Cleared Traditional

K991488 - SELF CURE COMPOSITE

K991488 is an FDA 510(k) clearance for SELF CURE COMPOSITE, manufactured by Harry J. Bosworth Co.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K991488 · Harry J. Bosworth Co. · Dental device
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Jun 1999
Decision
54d
Days
Class 2
Risk

K991488 is an FDA 510(k) clearance for the SELF CURE COMPOSITE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Harry J. Bosworth Co. (Skokie, US). The FDA issued a Cleared decision on June 21, 1999 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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

FDA 510(k) Submission Details - K991488

510(k) Number K991488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1999
Decision Date June 21, 1999
Days to Decision 54 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 127d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 758
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K991488.
PRODIGY 4 TRANSLUCENT SHADES
K992118 · Sybron Dental Specialties, Inc. · Aug 1999
3M LVR SYSTEM
K991961 · 3M Company · Aug 1999
ETCHING GEL
K991450 · Silicon-Und Composite Spezialitaten GmbH · Jul 1999
FLC COMPOSITE
K991491 · Harry J. Bosworth Co. · Jun 1999
LC MICROFILL
K991442 · S & C Polymer GmbH · Jun 1999
FLOW LINE
K990756 · Heraeus Kulzer, Inc. · May 1999