Cleared Traditional

K071192 - BLUGOO HD

K071192 is the FDA 510(k) clearance for BLUGOO HD by Lancer Orthodontics, Inc.. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K071192 · Lancer Orthodontics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
53d
Days
Class 2
Risk

K071192 is an FDA 510(k) clearance for the BLUGOO HD. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Lancer Orthodontics, Inc. (Irvine, US). The FDA issued a Cleared decision on June 22, 2007 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lancer Orthodontics, Inc. devices

Submission Details

510(k) Number K071192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2007
Decision Date June 22, 2007
Days to Decision 53 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
74d faster than avg
Panel avg: 127d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 128
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