Cleared Traditional

K034049 - HERADOR EC, PF, C, H, NH, G, GG AND MP (FDA 510(k) Clearance)

Also includes:
HERALOY U AND G HERABOND N ALBABOND C, B AND A BIO HERANORM

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K034049 · Heraeus Kulzer,GmbH · Dental device
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Mar 2004
Decision
62d
Days
Class 2
Risk

K034049 is an FDA 510(k) clearance for the HERADOR EC, PF, C, H, NH, G, GG AND MP. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Heraeus Kulzer,GmbH (South Bend, US). The FDA issued a Cleared decision on March 1, 2004 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - 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 Heraeus Kulzer,GmbH devices

Submission Details

510(k) Number K034049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2003
Decision Date March 01, 2004
Days to Decision 62 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
65d faster than avg
Panel avg: 127d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJT Alloy, Gold-based Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
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.