Cleared Traditional

K901958 - GUARDIAN SAFE BOW

K901958 is an FDA 510(k) clearance for GUARDIAN SAFE BOW, manufactured by Lancer Orthodontics, Inc.. The device is a Class 2 Dental device with product code DZB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K901958 · Lancer Orthodontics, Inc. · Dental device
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Jul 1990
Decision
90d
Days
Class 2
Risk

K901958 is an FDA 510(k) clearance for the GUARDIAN SAFE BOW. Classified as Headgear, Extraoral, Orthodontic (product code DZB), Class II - Special Controls.

Submitted by Lancer Orthodontics, Inc. (Carlsbad, US). The FDA issued a Cleared decision on July 30, 1990 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5500 - 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 - K901958

510(k) Number K901958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1990
Decision Date July 30, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZB Device Classification - Class 2, Special Controls

Product Code DZB Headgear, Extraoral, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5500
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.