Cleared Traditional

KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS) (K962753) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K962753 · Biomedical Implant Technology, Inc. · Dental device
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May 1997
Decision
308d
Days
Class 2
Risk

K962753 is an FDA 510(k) clearance for the KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS). Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Biomedical Implant Technology, Inc. (Boca Raton, US). The FDA issued a Cleared decision on May 19, 1997 after a review of 308 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 Biomedical Implant Technology, Inc. devices

Submission Details

510(k) Number K962753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1996
Decision Date May 19, 1997
Days to Decision 308 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 127d · This submission: 308d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 303
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