K962449 · Steri-Oss, Inc. · Sep 1996
3I STND THREADED/SELF TAPPING THREADED/3I MINIPLANT IMPLANTS/3 I EMERGENCE PROF. TEMP. HEALING ABUTMENTS
K960417 · Implant Innovations, Inc. · Aug 1996
STERI-OSS 6 MM DIAMETER HA COATED IMPLANTS
K960886 · Steri-Oss, Inc. · Aug 1996
BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE
K962130 · Nobelpharma USA, Inc. · Jul 1996