Product code ELL
- Device name
- Teeth, Porcelain
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.3920
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240586 | Additive Manufacturing Zirconia Customized Restoration | Hangzhou Thales Medtech Co., Ltd. | 2024-10-03 |
| K203072 | Franz Zirconia Dental Crown | Franz Biotech, Inc. | 2022-01-19 |
| K162043 | NobelProcera HT ML FCZ Bridge | Nobel Biocare AB | 2016-11-22 |
| K153534 | NobelProcera HT ML Full Contour Zirconia Crown | Nobel Biocare AB | 2016-06-06 |
| K071182 | PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 | Nobel Biocare AB | 2007-07-11 |
| K060530 | SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302. | Lifecore Biomedical, Inc. | 2006-05-22 |
| K041283 | PROCERA BRIDGE ZIRCONIA | Nobel Biocare AB | 2004-05-28 |
| K032562 | PROCEARA COPINGS AND PONTIC | Nobel Biocare AB | 2004-02-06 |
| K965216 | ARGI-SATIN OR OPTI0-STAR | Argen Precious Metals, Inc. | 1997-02-27 |
| K960770 | MATCHMAKER/PROPAQUE PORCELAIN | Davis Schottlander & Davis, Ltd. | 1996-11-19 |
| K960480 | IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013 | Vident | 1996-03-15 |
| K930835 | VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A | Ivoclar North America, Inc. | 1994-07-22 |
| K932012 | CAPS | Chemichl, Inc. | 1993-11-03 |
| K931808 | DUCERAGOLD, DUCERATIN | Degussa AG | 1993-11-03 |
| K924823 | MICRODOSE SILANE | Unicep | 1993-03-16 |
| K924821 | MICRODOSE PORCELAIN ETCHANT | Unicep | 1993-03-16 |
| K923926 | IPS CERAMIC ETCHING GEL | Ivoclar North America, Inc. | 1992-10-27 |
| K920460 | 4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL | Pulpdent Corp. | 1992-04-28 |
| K910569 | TYCERAMIC | Jeneric/Pentron, Inc. | 1991-04-15 |
| K910303 | SYSNPAR PORCELAIN | Jeneric/Pentron, Inc. | 1991-03-08 |
| K903907 | PROCERAM PORCELAIN | Nobelpharma USA, Inc. | 1990-11-09 |
| K895269 | DEN-MAT LAMI-QUICK | Den-Mat Corp. | 1990-02-22 |
| K892806 | TUF-COAT | G-C Intl. Corp. | 1989-07-14 |
| K893481 | CRYSTAR(TM) ANTI-GREENING LIQUID | Shofu Dental Corp. | 1989-07-14 |
| K884214 | CRYSTAR(TM) VINTAGE PORCELAIN | Shofu Dental Corp. | 1988-12-08 |
| K880774 | SPECTRUM | Dentsply Intl. | 1988-05-18 |
| K880764 | G-CERA PORCELAIN & G-CERA PORCELAIN MODIFIER | G-C Intl. Corp. | 1988-04-12 |
| K875351 | DEN-MAT PORETCH (PORCELAIN ETCHANT) | Den-Mat Corp. | 1988-03-18 |
| K871808 | DUCERAM-METAL-CERAMIC DENTAL PORCELAIN SYSTEM | Degussa Dental, Inc. | 1987-06-05 |
| K864724 | MODI. OF DENTAL CERAMIC FOR FABRICATION OF CROWN | Dentsply Intl. | 1987-02-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00817340021783 | Jensen ECO Zirconia | JENSEN INDUSTRIES INC. | 2016-09-23 |
| 00817340021769 | Jensen ECO Zirconia | JENSEN INDUSTRIES INC. | 2016-09-23 |
| D724Q2500561 | Vivid ZirDisc Amman Girrbach System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-31 |
| D724Q2500541 | Vivid ZirDisc Amman Girrbach System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-31 |
| D724Q2500521 | Vivid ZirDisc Amman Girrbach System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-31 |
| D724Q2500501 | Vivid ZirDisc Amman Girrbach System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-31 |
| D724Q2500481 | Vivid ZirDisc Amman Girrbach System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-31 |
| D724Q2500461 | Vivid ZirDisc Amman Girrbach System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-31 |
| D724Q2500441 | Vivid ZirDisc Amman Girrbach System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-31 |
| D724Q2500421 | Vivid ZirDisc Amman Girrbach System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-31 |
| D724Q2500401 | Vivid ZirDisc Amman Girrbach System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-31 |
| D724Q2500381 | Vivid ZirDisc Amman Girrbach System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-31 |
| D724Q2500361 | Vivid ZirDisc Wieland System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-31 |
| D724Q2500341 | Vivid ZirDisc Wieland System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-31 |
| D724Q2500321 | Vivid ZirDisc Wieland System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-31 |
| D724Q2500281 | Vivid ZirDisc Wieland System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-29 |
| D724Q2500301 | Vivid ZirDisc Wieland System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-29 |
| D724Q2500261 | Vivid ZirDisc Wieland System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-29 |
| D724Q2500241 | Vivid ZirDisc Wieland System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-29 |
| D724Q2500221 | Vivid ZirDisc Wieland System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-29 |
| D724Q2500201 | Vivid ZirDisc Wieland System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-29 |
| D724Q2500181 | Vivid ZirDisc Wieland System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-29 |
| D724Q2500161 | Vivid ZirDisc Wieland System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-29 |
| D724Q2500141 | Vivid ZirDisc Wieland System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-29 |
| D724Q2500121 | Vivid ZirDisc Wieland System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-29 |
| D724Q2500101 | Vivid ZirDisc Wieland System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-29 |
| D724Q2500081 | Vivid ZirDisc Wieland System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-29 |
| D724Q2500061 | Vivid ZirDisc Wieland System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-29 |
| D724Q2500041 | Vivid ZirDisc Wieland System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-29 |
| D724Q2500021 | Vivid ZirDisc Wieland System | PEARSON DENTAL SUPPLIES, INC. | 2016-08-29 |