Cleared Traditional

K990699 - ORTHO-GLOW GLITTER

K990699 is the FDA 510(k) clearance for ORTHO-GLOW GLITTER by Harry J. Bosworth Co.. It is a Class 2 Dental device (product code EBI) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K990699 · Harry J. Bosworth Co. · Dental device
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May 1999
Decision
75d
Days
Class 2
Risk

K990699 is an FDA 510(k) clearance for the ORTHO-GLOW GLITTER. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Harry J. Bosworth Co. (Skokie, US). The FDA issued a Cleared decision on May 17, 1999 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 Harry J. Bosworth Co. devices

Submission Details

510(k) Number K990699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1999
Decision Date May 17, 1999
Days to Decision 75 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 127d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 129
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K990699.
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K990056 · J.F. Jelenko & Co., Inc. · Mar 1999
GC UNIFAST TRAD
K984365 · GC America, Inc. · Feb 1999
GC RELINE
K982695 · GC America, Inc. · Oct 1998