ELL · Teeth, Porcelain
Dental · 21 CFR 872.3920 · Class 2
Overview
| Product Code | ELL |
|---|---|
| Device Name | Teeth, Porcelain |
| Regulation | 21 CFR 872.3920 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
A porcelain tooth is a prefabricated device made of porcelain powder for clinical use (§ 872.6660) intended for use in construction of fixed or removable prostheses, such as crowns and partial dentures.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 39)
Showing 20 most recent of 39 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240586 | Additive Manufacturing Zirconia Customized Restoration | Hangzhou Thales Medtech Co., Ltd. | Oct 3, 2024 | SESE |
| K203072 | Franz Zirconia Dental Crown | Franz Biotech, Inc. | Jan 19, 2022 | SESE |
| K162043 | NobelProcera HT ML FCZ Bridge | Nobel Biocare AB | Nov 22, 2016 | SESE |
| K153534 | NobelProcera HT ML Full Contour Zirconia Crown | Nobel Biocare AB | Jun 6, 2016 | SESE |
| K071182 | PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 | Nobel Biocare AB | Jul 11, 2007 | SESE |
| K060530 | SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302. | Lifecore Biomedical, Inc. | May 22, 2006 | SESE |
| K041283 | PROCERA BRIDGE ZIRCONIA | Nobel Biocare AB | May 28, 2004 | SESE |
| K032562 | PROCEARA COPINGS AND PONTIC | Nobel Biocare AB | Feb 6, 2004 | SESE |
| K965216 | ARGI-SATIN OR OPTI0-STAR | Argen Precious Metals, Inc. | Feb 27, 1997 | SESE |
| K960770 | MATCHMAKER/PROPAQUE PORCELAIN | Davis Schottlander & Davis, Ltd. | Nov 19, 1996 | SESE |
| K960480 | IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013 | Vident | Mar 15, 1996 | SESE |
| K930835 | VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A | Ivoclar North America, Inc. | Jul 22, 1994 | SESE |
| K932012 | CAPS | Chemichl, Inc. | Nov 3, 1993 | SESE |
| K931808 | DUCERAGOLD, DUCERATIN | Degussa AG | Nov 3, 1993 | SESE |
| K924823 | MICRODOSE SILANE | Unicep | Mar 16, 1993 | SESE |
| K924821 | MICRODOSE PORCELAIN ETCHANT | Unicep | Mar 16, 1993 | SESE |
| K923926 | IPS CERAMIC ETCHING GEL | Ivoclar North America, Inc. | Oct 27, 1992 | SESE |
| K920460 | 4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL | Pulpdent Corp. | Apr 28, 1992 | SESE |
| K910569 | TYCERAMIC | Jeneric/Pentron, Inc. | Apr 15, 1991 | SESE |
| K910303 | SYSNPAR PORCELAIN | Jeneric/Pentron, Inc. | Mar 8, 1991 | SESE |
Top Applicants
- Nobel Biocare AB — 5 clearances
- Dentsply Intl. — 5 clearances
- Unicep — 2 clearances
- Shofu Dental Corp. — 2 clearances
- Jeneric/Pentron, Inc. — 2 clearances
