Cleared Traditional

K884214 - CRYSTAR(TM) VINTAGE PORCELAIN

K884214 is the FDA 510(k) clearance for CRYSTAR(TM) VINTAGE PORCELAIN by Shofu Dental Corp.. It is a Class 2 Dental device (product code ELL) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K884214 · Shofu Dental Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1988
Decision
63d
Days
Class 2
Risk

K884214 is an FDA 510(k) clearance for the CRYSTAR(TM) VINTAGE PORCELAIN. Classified as Teeth, Porcelain (product code ELL), Class II - Special Controls.

Submitted by Shofu Dental Corp. (Menlo Park, US). The FDA issued a Cleared decision on December 8, 1988 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3920 - 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 Shofu Dental Corp. devices

Submission Details

510(k) Number K884214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1988
Decision Date December 08, 1988
Days to Decision 63 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 127d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELL Teeth, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3920
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 - ELL Teeth, Porcelain

All 20
Devices cleared under the same product code (ELL) and FDA review panel - the closest regulatory comparables to K884214.
SYSNPAR PORCELAIN
K910303 · Jeneric/Pentron, Inc. · Mar 1991
PROCERAM PORCELAIN
K903907 · Nobelpharma USA, Inc. · Nov 1990
CRYSTAR(TM) ANTI-GREENING LIQUID
K893481 · Shofu Dental Corp. · Jul 1989
SPECTRUM
K880774 · Dentsply Intl. · May 1988
MODI. OF DENTAL CERAMIC FOR FABRICATION OF CROWN
K864724 · Dentsply Intl. · Feb 1987
ARTIFICIAL TEETH, PORCELAIN, MODIFIED
K860608 · Dentsply Intl. · Mar 1986