Cleared Traditional

K981000 - CARRARA PORCELAIN AND CARRARA VINCENT PORCELAIN

K981000 is an FDA 510(k) clearance for CARRARA PORCELAIN AND CARRARA VINCENT P..., 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 58-day FDA review.

K981000 · European Dental Imports, Inc. · Dental device
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May 1998
Decision
58d
Days
Class 2
Risk

K981000 is an FDA 510(k) clearance for the CARRARA PORCELAIN AND CARRARA VINCENT 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 May 15, 1998 after a review of 58 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 - K981000

510(k) Number K981000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1998
Decision Date May 15, 1998
Days to Decision 58 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
69d faster than avg
Panel avg: 127d · This submission: 58d
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 K981000.
ANTAGON PORCELAIN
K982129 · European Dental Imports, Inc. · Aug 1998
VITA TITANIUM PORCELAIN
K982664 · Vident · Aug 1998
PRILANE
K981524 · Gresco Products, Inc. · Jul 1998
PROCAD
K980986 · Ivoclar USA, Inc. · May 1998
SONICSYS INLAY
K972648 · Ivoclar North America, Inc. · Oct 1997
VINTAGE HALO
K973247 · Shofu Dental Corp. · Oct 1997