Cleared Traditional

K896663 - ENDO-PREP

K896663 is an FDA 510(k) clearance for ENDO-PREP, manufactured by Pulpdent Corp.. The device is a Class 1 Dental device with product code EKM cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K896663 · Pulpdent Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1990
Decision
82d
Days
Class 1
Risk

K896663 is an FDA 510(k) clearance for the ENDO-PREP. Classified as Gutta-percha (product code EKM), Class I - General Controls.

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on February 14, 1990 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3850 - 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.

FDA 510(k) Submission Details - K896663

510(k) Number K896663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1989
Decision Date February 14, 1990
Days to Decision 82 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
46d faster than avg
Panel avg: 128d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

EKM Device Classification - Class 1, General Controls

Product Code EKM Gutta-percha
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3850
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 - EKM Gutta-percha

All 22
Devices cleared under the same product code (EKM) and FDA review panel - the closest regulatory comparables to K896663.
TOUCH 'N HEAT MODEL 5002, MODIFICATION
K915243 · Analytic Technology · Jan 1992
THERMAPREP
K910224 · Tulsa Dental Products, Ltd. · Mar 1991
THERMAFIL ENDODONTIC OBTURATOR
K900986 · Tulsa Dental Products, Ltd. · Nov 1990
THERMAFIL ENDODONTIC OBTURATOR
K881139 · Tulsa Dental Products, Ltd. · Apr 1988
GUTTA PERCHA
K863411 · Endodent, Inc. · Oct 1986
GUTTA PERCHA POINTS
K863638 · Endodent, Inc. · Oct 1986
K896663 · ENDO-PREP
Download PDF Pulpdent Corp.