ELL · Class II · 21 CFR 872.3920

FDA Product Code ELL: Teeth, Porcelain

Leading manufacturers include Nobel Biocare AB, Dentsply Intl. and Den-Mat Corp..

39
Total
39
Cleared
115d
Avg days
1977
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 216d recently vs 112d historically

FDA 510(k) Cleared Teeth, Porcelain Devices (Product Code ELL)

39 devices
1–24 of 39
Cleared Oct 03, 2024
Additive Manufacturing Zirconia Customized Restoration
K240586
Hangzhou Thales Medtech Co., Ltd.
Dental · 216d
Cleared Jan 19, 2022
Franz Zirconia Dental Crown
K203072
Franz Biotech, Inc.
Dental · 467d
Cleared Nov 22, 2016
NobelProcera HT ML FCZ Bridge
K162043
Nobel Biocare AB
Dental · 120d
Cleared Jun 06, 2016
NobelProcera HT ML Full Contour Zirconia Crown
K153534
Nobel Biocare AB
Dental · 180d
Cleared Jul 11, 2007
PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013
K071182
Nobel Biocare AB
Dental · 72d
Cleared May 22, 2006
SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.
K060530
Lifecore Biomedical, Inc.
Dental · 83d
Cleared May 28, 2004
PROCERA BRIDGE ZIRCONIA
K041283
Nobel Biocare AB
Dental · 15d
Cleared Feb 06, 2004
PROCEARA COPINGS AND PONTIC
K032562
Nobel Biocare AB
Dental · 170d
Cleared Feb 27, 1997
ARGI-SATIN OR OPTI0-STAR
K965216
Argen Precious Metals, Inc.
Dental · 59d
Cleared Mar 15, 1996
IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013
K960480
Vident
Dental · 42d
Cleared Jul 22, 1994
VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A
K930835
Ivoclar North America, Inc.
Dental · 520d
Cleared Nov 03, 1993
DUCERAGOLD, DUCERATIN
K931808
Degussa AG
Dental · 205d
Cleared Oct 27, 1992
IPS CERAMIC ETCHING GEL
K923926
Ivoclar North America, Inc.
Dental · 83d
Cleared Apr 28, 1992
4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL
K920460
Pulpdent Corp.
Dental · 92d
Cleared Apr 15, 1991
TYCERAMIC
K910569
Jeneric/Pentron, Inc.
Dental · 63d
Cleared Mar 08, 1991
SYSNPAR PORCELAIN
K910303
Jeneric/Pentron, Inc.
Dental · 43d
Cleared Nov 09, 1990
PROCERAM PORCELAIN
K903907
Nobelpharma USA, Inc.
Dental · 78d
Cleared Feb 22, 1990
DEN-MAT LAMI-QUICK
K895269
Den-Mat Corp.
Dental · 183d
Cleared Jul 14, 1989
CRYSTAR(TM) ANTI-GREENING LIQUID
K893481
Shofu Dental Corp.
Dental · 71d
Cleared Dec 08, 1988
CRYSTAR(TM) VINTAGE PORCELAIN
K884214
Shofu Dental Corp.
Dental · 63d
Cleared May 18, 1988
SPECTRUM
K880774
Dentsply Intl.
Dental · 82d
Cleared Mar 18, 1988
DEN-MAT PORETCH (PORCELAIN ETCHANT)
K875351
Den-Mat Corp.
Dental · 78d
Cleared Feb 17, 1987
MODI. OF DENTAL CERAMIC FOR FABRICATION OF CROWN
K864724
Dentsply Intl.
Dental · 77d
Cleared Mar 26, 1986
ARTIFICIAL TEETH, PORCELAIN, MODIFIED
K860608
Dentsply Intl.
Dental · 35d

About Product Code ELL - Regulatory Context

510(k) Submission Activity

39 total 510(k) submissions under product code ELL since 1977, with 39 receiving FDA clearance (average review time: 115 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - ELL Product Code

Recent submissions under ELL have taken an average of 216 days to reach a decision - up from 112 days historically. Manufacturers should account for longer review timelines in current project planning.

ELL devices are reviewed by the Dental panel. Browse all Dental devices →