Atlas FDA

ELL

39 FDA 510(k) clearances · Product code

78 daysmedian time to decision
216 days90th percentile
39clearances measured

FDA profile

Official device name
Teeth, Porcelain
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3920
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
1994: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Additive Manufacturing Zirconia Customized Restoration (K240586)Hangzhou Thales Medtech Co., Ltd.2024-10-03
Franz Zirconia Dental Crown (K203072)Franz Biotech, Inc.2022-01-19
NobelProcera HT ML FCZ Bridge (K162043)Nobel Biocare AB2016-11-22
NobelProcera HT ML Full Contour Zirconia Crown (K153534)Nobel Biocare AB2016-06-06
PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 (K071182)Nobel Biocare AB2007-07-11
SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302. (K060530)Lifecore Biomedical, Inc.2006-05-22
PROCERA BRIDGE ZIRCONIA (K041283)Nobel Biocare AB2004-05-28
PROCEARA COPINGS AND PONTIC (K032562)Nobel Biocare AB2004-02-06
ARGI-SATIN OR OPTI0-STAR (K965216)Argen Precious Metals, Inc.1997-02-27
MATCHMAKER/PROPAQUE PORCELAIN (K960770)Davis Schottlander & Davis, Ltd.1996-11-19
IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013 (K960480)Vident1996-03-15
VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A (K930835)Ivoclar North America, Inc.1994-07-22
CAPS (K932012)Chemichl, Inc.1993-11-03
DUCERAGOLD, DUCERATIN (K931808)Degussa AG1993-11-03
MICRODOSE SILANE (K924823)Unicep1993-03-16
MICRODOSE PORCELAIN ETCHANT (K924821)Unicep1993-03-16
IPS CERAMIC ETCHING GEL (K923926)Ivoclar North America, Inc.1992-10-27
4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL (K920460)Pulpdent Corp.1992-04-28
TYCERAMIC (K910569)Jeneric/Pentron, Inc.1991-04-15
SYSNPAR PORCELAIN (K910303)Jeneric/Pentron, Inc.1991-03-08
PROCERAM PORCELAIN (K903907)Nobelpharma USA, Inc.1990-11-09
DEN-MAT LAMI-QUICK (K895269)Den-Mat Corp.1990-02-22
CRYSTAR(TM) ANTI-GREENING LIQUID (K893481)Shofu Dental Corp.1989-07-14
TUF-COAT (K892806)G-C Intl. Corp.1989-07-14
CRYSTAR(TM) VINTAGE PORCELAIN (K884214)Shofu Dental Corp.1988-12-08
SPECTRUM (K880774)Dentsply Intl.1988-05-18
G-CERA PORCELAIN & G-CERA PORCELAIN MODIFIER (K880764)G-C Intl. Corp.1988-04-12
DEN-MAT PORETCH (PORCELAIN ETCHANT) (K875351)Den-Mat Corp.1988-03-18
DUCERAM-METAL-CERAMIC DENTAL PORCELAIN SYSTEM (K871808)Degussa Dental, Inc.1987-06-05
MODI. OF DENTAL CERAMIC FOR FABRICATION OF CROWN (K864724)Dentsply Intl.1987-02-17
ARTIFICIAL TEETH, PORCELAIN, MODIFIED (K860608)Dentsply Intl.1986-03-26
DENTAL PORCELAIN-VARIOUS (K851733)Excelco Intl., Inc.1985-10-16
CAPA PRE-FORMED PORCELAIN CROWN (K852145)Capa Industries1985-07-02
NATURA-DENT VACUUM-FIRED PORCELAIN TEETH (K841826)Parexel Intl. Corp.1984-07-12
THERMOCRAFT PORCELAIN (K840642)American Thermocraft Corp.1984-03-30
PORCELAIN ARTIFICIAL TEETH (K823744)Dentsply Intl.1982-12-28
MYERSON R&KENSON R PORCELAIN ANT&POS.- (K800829)Myerson Tooth Corp.1980-05-08
NU-GLAZE (K781935)Deringer-Ney, Inc.1978-12-20
BIOBOND MASTER STAIN AND GLAZE KIT (K771179)Dentsply Intl.1977-07-15

Track ELL automatically

Every clearance here is in the API, with alerts when new ones post.