Cleared Traditional

K941849 - PROVIPONT C&B

K941849 is an FDA 510(k) clearance for PROVIPONT C&B, manufactured by Ivoclar USA, Inc.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K941849 · Ivoclar USA, Inc. · Dental device
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Aug 1994
Decision
125d
Days
Class 2
Risk

K941849 is an FDA 510(k) clearance for the PROVIPONT C&B. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Ivoclar USA, Inc. (Amherst, US). The FDA issued a Cleared decision on August 17, 1994 after a review of 125 days - within the typical 510(k) review window.

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: 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 Ivoclar USA, Inc. devices

FDA 510(k) Submission Details - K941849

510(k) Number K941849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1994
Decision Date August 17, 1994
Days to Decision 125 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
2d faster than avg
Panel avg: 127d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

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 159
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K941849.
PROTEMP(R) GARANT
K950203 · Espe GmbH & Co. Kg. · Feb 1995
3M TEMPCARE LIGHT CURE TEMPORARY SYSTEM
K944981 · 3M Company · Dec 1994
GC PATTERN RESIN
K942670 · GC America, Inc. · Oct 1994
STRUCTUR 2
K941124 · Voco GmbH · Apr 1994
GC TEMPRON
K935960 · GC America, Inc. · Mar 1994
3M TEMPORARY CROWN & BRIDGE MATERIAL
K935041 · 3M Company · Jan 1994