Cleared Traditional

SMOOTH STAPLE IMPLANT (K900433) - FDA 510(k) Clearance

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

K900433 · Interphase Implants, Inc. · Dental device
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Nov 1990
Decision
290d
Days
Class 2
Risk

K900433 is an FDA 510(k) clearance for the SMOOTH STAPLE IMPLANT. Classified as Implant, Transmandibular (product code MDL), Class II - Special Controls.

Submitted by Interphase Implants, Inc. (Livonia, US). The FDA issued a Cleared decision on November 16, 1990 after a review of 290 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - 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 Interphase Implants, Inc. devices

Submission Details

510(k) Number K900433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received January 30, 1990
Decision Date November 16, 1990
Days to Decision 290 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 127d · This submission: 290d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MDL Implant, Transmandibular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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.