Cleared Traditional

K041886 - PROVISO

K041886 is the FDA 510(k) clearance for PROVISO by Scientific Pharmaceuticals, Inc.. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K041886 · Scientific Pharmaceuticals, Inc. · Dental device
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Aug 2004
Decision
23d
Days
Class 2
Risk

K041886 is an FDA 510(k) clearance for the PROVISO. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Scientific Pharmaceuticals, Inc. (Pomona, US). The FDA issued a Cleared decision on August 4, 2004 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 Scientific Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K041886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2004
Decision Date August 04, 2004
Days to Decision 23 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
104d faster than avg
Panel avg: 127d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 98
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K041886.
TEMPFX ESTHETIC PROVISIONAL SYSTEM
K061264 · Dentsply International, Inc. · May 2006
TEMPORARY CROWN AND BRIDGE MATERIAL
K060293 · Dentsply International, Inc. · Feb 2006
SYSTEMP.C&B PLUS
K042820 · Ivoclar Vivadent, Inc. · Dec 2004
SR ADORO
K040951 · Ivoclar Vivadent, Inc. · May 2004
STRUCTUR 2 SC
K040769 · Voco GmbH · Apr 2004
FILL-IN
K031476 · Sybron Dental Specialties, Inc. · Jul 2003