Cleared Traditional

K051552 - O.A.S.I. SYSTEM

K051552 is an FDA 510(k) clearance for O.A.S.I. SYSTEM, manufactured by Lancer Orthodontics, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K051552 · Lancer Orthodontics, Inc. · Dental device
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Sep 2005
Decision
98d
Days
Class 2
Risk

K051552 is an FDA 510(k) clearance for the O.A.S.I. SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Lancer Orthodontics, Inc. (Irvine, US). The FDA issued a Cleared decision on September 19, 2005 after a review of 98 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 Lancer Orthodontics, Inc. devices

FDA 510(k) Submission Details - K051552

510(k) Number K051552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2005
Decision Date September 19, 2005
Days to Decision 98 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
29d faster than avg
Panel avg: 127d · This submission: 98d
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 1186
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K051552.
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INTERMEZZO IMPLANT SYSTEMS
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