Cleared Traditional

K984201 - DENZIR

K984201 is an FDA 510(k) clearance for DENZIR, manufactured by Dentronic AB. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K984201 · Dentronic AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
309d
Days
Class 2
Risk

K984201 is an FDA 510(k) clearance for the DENZIR. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Dentronic AB (931 27 Skellettea, SE). The FDA issued a Cleared decision on September 29, 1999 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dentronic AB devices

FDA 510(k) Submission Details - K984201

510(k) Number K984201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1998
Decision Date September 29, 1999
Days to Decision 309 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
182d slower than avg
Panel avg: 127d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 350
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K984201.
3M TR SYSTEM
K992489 · 3M Company · Jan 2000
CERGOGOLD
K993897 · Degussa - Ney Dental, Inc. · Jan 2000
OPC LOW WEAR OPAQUE PORCELAIN
K993249 · Jeneric/Pentron, Inc. · Nov 1999
CERANA
K992161 · Nordiska Dental AB · Sep 1999
GRAND CERAM
K992023 · Noritake Co., Inc. · Sep 1999
SUPER PORCELAIN TI-22
K992024 · Noritake Co., Inc. · Aug 1999