Cleared Traditional

K953331 - COMBINATION KIT

K953331 is an FDA 510(k) clearance for COMBINATION KIT, 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 53-day FDA review.

K953331 · Steri-Oss, Inc. · Dental device
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Sep 1995
Decision
53d
Days
Class 2
Risk

K953331 is an FDA 510(k) clearance for the COMBINATION KIT. 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 September 8, 1995 after a review of 53 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 - K953331

510(k) Number K953331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1995
Decision Date September 08, 1995
Days to Decision 53 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
74d faster than avg
Panel avg: 127d · This submission: 53d
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 K953331.
ABUTMENT
K953836 · Steri-Oss, Inc. · Sep 1995
BRANEMARK SYSTEM DRILLS AND COUNTERSINKS
K952685 · Nobelpharma USA, Inc. · Sep 1995
BRANEMARK SYSTEM OVOID & U-SHAPED BAR SYSTEM
K952886 · Nobelpharma USA, Inc. · Sep 1995
LABORATORY SUPPLIES
K953380 · Steri-Oss, Inc. · Sep 1995
HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM
K950624 · Lifecore Biomedical, Inc. · Aug 1995
LAPPING TOOL KIT
K953103 · Steri-Oss, Inc. · Aug 1995