Dental Device Guide
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Prosthetic devices · 21 CFR 872 Subpart D

Porcelain Teeth

FDA device type “Teeth, Porcelain”.

FDA codeELLClass221 CFR872.3920Pathway510(k)CategoryDental ceramics & zirconia
Companies listing it
2214 makers
Brands and models
29
510(k) clearances
392 in five years
FDA name
Teeth, Porcelain
1977: 11978: 11980: 11982: 11984: 21985: 21986: 11987: 21988: 41989: 21990: 21991: 21992: 21993: 41994: 11996: 21997: 12004: 22006: 12007: 12016: 22022: 12024: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list ELL

22 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Nobel Biocare Services AGSwitzerlandMakerNobelProcera Zirconia Bridge · NobelProcera Zirconia Crown942026
Shofu IncJapanMakerANTI-GREENING LIQUID · VINTAGE PAINT OPAQUE LIQUID - 50mL · VINTAGE PORCELAIN962025
GC America Inc.United StatesMakerWILLI GELLER CREATION CP PORCELAIN1372026
Ivoclar Vivadent, AGUnited StatesMakerBonartic CT · Physioset CT · SR Vivoperl942026
Paltop Advanced Dental Solutions Inc.United StatesMakerPrimaConnex CAD/CAM Abutment System72025
Premier Dental Products CompanyUnited StatesMakerPorcelain Silane282026
Keystone Dental Inc.United StatesMakerGenesis Dental Implant System · MAX-TL Dental Implant System · PrimaConnex Cad/Cam Abutment System72024
Vita Zahnfabrik H. Rauter GmbH & Co. Kg.GermanyMakerAlumina Blanks Spinell Blanks Spinell Optimizer Alumina Optimizer In-Ceram Zirconia82026
Hangzhou Thales Medtech Co., Ltd.ChinaMakerAdditive Manufacturing Zirconia Customized Restoration12024
China Dental Outsourcing IncChinaMakerPORCELAIN——
Shenzhen Jiahong Dental Technology Co., LtdChinaMakerELL——
HO Chi Minh Branch - Vatech Viet Joint Stock CompanyVietnamMakerLithium disilicate Emax/Lisi crown · Lithium disilicate Emax/Lisi inlay and onlay · Lithium disilicate veneer——
Silgan UnicepUnited StatesMaker———
Dental Laboratory Milling Supplies LLC, DBA Digital Dental,United StatesMaker———
Jensen Industries, Inc.United StatesManufacturer—172019
TitanLinks Logistics LLCUnited StatesRepacker / relabelerTooth bond——
Soher Med LimitedHong Kong SAR ChinaForeign exportertooth bond——
DDS DentalabUnited StatesRepacker / relabelerEMPRESS · OPC · PROCERA · ZIRCONIA——
Arvit Dental Laboratory Inc.United StatesRepacker / relabelerTeeth, Porcelain——
Global Dental Technologies, Inc.United StatesRepacker / relabelerArtificial Teeth——
TD Dental Supply, Inc.United StatesRepacker / relabeler———
Oketz Logistics LLCUnited StatesRepacker / relabeler———

510(k) clearances

Decided510(k)DeviceApplicant
3 Oct 2024K240586Additive Manufacturing Zirconia Customized RestorationHangzhou Thales Medtech Co., Ltd.
19 Jan 2022K203072Franz Zirconia Dental CrownFranz Biotech, Inc.
22 Nov 2016K162043NobelProcera HT ML FCZ BridgeNobel Biocare Services AG
6 Jun 2016K153534NobelProcera HT ML Full Contour Zirconia CrownNobel Biocare Services AG
11 Jul 2007K071182PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013Nobel Biocare Services AG
22 May 2006K060530SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.Lifecore Biomedical, Inc.
28 May 2004K041283PROCERA BRIDGE ZIRCONIANobel Biocare Services AG
6 Feb 2004K032562PROCEARA COPINGS AND PONTICNobel Biocare Services AG
27 Feb 1997K965216ARGI-SATIN OR OPTI0-STARArgen Precious Metals, Inc.
19 Nov 1996K960770MATCHMAKER/PROPAQUE PORCELAINDavis Schottlander & Davis, Ltd.
15 Mar 1996K960480IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013Vident
22 Jul 1994K930835VIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP AIvoclar North America, Inc.
3 Nov 1993K932012CAPSChemichl, Inc.
3 Nov 1993K931808DUCERAGOLD, DUCERATINDegussa AG
16 Mar 1993K924823MICRODOSE SILANEUnicep
16 Mar 1993K924821MICRODOSE PORCELAIN ETCHANTUnicep
27 Oct 1992K923926IPS CERAMIC ETCHING GELIvoclar North America, Inc.
28 Apr 1992K9204604% ACIDULATED PHOSPHATE FLUORIDE ETCHING GELPulpdent Corporation
15 Apr 1991K910569TYCERAMICJeneric/Pentron, Inc.
8 Mar 1991K910303SYSNPAR PORCELAINJeneric/Pentron, Inc.
9 Nov 1990K903907PROCERAM PORCELAINNobelpharma USA, Inc.
22 Feb 1990K895269DEN-MAT LAMI-QUICKDen-Mat Corp.
14 Jul 1989K893481CRYSTAR(TM) ANTI-GREENING LIQUIDShofu Inc
14 Jul 1989K892806TUF-COATG-C Intl. Corp.
8 Dec 1988K884214CRYSTAR(TM) VINTAGE PORCELAINShofu Inc
18 May 1988K880774SPECTRUMDentsply Intl., Inc.
12 Apr 1988K880764G-CERA PORCELAIN & G-CERA PORCELAIN MODIFIERG-C Intl. Corp.
18 Mar 1988K875351DEN-MAT PORETCH (PORCELAIN ETCHANT)Den-Mat Corp.
5 Jun 1987K871808DUCERAM-METAL-CERAMIC DENTAL PORCELAIN SYSTEMDegussa Dental, Inc.
17 Feb 1987K864724MODI. OF DENTAL CERAMIC FOR FABRICATION OF CROWNDentsply Intl., Inc.
26 Mar 1986K860608ARTIFICIAL TEETH, PORCELAIN, MODIFIEDDentsply Intl., Inc.
16 Oct 1985K851733DENTAL PORCELAIN-VARIOUSExcelco Intl., Inc.
2 Jul 1985K852145CAPA PRE-FORMED PORCELAIN CROWNCapa Industries
12 Jul 1984K841826NATURA-DENT VACUUM-FIRED PORCELAIN TEETHParexel Intl. Corp.
30 Mar 1984K840642THERMOCRAFT PORCELAINAmerican Thermocraft Corp.
28 Dec 1982K823744PORCELAIN ARTIFICIAL TEETHDentsply Intl., Inc.
8 May 1980K800829MYERSON R&KENSON R PORCELAIN ANT&POS.-Myerson Tooth Corp.
20 Dec 1978K781935NU-GLAZEDeringer-Ney, Inc.
15 Jul 1977K771179BIOBOND MASTER STAIN AND GLAZE KITDentsply Intl., Inc.

Official records: FDA product classification for ELL · 21 CFR 872.3920.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026