Cleared Traditional

K982129 - ANTAGON PORCELAIN

K982129 is an FDA 510(k) clearance for ANTAGON PORCELAIN, manufactured by European Dental Imports, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K982129 · European Dental Imports, Inc. · Dental device
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Aug 1998
Decision
48d
Days
Class 2
Risk

K982129 is an FDA 510(k) clearance for the ANTAGON PORCELAIN. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by European Dental Imports, Inc. (Durham, US). The FDA issued a Cleared decision on August 4, 1998 after a review of 48 days - a notably fast clearance cycle.

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: 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 European Dental Imports, Inc. devices

FDA 510(k) Submission Details - K982129

510(k) Number K982129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1998
Decision Date August 04, 1998
Days to Decision 48 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 127d · This submission: 48d
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 324
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K982129.
WILLI GELLER CREATION PORCELAIN
K981490 · Jensen Industries, Inc. · Oct 1998
IPS EMPRESS 2
K982616 · Ivoclar North America, Inc. · Sep 1998
OPC LOWWEAR PORCELAIN
K982377 · Jeneric/Pentron, Inc. · Aug 1998
VITA TITANIUM PORCELAIN
K982664 · Vident · Aug 1998
PRILANE
K981524 · Gresco Products, Inc. · Jul 1998
CARRARA PORCELAIN AND CARRARA VINCENT PORCELAIN
K981000 · European Dental Imports, Inc. · May 1998