Cleared Traditional

K983361 - PANAVIA F

K983361 is an FDA 510(k) clearance for PANAVIA F, manufactured by Kuraray America, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K983361 · Kuraray America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
50d
Days
Class 2
Risk

K983361 is an FDA 510(k) clearance for the PANAVIA F. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Kuraray America, Inc. (New York, US). The FDA issued a Cleared decision on November 13, 1998 after a review of 50 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 America, Inc. devices

FDA 510(k) Submission Details - K983361

510(k) Number K983361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1998
Decision Date November 13, 1998
Days to Decision 50 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 127d · This submission: 50d
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 374
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K983361.
PROCEM
K984248 · Espe Dental AG · Jan 1999
STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281
K984340 · Sterngold/Implamed · Jan 1999
ALUMINA-ZINC OXIDE POWDERS F AND R
K983752 · Harry J. Bosworth Co. · Dec 1998
QUICKSET LIQUID AND POWDER
K982773 · Specialites Septodont · Nov 1998
ZINFOS ZINC PHOSPHATE CEMENT
K982913 · Scientific Pharmaceuticals, Inc. · Oct 1998
STERNOMEGA COMPOMER CEMENT
K982895 · Sterngold/Implamed · Oct 1998