Cleared Traditional

K914368 - PART 872 DEGUFILL H & DEGUFILL M DA

K914368 is the FDA 510(k) clearance for PART 872 DEGUFILL H & DEGUFILL M DA by Degussa AG. It is a Class 1 Dental device (product code EKJ) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K914368 · Degussa AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1991
Decision
43d
Days
Class 1
Risk

K914368 is an FDA 510(k) clearance for the PART 872 DEGUFILL H & DEGUFILL M DA. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Degussa AG (South Plainfield, US). The FDA issued a Cleared decision on November 13, 1991 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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 AG devices

Submission Details

510(k) Number K914368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1991
Decision Date November 13, 1991
Days to Decision 43 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
84d faster than avg
Panel avg: 127d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKJ Burnisher, Operative
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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.

Regulatory Peers - EKJ Burnisher, Operative

All 15
Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K914368.
PRESTERILIZED ENDODONTIC FILES
K943584 · Dentsply Intl. · Sep 1994
AMD DENTIST AND HYGIENIST KITS
K925115 · Advance Medical Designs, Inc. · Jul 1994
APPLICATOR NOZZLE
K926368 · Centrix, Inc. · Sep 1993
HARDCOATED PLASTIC FILLING INSTRUMENT
K912149 · Premier Dental Products Co. · Jun 1991
PULPDENT PIC N STIC
K911281 · Pulpdent Corp. · May 1991
MIRROR SHIELD
K901053 · Pulpdent Corp. · May 1990