Cleared Traditional

K990670 - HELIOFORM GOLD-BASED ALLOY

K990670 is an FDA 510(k) clearance for HELIOFORM GOLD-BASED ALLOY, manufactured by C. Hafner GmbH & Co.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K990670 · C. Hafner GmbH & Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
31d
Days
Class 2
Risk

K990670 is an FDA 510(k) clearance for the HELIOFORM GOLD-BASED ALLOY. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by C. Hafner GmbH & Co. (Chicago, US). The FDA issued a Cleared decision on April 2, 1999 after a review of 31 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 C. Hafner GmbH & Co. devices

FDA 510(k) Submission Details - K990670

510(k) Number K990670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1999
Decision Date April 02, 1999
Days to Decision 31 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 127d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJT Device Classification - Class 2, Special Controls

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 549
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K990670.
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BIO-97
K991901 · Jeneric/Pentron, Inc. · Sep 1999
MAINBOND A
K984140 · J.F. Jelenko & Co., Inc. · Jan 1999
AUROLLOYD KF
K983080 · Bego U.S.A. · Oct 1998
BEGOCER G
K983082 · Bego U.S.A. · Oct 1998