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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 128d · 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 1483
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K072363.
BIOHORIZONS INTERNAL IMPLANT SYSTEM
K073268 · BioHorizons Implant Systems, Inc. · Feb 2008
ATLAS IMPLANT SYSTEM
K071148 · Cowellmedi Co., Ltd. · Feb 2008
MS SYSTEM (DENTURE)
K072959 · Osstem Implant Co., Ltd. · Feb 2008
IMPLASA-HOECHST GMBH IMPLANTS
K071240 · Implasa-Hoechst GmbH · Jan 2008
JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM
K072917 · Odontit S.A. · Jan 2008
NOBELREPLACE HEXAGONAL IMPLANT
K073142 · Nobel Biocare USA, LLC · Jan 2008
K072363 · NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX
Download PDF FDA Summary Biomet 3i, Inc.