FDA Product Code
FDA Product Code ELL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3920
510(k) Clearances — 39 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240586 | Additive Manufacturing Zirconia Customized Restoration | Hangzhou Thales Medtech Co., Ltd. | 2024-10-03 | Traditional | PDF ↗ |
| K203072 | Franz Zirconia Dental Crown | Franz Biotech, Inc. | 2022-01-19 | Traditional | PDF ↗ |
| K162043 | NobelProcera HT ML FCZ Bridge | Nobel Biocare AB | 2016-11-22 | Traditional | PDF ↗ |
| K153534 | NobelProcera HT ML Full Contour Zirconia Crown | Nobel Biocare AB | 2016-06-06 | Traditional | PDF ↗ |
| K071182 | PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 | Nobel Biocare AB | 2007-07-11 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K041283 | PROCERA BRIDGE ZIRCONIA | Nobel Biocare AB | 2004-05-28 | Traditional | PDF ↗ |
| K032562 | PROCEARA COPINGS AND PONTIC | Nobel Biocare AB | 2004-02-06 | Traditional | PDF ↗ |
| K965216 | ARGI-SATIN OR OPTI0-STAR | Argen Precious Metals, Inc. | 1997-02-27 | Traditional | PDF ↗ |
| K960770 | MATCHMAKER/PROPAQUE PORCELAIN | Davis Schottlander & Davis, Ltd. | 1996-11-19 | Traditional | PDF ↗ |
| K960480 | IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013 | Vident | 1996-03-15 | Traditional | PDF ↗ |
| K930835 | VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A | Ivoclar North America, Inc. | 1994-07-22 | Traditional | PDF ↗ |
| K932012 | CAPS | Chemichl, Inc. | 1993-11-03 | Traditional | PDF ↗ |
| K931808 | DUCERAGOLD, DUCERATIN | Degussa AG | 1993-11-03 | Traditional | PDF ↗ |
| K924823 | MICRODOSE SILANE | Unicep | 1993-03-16 | Traditional | PDF ↗ |
| K924821 | MICRODOSE PORCELAIN ETCHANT | Unicep | 1993-03-16 | Traditional | PDF ↗ |
| K923926 | IPS CERAMIC ETCHING GEL | Ivoclar North America, Inc. | 1992-10-27 | Traditional | PDF ↗ |
| K920460 | 4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL | Pulpdent Corp. | 1992-04-28 | Traditional | PDF ↗ |
| K910569 | TYCERAMIC | Jeneric/Pentron, Inc. | 1991-04-15 | Traditional | PDF ↗ |
| K910303 | SYSNPAR PORCELAIN | Jeneric/Pentron, Inc. | 1991-03-08 | Traditional | PDF ↗ |
| K903907 | PROCERAM PORCELAIN | Nobelpharma USA, Inc. | 1990-11-09 | Traditional | PDF ↗ |
| K895269 | DEN-MAT LAMI-QUICK | Den-Mat Corp. | 1990-02-22 | Traditional | PDF ↗ |
| K893481 | CRYSTAR(TM) ANTI-GREENING LIQUID | Shofu Dental Corp. | 1989-07-14 | Traditional | PDF ↗ |
| K892806 | TUF-COAT | G-C Intl. Corp. | 1989-07-14 | Traditional | PDF ↗ |
| K884214 | CRYSTAR(TM) VINTAGE PORCELAIN | Shofu Dental Corp. | 1988-12-08 | Traditional | PDF ↗ |
| K880774 | SPECTRUM | Dentsply Intl. | 1988-05-18 | Traditional | PDF ↗ |
| K880764 | G-CERA PORCELAIN & G-CERA PORCELAIN MODIFIER | G-C Intl. Corp. | 1988-04-12 | Traditional | PDF ↗ |
| K875351 | DEN-MAT PORETCH (PORCELAIN ETCHANT) | Den-Mat Corp. | 1988-03-18 | Traditional | PDF ↗ |
| K871808 | DUCERAM-METAL-CERAMIC DENTAL PORCELAIN SYSTEM | Degussa Dental, Inc. | 1987-06-05 | Traditional | PDF ↗ |
| K864724 | MODI. OF DENTAL CERAMIC FOR FABRICATION OF CROWN | Dentsply Intl. | 1987-02-17 | Traditional | PDF ↗ |
| K860608 | ARTIFICIAL TEETH, PORCELAIN, MODIFIED | Dentsply Intl. | 1986-03-26 | Traditional | PDF ↗ |
| K851733 | DENTAL PORCELAIN-VARIOUS | Excelco Intl., Inc. | 1985-10-16 | Traditional | PDF ↗ |
| K852145 | CAPA PRE-FORMED PORCELAIN CROWN | Capa Industries | 1985-07-02 | Traditional | PDF ↗ |
| K841826 | NATURA-DENT VACUUM-FIRED PORCELAIN TEETH | Parexel Intl. Corp. | 1984-07-12 | Traditional | PDF ↗ |
| K840642 | THERMOCRAFT PORCELAIN | American Thermocraft Corp. | 1984-03-30 | Traditional | PDF ↗ |
| K823744 | PORCELAIN ARTIFICIAL TEETH | Dentsply Intl. | 1982-12-28 | Traditional | PDF ↗ |
| K800829 | MYERSON R&KENSON R PORCELAIN ANT&POS.- | Myerson Tooth Corp. | 1980-05-08 | Traditional | PDF ↗ |
| K781935 | NU-GLAZE | Deringer-Ney, Inc. | 1978-12-20 | Traditional | PDF ↗ |
| K771179 | BIOBOND MASTER STAIN AND GLAZE KIT | Dentsply Intl. | 1977-07-15 | Traditional | PDF ↗ |
Product code ELL · Class II · Dental. Data: openFDA.