Cleared Traditional

K791204 - MITER ENDOSTEAL BLADE IMPLANT (FDA 510(k) Clearance)

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

K791204 · Depuy, Inc. · Dental device
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Sep 1979
Decision
92d
Days
Class 2
Risk

K791204 is an FDA 510(k) clearance for the MITER ENDOSTEAL BLADE IMPLANT. Classified as Blade-form Endosseous Dental Implant (product code NRQ), Class II - Special Controls.

Submitted by Depuy, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 28, 1979 after a review of 92 days - within the typical 510(k) review window.

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 Depuy, Inc. devices

Submission Details

510(k) Number K791204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1979
Decision Date September 28, 1979
Days to Decision 92 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 127d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NRQ Blade-form Endosseous Dental Implant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
Definition Device Made Of A Material Such As Titanium Or Titanium Alloy, That Is Intended To Be Surgically Placed In The Bone Of The Upper Or Lower Jaw Arches To Provide Support For Prosthetic Devices, Such As Artificial Teeth, In Order To Restore A Patient's Chewing Function.
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.