Cleared Traditional

DENZIR (K984201) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 165
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K984201.
PFZ PORCELAIN SYSTEM
K033553 · Dentsply Intl. · Dec 2003
CERCON CERAM S PORCELAIN
K022796 · Dentsply Intl. · Sep 2002
3M TR SYSTEM
K992489 · 3M Company · Jan 2000
FINESSE ALL-CERAMIC SYSTEM
K971869 · Dentsply Intl. · Sep 1997
FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS
K961291 · Dentsply Intl. · May 1996
FINESSE LOW-FUSING PORCELAIN SYSTEM
K954761 · Dentsply Intl. · Nov 1995