Cleared Traditional

K900433 - SMOOTH STAPLE IMPLANT

K900433 is an FDA 510(k) clearance for SMOOTH STAPLE IMPLANT, manufactured by Interphase Implants, Inc.. The device is a Class 2 Dental device with product code MDL cleared through the Traditional 510(k) pathway after a 290-day FDA review.

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

FDA 510(k) Submission Details - K900433

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.

MDL Device Classification - Class 2, Special Controls

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.