Cleared Traditional

K885158 - MENSOR COMPLIANT KEEPER

K885158 is an FDA 510(k) clearance for MENSOR COMPLIANT KEEPER, manufactured by Merrill C. Mensor, Jr., D.D.S.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 905-day FDA review.

K885158 · Merrill C. Mensor, Jr., D.D.S. · Dental device
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Jun 1991
Decision
905d
Days
Class 2
Risk

K885158 is an FDA 510(k) clearance for the MENSOR COMPLIANT KEEPER. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Merrill C. Mensor, Jr., D.D.S. (Truckee, US). The FDA issued a Cleared decision on June 6, 1991 after a review of 905 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Merrill C. Mensor, Jr., D.D.S. devices

FDA 510(k) Submission Details - K885158

510(k) Number K885158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1988
Decision Date June 06, 1991
Days to Decision 905 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
778d slower than avg
Panel avg: 127d · This submission: 905d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

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 1328
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