ELL — Teeth, Porcelain Class II
FDA product code ELL covers "Teeth, Porcelain", a Class II medical device regulated under 21 CFR 872.3920. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ELL
- Device Class
- Class II
- Regulation Number
- 872.3920
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240586 | hangzhou thales medtech co | Additive Manufacturing Zirconia Customized Restoration | October 3, 2024 |
| K203072 | franz biotech | Franz Zirconia Dental Crown | January 19, 2022 |
| K162043 | nobel biocare | NobelProcera HT ML FCZ Bridge | November 22, 2016 |
| K153534 | nobel biocare | NobelProcera HT ML Full Contour Zirconia Crown | June 6, 2016 |
| K071182 | nobel biocare | PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 | July 11, 2007 |
| K060530 | lifecore biomedical | SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING F | May 22, 2006 |
| K041283 | nobel biocare | PROCERA BRIDGE ZIRCONIA | May 28, 2004 |
| K032562 | nobel biocare | PROCEARA COPINGS AND PONTIC | February 6, 2004 |
| K965216 | argen precious metals | ARGI-SATIN OR OPTI0-STAR | February 27, 1997 |
| K960770 | davis schottlander and davis | MATCHMAKER/PROPAQUE PORCELAIN | November 19, 1996 |
| K960480 | vident | IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013 | March 15, 1996 |
| K930835 | ivoclar north america | VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A | July 22, 1994 |
| K932012 | chemichl | CAPS | November 3, 1993 |
| K931808 | degussa | DUCERAGOLD, DUCERATIN | November 3, 1993 |
| K924823 | unicep | MICRODOSE SILANE | March 16, 1993 |
| K924821 | unicep | MICRODOSE PORCELAIN ETCHANT | March 16, 1993 |
| K923926 | ivoclar north america | IPS CERAMIC ETCHING GEL | October 27, 1992 |
| K920460 | pulpdent | 4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL | April 28, 1992 |
| K910569 | jeneric/pentron | TYCERAMIC | April 15, 1991 |
| K910303 | jeneric/pentron | SYSNPAR PORCELAIN | March 8, 1991 |