Cleared Traditional

K952868 - DENTAURUM JACKET CROWN & ROOT POSTS

K952868 is an FDA 510(k) clearance for DENTAURUM JACKET CROWN & ROOT POSTS, manufactured by Dentauraum, Inc.. The device is a Class 1 Dental device with product code EBL cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K952868 · Dentauraum, Inc. · Dental device
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Jul 1995
Decision
27d
Days
Class 1
Risk

K952868 is an FDA 510(k) clearance for the DENTAURUM JACKET CROWN & ROOT POSTS. Classified as Pin, Retentive And Splinting, And Accessory Instruments (product code EBL), Class I - General Controls.

Submitted by Dentauraum, Inc. (Newtown, US). The FDA issued a Cleared decision on July 19, 1995 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3740 - 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 - K952868

510(k) Number K952868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1995
Decision Date July 19, 1995
Days to Decision 27 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
100d faster than avg
Panel avg: 127d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

EBL Device Classification - Class 1, General Controls

Product Code EBL Pin, Retentive And Splinting, And Accessory Instruments
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3740
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.