Teeth, Porcelain
Regulation 872.3920
0510(k)s in 12 months (39 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in ELL
| Company | 510(k)s | Recalls |
|---|---|---|
| Dentsply Intl. | 5 | 0 |
| Nobel Biocare AB | 5 | 0 |
| Den-Mat Corp. | 2 | 0 |
| G-C Intl. Corp. | 2 | 0 |
| Ivoclar North America, Inc. | 2 | 0 |
| Jeneric/Pentron, Inc. | 2 | 0 |
| Shofu Dental Corp. | 2 | 0 |
| Unicep | 2 | 0 |
| American Thermocraft Corp. | 1 | 0 |
| Argen Precious Metals, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 3, 2024 | K240586 | Additive Manufacturing Zirconia Customized Restoration Hangzhou Thales Medtech Co., Ltd., CN | ELL |
| Jan 19, 2022 | K203072 | Franz Zirconia Dental Crown Franz Biotech, Inc., TW | ELL |
| Nov 22, 2016 | K162043 | NobelProcera HT ML FCZ Bridge Nobel Biocare AB, SE | ELL |
| Jun 6, 2016 | K153534 | NobelProcera HT ML Full Contour Zirconia Crown Nobel Biocare AB, SE | ELL |
| Jul 11, 2007 | K071182 | PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 Nobel Biocare AB | ELL |
| May 22, 2006 | K060530 | SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302. Lifecore Biomedical, Inc. | ELL |
| May 28, 2004 | K041283 | PROCERA BRIDGE ZIRCONIA Nobel Biocare AB | ELL |
| Feb 6, 2004 | K032562 | PROCEARA COPINGS AND PONTIC Nobel Biocare AB | ELL |
| Feb 27, 1997 | K965216 | ARGI-SATIN OR OPTI0-STAR Argen Precious Metals, Inc. | ELL |
| Nov 19, 1996 | K960770 | MATCHMAKER/PROPAQUE PORCELAIN Davis Schottlander & Davis, Ltd., GB | ELL |
| Mar 15, 1996 | K960480 | IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013 Vident | ELL |
| Jul 22, 1994 | K930835 | VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A Ivoclar North America, Inc. | ELL |
| Nov 3, 1993 | K932012 | CAPS Chemichl, Inc. | ELL |
| Nov 3, 1993 | K931808 | DUCERAGOLD, DUCERATIN Degussa AG | ELL |
| Mar 16, 1993 | K924823 | MICRODOSE SILANE Unicep | ELL |
| Mar 16, 1993 | K924821 | MICRODOSE PORCELAIN ETCHANT Unicep | ELL |
| Oct 27, 1992 | K923926 | IPS CERAMIC ETCHING GEL Ivoclar North America, Inc. | ELL |
| Apr 28, 1992 | K920460 | 4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL Pulpdent Corp. | ELL |
| Apr 15, 1991 | K910569 | TYCERAMIC Jeneric/Pentron, Inc. | ELL |
| Mar 8, 1991 | K910303 | SYSNPAR PORCELAIN Jeneric/Pentron, Inc. | ELL |
| Nov 9, 1990 | K903907 | PROCERAM PORCELAIN Nobelpharma USA, Inc. | ELL |
| Feb 22, 1990 | K895269 | DEN-MAT LAMI-QUICK Den-Mat Corp. | ELL |
| Jul 14, 1989 | K893481 | CRYSTAR(TM) ANTI-GREENING LIQUID Shofu Dental Corp. | ELL |
| Jul 14, 1989 | K892806 | TUF-COAT G-C Intl. Corp. | ELL |
| Dec 8, 1988 | K884214 | CRYSTAR(TM) VINTAGE PORCELAIN Shofu Dental Corp. | ELL |
| May 18, 1988 | K880774 | SPECTRUM Dentsply Intl. | ELL |
| Apr 12, 1988 | K880764 | G-CERA PORCELAIN & G-CERA PORCELAIN MODIFIER G-C Intl. Corp. | ELL |
| Mar 18, 1988 | K875351 | DEN-MAT PORETCH (PORCELAIN ETCHANT) Den-Mat Corp. | ELL |
| Jun 5, 1987 | K871808 | DUCERAM-METAL-CERAMIC DENTAL PORCELAIN SYSTEM Degussa Dental, Inc. | ELL |
| Feb 17, 1987 | K864724 | MODI. OF DENTAL CERAMIC FOR FABRICATION OF CROWN Dentsply Intl. | ELL |
| Mar 26, 1986 | K860608 | ARTIFICIAL TEETH, PORCELAIN, MODIFIED Dentsply Intl. | ELL |
| Oct 16, 1985 | K851733 | DENTAL PORCELAIN-VARIOUS Excelco Intl., Inc. | ELL |
| Jul 2, 1985 | K852145 | CAPA PRE-FORMED PORCELAIN CROWN Capa Industries | ELL |
| Jul 12, 1984 | K841826 | NATURA-DENT VACUUM-FIRED PORCELAIN TEETH Parexel Intl. Corp. | ELL |
| Mar 30, 1984 | K840642 | THERMOCRAFT PORCELAIN American Thermocraft Corp. | ELL |
| Dec 28, 1982 | K823744 | PORCELAIN ARTIFICIAL TEETH Dentsply Intl. | ELL |
| May 8, 1980 | K800829 | MYERSON R&KENSON R PORCELAIN ANT&POS.- Myerson Tooth Corp. | ELL |
| Dec 20, 1978 | K781935 | NU-GLAZE Deringer-Ney, Inc. | ELL |
| Jul 15, 1977 | K771179 | BIOBOND MASTER STAIN AND GLAZE KIT Dentsply Intl. | ELL |
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