Cleared Traditional

HARMONY LINE PF (K950517) - FDA 510(k) Clearance

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

K950517 · Ivoclar North America, Inc. · Dental device
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Mar 1995
Decision
45d
Days
Class 2
Risk

K950517 is an FDA 510(k) clearance for the HARMONY LINE PF. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on March 23, 1995 after a review of 45 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 Ivoclar North America, Inc. devices

Submission Details

510(k) Number K950517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1995
Decision Date March 23, 1995
Days to Decision 45 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
82d faster than avg
Panel avg: 127d · This submission: 45d
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.

Regulatory Peers - EJT Alloy, Gold-based Noble Metal

All 208
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K950517.
AUROLITE 45
K954404 · Argen Precious Metals, Inc. · Oct 1995
AUROLITE 80
K952403 · Argen Precious Metals, Inc. · Jun 1995
AURIUM 68M
K952402 · Argen Precious Metals, Inc. · Jun 1995
AUROLITE 55
K950858 · Argen Precious Metals, Inc. · Mar 1995
ARGELITE 61 (PALLADIUM - SILVER DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS)
K950772 · Argen Precious Metals, Inc. · Mar 1995
SOLDER AUROLITE CB
K943755 · Argen Precious Metals, Inc. · Sep 1994