Cleared Traditional

K973539 - ROEKO CALCIUM HYDROXIDE POINTS

K973539 is an FDA 510(k) clearance for ROEKO CALCIUM HYDROXIDE POINTS, manufactured by Roeko USA, Inc.. The device is a Class 2 Dental device with product code EJK cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K973539 · Roeko USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
42d
Days
Class 2
Risk

K973539 is an FDA 510(k) clearance for the ROEKO CALCIUM HYDROXIDE POINTS. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Roeko USA, Inc. (Concord, US). The FDA issued a Cleared decision on October 30, 1997 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3250 - 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 Roeko USA, Inc. devices

FDA 510(k) Submission Details - K973539

510(k) Number K973539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1997
Decision Date October 30, 1997
Days to Decision 42 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 127d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJK Device Classification - Class 2, Special Controls

Product Code EJK Liner, Cavity, Calcium Hydroxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3250
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 - EJK Liner, Cavity, Calcium Hydroxide

All 58
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K973539.
LIFE 2
K012717 · Sybron Dental Specialties, Inc. · Oct 2001
CALCIJECT
K001050 · Centrix, Inc. · Jul 2000
SUPER SEAL
K983477 · Phoenix Dental, Inc. · Dec 1998
ULTRA-BLEND PLUS
K970113 · Ultradent Products, Inc. · Apr 1997
ULTRACAL XS
K970114 · Ultradent Products, Inc. · Mar 1997
CALCIUM HYDROXIDE MEDICAMENT
K964191 · Sybron Dental Specialties, Inc. · Jan 1997