Cleared Traditional

K901552 - (CP) TITANIUM AND TI6AI-4V ALLOY FOR FI...

K901552 is the FDA 510(k) clearance for (CP) TITANIUM AND TI6AI-4V ALLOY FOR FI... by Nobelpharma USA, Inc.. It is a Class 2 Dental device (product code EJH) cleared through the Traditional 510(k) pathway after a 447-day FDA review.

K901552 · Nobelpharma USA, Inc. · Dental device
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Jun 1991
Decision
447d
Days
Class 2
Risk

K901552 is an FDA 510(k) clearance for the (CP) TITANIUM AND TI6AI-4V ALLOY FOR FIXED PROSTHE. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Nobelpharma USA, Inc. (Chicago, US). The FDA issued a Cleared decision on June 24, 1991 after a review of 447 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3710 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Nobelpharma USA, Inc. devices

Submission Details

510(k) Number K901552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1990
Decision Date June 24, 1991
Days to Decision 447 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
320d slower than avg
Panel avg: 127d · This submission: 447d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJH Alloy, Metal, Base
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3710
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 - EJH Alloy, Metal, Base

All 36
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K901552.
DEGUCAST 40
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TECH STAR DENTAL CASTING ALLOYS (NON-PRECIOUS)
K896501 · Leach and Dillon Co., Inc. · Feb 1990