Cleared Traditional

K883508 - HERA H

K883508 is the FDA 510(k) clearance for HERA H by Degussa Dental, Inc.. It is a Class 2 Dental device (product code EJT) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K883508 · Degussa Dental, Inc. · Dental device
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Sep 1988
Decision
36d
Days
Class 2
Risk

K883508 is an FDA 510(k) clearance for the HERA H. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Degussa Dental, Inc. (Long Island, US). The FDA issued a Cleared decision on September 22, 1988 after a review of 36 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 Dental, Inc. devices

Submission Details

510(k) Number K883508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1988
Decision Date September 22, 1988
Days to Decision 36 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 127d · This submission: 36d
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 436
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K883508.
ARGEDENT 52SF
K891911 · Argen Precious Metals, Inc. · May 1989
ULTIMA LITE
K890568 · Deringer-Ney, Inc. · Mar 1989
NEYORO 65CF
K890569 · Deringer-Ney, Inc. · Mar 1989
JEL-5 GOLD BASED ALLOYS & PRECIOUS METAL ALLOYS
K882126 · J.F. Jelenko & Co., Inc. · Jun 1988
OLYMPIA II
K881860 · J.F. Jelenko & Co., Inc. · Jun 1988
PTM-45
K881861 · J.F. Jelenko & Co., Inc. · Jun 1988