Cleared Traditional

K072363 - NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX

K072363 is an FDA 510(k) clearance for NANOTITE PREVAIL, manufactured by Biomet 3i, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K072363 · Biomet 3i, Inc. · Dental device
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Jan 2008
Decision
161d
Days
Class 2
Risk

K072363 is an FDA 510(k) clearance for the NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Biomet 3i, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on January 31, 2008 after a review of 161 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 3i, Inc. devices

FDA 510(k) Submission Details - K072363

510(k) Number K072363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2007
Decision Date January 31, 2008
Days to Decision 161 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 127d · This submission: 161d
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 892
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K072363.
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MS SYSTEM (DENTURE)
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MS SYSTEM (PROVISIONAL)
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NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM
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K072980 · Nobel Biocare AB · Dec 2007