Cleared Traditional

DPI-1106 IMPLANT, MODIFICATION (K911776) - FDA 510(k) Clearance

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

K911776 · Minimatic Implant Technology · Dental device
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Jan 1992
Decision
289d
Days
Class 2
Risk

K911776 is an FDA 510(k) clearance for the DPI-1106 IMPLANT, MODIFICATION. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Minimatic Implant Technology (Deerfield Beach, US). The FDA issued a Cleared decision on January 15, 1992 after a review of 289 days - an extended review 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: 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 Minimatic Implant Technology devices

Submission Details

510(k) Number K911776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1991
Decision Date January 15, 1992
Days to Decision 289 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 127d · This submission: 289d
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.