Cleared Traditional

K952865 - REMANIUM: 200

K952865 is an FDA 510(k) clearance for REMANIUM: 200, manufactured by Dentauraum, Inc.. The device is a Class 2 Dental device with product code EJH cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K952865 · Dentauraum, Inc. · Dental device
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Jul 1995
Decision
34d
Days
Class 2
Risk

K952865 is an FDA 510(k) clearance for the REMANIUM: 200,CS, 380, AND CD. Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Dentauraum, Inc. (Newtown, US). The FDA issued a Cleared decision on July 26, 1995 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3710 - 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 Dentauraum, Inc. devices

FDA 510(k) Submission Details - K952865

510(k) Number K952865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1995
Decision Date July 26, 1995
Days to Decision 34 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
93d faster than avg
Panel avg: 127d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJH Device Classification - Class 2, Special Controls

Product Code EJH Alloy, Metal, Base
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3710
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 - EJH Alloy, Metal, Base

All 79
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K952865.
REMATITAN TITANIUM
K952866 · Dentauraum, Inc. · Jul 1995
REMANIUM:GM 700, GM 380, GM 800, GFH
K952867 · Dentauraum, Inc. · Jul 1995
REMANIUM: CS & G-SOFT
K952870 · Dentauraum, Inc. · Jul 1995
SUREFIRE PF+ (HIGH PALLADIUM DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS)
K950894 · Argen Precious Metals, Inc. · Mar 1995
VERABOND V
K945712 · Aalba Dent, Inc. · Dec 1994
VERABOND II
K945713 · Aalba Dent, Inc. · Dec 1994