Cleared Traditional

K941620 - LORENZ SURGICAL CYLINDER DENTAL IMPLANT

K941620 is the FDA 510(k) clearance for LORENZ SURGICAL CYLINDER DENTAL IMPLANT by Biomet, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K941620 · Biomet, Inc. · Dental device
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Sep 1994
Decision
178d
Days
Class 2
Risk

K941620 is an FDA 510(k) clearance for the LORENZ SURGICAL CYLINDER DENTAL IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 29, 1994 after a review of 178 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 Biomet, Inc. devices

Submission Details

510(k) Number K941620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1994
Decision Date September 29, 1994
Days to Decision 178 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 127d · This submission: 178d
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.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 645
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K941620.
IMPAC TORQUE WRENCH
K940998 · Vident · Nov 1994
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K941247 · Vident · Nov 1994
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K941619 · Biomet, Inc. · Sep 1994
LORENZ SURGICAL FINNED DENTAL IMPLANT
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K925481 · Steri-Oss, Inc. · Sep 1994
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K925555 · Steri-Oss, Inc. · Sep 1994