Cleared Traditional

K012438 - MODIFICATION TO PANAVIA 21

K012438 is an FDA 510(k) clearance for MODIFICATION TO PANAVIA 21, manufactured by Kuraray Medical, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K012438 · Kuraray Medical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
36d
Days
Class 2
Risk

K012438 is an FDA 510(k) clearance for the MODIFICATION TO PANAVIA 21. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Kuraray Medical, Inc. (New York, US). The FDA issued a Cleared decision on September 5, 2001 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Kuraray Medical, Inc. devices

FDA 510(k) Submission Details - K012438

510(k) Number K012438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2001
Decision Date September 05, 2001
Days to Decision 36 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
91d faster than avg
Panel avg: 127d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 421
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K012438.
NEXUS 2 MODIFIED
K013008 · Sybron Dental Specialties, Inc. · Oct 2001
CLEARFIL DC CEMENT
K012735 · Kuraray Medical, Inc. · Sep 2001
PANAVIA F
K012441 · Kuraray Medical, Inc. · Sep 2001
TOKUYAMA M-BOND
K011854 · Tokuyama America, Inc. · Sep 2001
PERMACEM / PERMACEM DUAL
K012316 · Dmg USA, Inc. · Aug 2001
PREVISION CHEM
K010541 · Heraeus Kulzer, Inc. · Jul 2001