Cleared Traditional

K900809 - LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS

K900809 is an FDA 510(k) clearance for LEE-FISCHER CERAMIC REINFORCED PLASTIC ..., manufactured by Lee Pharmaceuticals. The device is a Class 2 Dental device with product code DYW cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K900809 · Lee Pharmaceuticals · Dental device
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Jun 1990
Decision
127d
Days
Class 2
Risk

K900809 is an FDA 510(k) clearance for the LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS. Classified as Bracket, Plastic, Orthodontic (product code DYW), Class II - Special Controls.

Submitted by Lee Pharmaceuticals (South El Monte, US). The FDA issued a Cleared decision on June 28, 1990 after a review of 127 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 Lee Pharmaceuticals devices

FDA 510(k) Submission Details - K900809

510(k) Number K900809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1990
Decision Date June 28, 1990
Days to Decision 127 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 127d · This submission: 127d
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 36
Devices cleared under the same product code (DYW) and FDA review panel - the closest regulatory comparables to K900809.
GLOWING SPIRITS
K951239 · Ormco Corp. · Jul 1995
METAL-LINED TRANSCEND CERAMIC BRACKET
K944286 · Unitek Corp. · Nov 1994
SPIRIT MB
K943245 · Sybron Dental Specialties, Inc. · Aug 1994
SPIRIT
K896913 · Ormco Corp. · Mar 1990
ORTHODONTIC PLASTIC BRACKET
K891372 · American Orthodontics · Mar 1989
UNITEK CERAMIC BRACKET SYSTEM
K861965 · Unitek Corp. · Jun 1986