Cleared Traditional

K813417 - INZOMA P

K813417 is an FDA 510(k) clearance for INZOMA P, manufactured by J. Aderer, Inc.. 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.

K813417 · J. Aderer, Inc. · Dental device
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Jan 1982
Decision
31d
Days
Class 2
Risk

K813417 is an FDA 510(k) clearance for the INZOMA P. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by J. Aderer, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 7, 1982 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 J. Aderer, Inc. devices

FDA 510(k) Submission Details - K813417

510(k) Number K813417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1981
Decision Date January 07, 1982
Days to Decision 31 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
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 489
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K813417.
E.G. BRIDGE GOLD
K821613 · J. Aderer, Inc. · Jun 1982
SPECIAL WHITE
K820318 · J. Aderer, Inc. · Mar 1982
GDC-1130
K820277 · Deringer-Ney, Inc. · Feb 1982
GDC-1054
K810789 · Deringer-Ney, Inc. · Apr 1981
GDC 802-DEVELOPMENT NAME
K792210 · Deringer-Ney, Inc. · Nov 1979
HOWMEDICA A-30 DENTAL ALLOY
K791304 · Howmedica Corp. · Oct 1979