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/productcode/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](/device/K240586.md) | Additive Manufacturing Zirconia Customized Restoration | Hangzhou Thales Medtech Co., Ltd. | Oct 3, 2024 | SESE |
| [K203072](/device/K203072.md) | Franz Zirconia Dental Crown | Franz Biotech, Inc. | Jan 19, 2022 | SESE |
| [K162043](/device/K162043.md) | NobelProcera HT ML FCZ Bridge | Nobel Biocare AB | Nov 22, 2016 | SESE |
| [K153534](/device/K153534.md) | NobelProcera HT ML Full Contour Zirconia Crown | Nobel Biocare AB | Jun 6, 2016 | SESE |
| [K071182](/device/K071182.md) | PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 | Nobel Biocare AB | Jul 11, 2007 | SESE |
| [K060530](/device/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](/device/K041283.md) | PROCERA BRIDGE ZIRCONIA | Nobel Biocare AB | May 28, 2004 | SESE |
| [K032562](/device/K032562.md) | PROCEARA COPINGS AND PONTIC | Nobel Biocare AB | Feb 6, 2004 | SESE |
| [K965216](/device/K965216.md) | ARGI-SATIN OR OPTI0-STAR | Argen Precious Metals, Inc. | Feb 27, 1997 | SESE |
| [K960770](/device/K960770.md) | MATCHMAKER/PROPAQUE PORCELAIN | Davis Schottlander & Davis, Ltd. | Nov 19, 1996 | SESE |
| [K960480](/device/K960480.md) | IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013 | Vident | Mar 15, 1996 | SESE |
| [K930835](/device/K930835.md) | VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP A | Ivoclar North America, Inc. | Jul 22, 1994 | SESE |
| [K932012](/device/K932012.md) | CAPS | Chemichl, Inc. | Nov 3, 1993 | SESE |
| [K931808](/device/K931808.md) | DUCERAGOLD, DUCERATIN | Degussa AG | Nov 3, 1993 | SESE |
| [K924823](/device/K924823.md) | MICRODOSE SILANE | Unicep | Mar 16, 1993 | SESE |
| [K924821](/device/K924821.md) | MICRODOSE PORCELAIN ETCHANT | Unicep | Mar 16, 1993 | SESE |
| [K923926](/device/K923926.md) | IPS CERAMIC ETCHING GEL | Ivoclar North America, Inc. | Oct 27, 1992 | SESE |
| [K920460](/device/K920460.md) | 4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL | Pulpdent Corp. | Apr 28, 1992 | SESE |
| [K910569](/device/K910569.md) | TYCERAMIC | Jeneric/Pentron, Inc. | Apr 15, 1991 | SESE |
| [K910303](/device/K910303.md) | SYSNPAR PORCELAIN | Jeneric/Pentron, Inc. | Mar 8, 1991 | SESE |

## Top Applicants

- Dentsply Intl. — 5 clearances
- Nobel Biocare AB — 5 clearances
- Den-Mat Corp. — 2 clearances
- G-C Intl. Corp. — 2 clearances
- Ivoclar North America, Inc. — 2 clearances

---

**Source:** [https://fda.innolitics.com/productcode/ELL](https://fda.innolitics.com/productcode/ELL)

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