Cleared Traditional

K951239 - GLOWING SPIRITS

K951239 is an FDA 510(k) clearance for GLOWING SPIRITS, manufactured by Ormco Corp.. The device is a Class 2 Dental device with product code DYW cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K951239 · Ormco Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
121d
Days
Class 2
Risk

K951239 is an FDA 510(k) clearance for the GLOWING SPIRITS. Classified as Bracket, Plastic, Orthodontic (product code DYW), Class II - Special Controls.

Submitted by Ormco Corp. (Glendora, US). The FDA issued a Cleared decision on July 19, 1995 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - 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 Ormco Corp. devices

FDA 510(k) Submission Details - K951239

510(k) Number K951239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1995
Decision Date July 19, 1995
Days to Decision 121 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
6d faster than avg
Panel avg: 127d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYW Device Classification - Class 2, Special Controls

Product Code DYW Bracket, Plastic, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
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 - DYW Bracket, Plastic, Orthodontic

All 25
Devices cleared under the same product code (DYW) and FDA review panel - the closest regulatory comparables to K951239.
ORTHODONTIC BRACES
K981433 · Midwest Orthodontic Mfg. · Jun 1998
REFLECTIONS
K973776 · Cdb Corp. · Nov 1997
SPIRIT MB
K955333 · Ormco Corp. · Jan 1996
METAL-LINED TRANSCEND CERAMIC BRACKET
K944286 · Unitek Corp. · Nov 1994
SPIRIT MB
K943245 · Sybron Dental Specialties, Inc. · Aug 1994
LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS
K900809 · Lee Pharmaceuticals · Jun 1990