Cleared Traditional

K972910 - PORS ON LITE

K972910 is an FDA 510(k) clearance for PORS ON LITE, manufactured by Degussa Corp.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K972910 · Degussa Corp. · Dental device
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Oct 1997
Decision
68d
Days
Class 2
Risk

K972910 is an FDA 510(k) clearance for the PORS ON LITE. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Degussa Corp. (South Plainfield, US). The FDA issued a Cleared decision on October 14, 1997 after a review of 68 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 Degussa Corp. devices

FDA 510(k) Submission Details - K972910

510(k) Number K972910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1997
Decision Date October 14, 1997
Days to Decision 68 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 127d · This submission: 68d
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 489
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K972910.
BW-1 (CODE NAME RD-0807)
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AALBA GOLD SOLDER
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VERA PD SOLDER
K972632 · Aalba Dent, Inc. · Aug 1997
BENCHMARK-IV
K971575 · J.F. Jelenko & Co., Inc. · Jun 1997