Cleared Traditional

K944158 - STERI-OSS TITANIUM ALLOY SCREW SERIES I...

K944158 is an FDA 510(k) clearance for STERI-OSS TITANIUM ALLOY SCREW SERIES I..., 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 215-day FDA review.

K944158 · Steri-Oss, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
215d
Days
Class 2
Risk

K944158 is an FDA 510(k) clearance for the STERI-OSS TITANIUM ALLOY SCREW SERIES IMPLANT FOR SINGLE STAGE SURGICAL PLACE.... 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 March 29, 1995 after a review of 215 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 - K944158

510(k) Number K944158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1994
Decision Date March 29, 1995
Days to Decision 215 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 127d · This submission: 215d
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 K944158.
STERI-OSS SCALER FOR DENTAL IMPLANTS
K943681 · Steri-Oss, Inc. · Apr 1995
BRANEMARK SYSTEM(R) MKII SELF-TAPPING FIXTURE
K945398 · Nobelpharma USA, Inc. · Apr 1995
RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM)
K951111 · Lifecore Biomedical, Inc. · Mar 1995
BRANEMARK SYSTEM 3.3MM FIXTURE
K944683 · Nobelpharma USA, Inc. · Mar 1995
RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEM
K944069 · Lifecore Biomedical, Inc. · Feb 1995
BRANEMARK SYSTEM MIRUSCONE ABUTMENT SYSTEM
K944964 · Nobelpharma USA, Inc. · Feb 1995