Cleared Traditional

K883512 - HERAEUS WHITE

K883512 is an FDA 510(k) clearance for HERAEUS WHITE, manufactured by Degussa Dental, Inc.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K883512 · Degussa Dental, Inc. · Dental device
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Sep 1988
Decision
20d
Days
Class 2
Risk

K883512 is an FDA 510(k) clearance for the HERAEUS WHITE. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Degussa Dental, Inc. (Long Island, US). The FDA issued a Cleared decision on September 6, 1988 after a review of 20 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

FDA 510(k) Submission Details - K883512

510(k) Number K883512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1988
Decision Date September 06, 1988
Days to Decision 20 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
107d faster than avg
Panel avg: 127d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJS Device Classification - Class 2, Special Controls

Product Code EJS Alloy, Other 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 - EJS Alloy, Other Noble Metal

All 171
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K883512.
HERAEUS DG 63
K883509 · Degussa Dental, Inc. · Sep 1988
HERAEUS C SPECIAL
K883507 · Degussa Dental, Inc. · Sep 1988
DEGUPAL 4
K883510 · Degussa Dental, Inc. · Sep 1988
LUNAR CASTING ALLOY FOR PORCELAIN-FUSED-TO-METAL
K874821 · Deringer-Ney, Inc. · Feb 1988
GDC 1830 CASTING ALLOY
K871288 · Deringer-Ney, Inc. · Apr 1987
DEGUPAL
K864162 · Degussa Dental, Inc. · Nov 1986