Cleared Traditional

K930155 - MINIBALL ABUTMENT

K930155 is an FDA 510(k) clearance for MINIBALL ABUTMENT, 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 397-day FDA review.

K930155 · Steri-Oss, Inc. · Dental device
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Feb 1994
Decision
397d
Days
Class 2
Risk

K930155 is an FDA 510(k) clearance for the MINIBALL ABUTMENT. 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 February 14, 1994 after a review of 397 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K930155

510(k) Number K930155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1993
Decision Date February 14, 1994
Days to Decision 397 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
270d slower than avg
Panel avg: 127d · This submission: 397d
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 K930155.
ONE AND TWO PIECE TEMPORARY HEALING,(EMERGENCE PROFILE) ABUTMENTS
K934126 · Implant Innovations, Inc. · Apr 1994
STRYKER PRECISION DENTAL IMPLANT SYSTEM
K921805 · Stryker Instruments · Mar 1994
CONICAL ABUTMENT
K933462 · Implant Innovations, Inc. · Mar 1994
BRANEMARK SYSTEM INTERLOCKING ABUTMENT/GOLD CYLIND
K925776 · Nobelpharma USA, Inc. · Feb 1994
ASTRA TECH IMPLANTS-DENTAL SYSTEM
K931767 · Astra Tech, Inc. · Feb 1994
HA-BIONTEGRATED DENTAL IMPLANT SYSTEMS
K914137 · Lifecore Biomedical, Inc. · Feb 1994