Cleared Traditional

K902040 - ALTIS (RESIN, CROWN AND BRIDGES)

K902040 is an FDA 510(k) clearance for ALTIS (RESIN, manufactured by Pb2 Investment, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K902040 · Pb2 Investment, Inc. · Dental device
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Oct 1990
Decision
158d
Days
Class 2
Risk

K902040 is an FDA 510(k) clearance for the ALTIS (RESIN, CROWN AND BRIDGES). Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Pb2 Investment, Inc. (Houston, US). The FDA issued a Cleared decision on October 9, 1990 after a review of 158 days - an extended review 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: 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 Pb2 Investment, Inc. devices

FDA 510(k) Submission Details - K902040

510(k) Number K902040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1990
Decision Date October 09, 1990
Days to Decision 158 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 127d · This submission: 158d
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 816
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K902040.
SPECIAL BOND II
K905221 · Ivoclar North America, Inc. · Dec 1990
DURAFILL FLOW
K904555 · Kulzer, Inc. · Nov 1990
CORADENT
K901260 · Ivoclar North America, Inc. · Oct 1990
HELIOLINK TRY-IN PASTES
K903587 · Ivoclar North America, Inc. · Oct 1990
TEMPOREX
K903551 · Scientific Pharmaceuticals, Inc. · Oct 1990
TI-CORE (DENTAL COMPOSITE)
K902893 · Medical Device Inspection Co., Inc. · Sep 1990