Cleared Traditional

K960979 - SCREW EXTRACTION DEVICE AND THREAD CLEA...

K960979 is an FDA 510(k) clearance for SCREW EXTRACTION DEVICE AND THREAD CLEA..., 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 70-day FDA review.

K960979 · Steri-Oss, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
70d
Days
Class 2
Risk

K960979 is an FDA 510(k) clearance for the SCREW EXTRACTION DEVICE AND THREAD CLEANING TAP. 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 May 20, 1996 after a review of 70 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 - K960979

510(k) Number K960979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1996
Decision Date May 20, 1996
Days to Decision 70 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
57d faster than avg
Panel avg: 127d · This submission: 70d
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
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