Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3920](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3920) → ELL — Teeth, Porcelain # ELL · Teeth, Porcelain _Dental · 21 CFR 872.3920 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL ## Overview - **Product Code:** ELL - **Device Name:** Teeth, Porcelain - **Regulation:** [21 CFR 872.3920](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3920) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **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](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K240586.md) | Additive Manufacturing Zirconia Customized Restoration | Hangzhou Thales Medtech Co., Ltd. | Oct 3, 2024 | SESE | | [K203072](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K203072.md) | Franz Zirconia Dental Crown | Franz Biotech, Inc. | Jan 19, 2022 | SESE | | [K162043](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K162043.md) | NobelProcera HT ML FCZ Bridge | Nobel Biocare AB | Nov 22, 2016 | SESE | | [K153534](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K153534.md) | NobelProcera HT ML Full Contour Zirconia Crown | Nobel Biocare AB | Jun 6, 2016 | SESE | | [K071182](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K071182.md) | PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 | Nobel Biocare AB | Jul 11, 2007 | SESE | | [K060530](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K060530.md) | 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](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K041283.md) | PROCERA BRIDGE ZIRCONIA | Nobel Biocare AB | May 28, 2004 | SESE | | [K032562](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K032562.md) | PROCEARA COPINGS AND PONTIC | Nobel Biocare AB | Feb 6, 2004 | SESE | | [K965216](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K965216.md) | ARGI-SATIN OR OPTI0-STAR | Argen Precious Metals, Inc. | Feb 27, 1997 | SESE | | [K960770](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K960770.md) | MATCHMAKER/PROPAQUE PORCELAIN | Davis Schottlander & Davis, Ltd. | Nov 19, 1996 | SESE | | [K960480](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K960480.md) | IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013 | Vident | Mar 15, 1996 | SESE | | [K930835](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K930835.md) | VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A | Ivoclar North America, Inc. | Jul 22, 1994 | SESE | | [K932012](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K932012.md) | CAPS | Chemichl, Inc. | Nov 3, 1993 | SESE | | [K931808](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K931808.md) | DUCERAGOLD, DUCERATIN | Degussa AG | Nov 3, 1993 | SESE | | [K924823](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K924823.md) | MICRODOSE SILANE | Unicep | Mar 16, 1993 | SESE | | [K924821](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K924821.md) | MICRODOSE PORCELAIN ETCHANT | Unicep | Mar 16, 1993 | SESE | | [K923926](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K923926.md) | IPS CERAMIC ETCHING GEL | Ivoclar North America, Inc. | Oct 27, 1992 | SESE | | [K920460](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K920460.md) | 4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL | Pulpdent Corp. | Apr 28, 1992 | SESE | | [K910569](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K910569.md) | TYCERAMIC | Jeneric/Pentron, Inc. | Apr 15, 1991 | SESE | | [K910303](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL/K910303.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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