Cleared Traditional

K911592 - STERI-OSS TITANIUM PLAMA SPRAY CYLINDRI...

K911592 is an FDA 510(k) clearance for STERI-OSS TITANIUM PLAMA SPRAY CYLINDRI..., 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 835-day FDA review.

K911592 · Steri-Oss, Inc. · Dental device
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Jul 1993
Decision
835d
Days
Class 2
Risk

K911592 is an FDA 510(k) clearance for the STERI-OSS TITANIUM PLAMA SPRAY CYLINDRICAL IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Steri-Oss, Inc. (Anaheim, US). The FDA issued a Cleared decision on July 22, 1993 after a review of 835 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Steri-Oss, Inc. devices

FDA 510(k) Submission Details - K911592

510(k) Number K911592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1991
Decision Date July 22, 1993
Days to Decision 835 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
708d slower than avg
Panel avg: 127d · This submission: 835d
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 K911592.
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K925771 · Nobelpharma USA, Inc. · Apr 1993