Prosthetic devices · 21 CFR 872 Subpart D
Preformed Crown
FDA device type “Crown, Preformed”.
- Companies listing it
- 12684 makers
- Brands and models
- 355
- 510(k) clearances
- 90 in five years
- FDA name
- Crown, Preformed
510(k) clearances per year, 1976–2026
Companies that list ELZ
126 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | Atlantis Temp Crown | 148 | 2026 |
| BioHorizons Implant Systems, Inc. | United States | Maker | BIOHORIZONS COMFORT CAP | 41 | 2026 |
| Hass Corp. | South Korea | Maker | ZIRKIZ | 6 | 2026 |
| Yamahachi Dental Mfg. Co. | Japan | Maker | Weldenz | 3 | 2026 |
| Dentium USA | United States | Maker | TSA2-FS · TSTR-FS | 23 | 2022 |
| NuSmile, Ltd. | United States | Maker | NuSmile BioFlx Crowns · NuSmile Pediatric Crowns · NuSmile Pre-Contoured Stainless Steel Crowns (SSC) · NuSmile ReVIVE Crowns · +2 | 2 | 2026 |
| Shinhung Company, Ltd. | South Korea | Maker | ALU CROWN · KIDS CROWN · KIDS GOLDEN CROWN, KIDS RING CROWN, KIDS ZIRCONIA CROWN TRY-IN · KIDS ZIRCONIA CROWN · +4 | 2 | 2023 |
| edelweiss dentistry products gmbh | Austria | Maker | Ceramir Pediatric Crown 51/E Size L · Ceramir Pediatric Crown 51/E Size M · Ceramir Pediatric Crown 51/E Size S · Ceramir Pediatric Crown 51/E Size XL · +159 | 1 | 2024 |
| Ceraroot SL | Spain | Maker | TempCrown, Healing Rings, CeraRoot | 1 | 2025 |
| Kids-E-Dental LLP | India | Maker | Bioflx Crown · Kids-e-crown · Kids-e-SSC | 1 | 2024 |
| Creodent Hudson Valley | United States | Maker | CreoZ | 1 | 2026 |
| Sprig Oral Health Technologies, Inc. | United States | Maker | Sprig Oral Health Technologies, Inc. | 1 | 2023 |
| Prime Dental Manufacturing, Inc. | United States | Maker | Prime-Crown | 9 | 2012 |
| Basic Dental Implant Systems, Inc. | United States | Maker | EMERGENCE PROFILER | 6 | 2008 |
| Peng Lim Enterprise Co., Ltd. | Taiwan | Maker | KID CROWN | 2 | 2006 |
| Qinhuangdao Audental Metal Technology Co., Ltd. | China | Maker | CROWN, PREFORMED | 1 | 2020 |
| Directa AB | Sweden | Maker | Ceramir Pediatric Crown · CoForm · Crown Forms · Directa Polycarbonate Crowns · +3 | 1 | 2015 |
| Seilglobal CO., Ltd | South Korea | Maker | Primary Crown | 1 | 2015 |
| Royal Dental Laboratory | China | Maker | CROWN, PREFORMED | 1 | 2020 |
| TDV Dental Ltda | Brazil | Maker | ANTERIOR CROWNS · DECIDUOUS CROWNS · POSTERIOR CROWNS | — | — |
| Denovo Dental Inc | United States | Maker | D071514 · D071515 · D071516 · D071517 · +4 | — | — |
| Solventum US LLC | United States | Maker | CROWN | — | — |
| Nanjing Chamlion Laser Technology Co., Ltd. | China | Maker | Metal Crown | — | — |
| Produits Dentaires SA | Switzerland | Maker | Odus Pella Transparent Crown Forms · Pella Transparent Crown Forms | — | — |
| one day dental partner | South Korea | Maker | kage CROWN, PREFORMED | — | — |
| D&S Dental Laboratory | United States | Maker | E-MAX ANTERIOR ALL CERAMIC CROWN · E-MAX ANTERIOR ALL CERAMIC CROWN SCAN · E-MAX POSTERIOR ALL-CERAMIC CROWN · E-MAX POSTERIOR ALL-CERAMIC CROWN SCAN · +20 | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Dental crown | — | — |
| Svenska Dentorama AB | Sweden | Maker | DENTORAMA CELLULOID CROWN FORMS · DENTORAMA POLYCARBONATE CROWNS | — | — |
| Specialty Appliances, LLC | United States | Maker | — | — | — |
| Viarden Lab LLC | United States | Maker | VIARDEN LAB PRE-MADE CROWNS | — | — |
| Shenzhen Sunmc Dental Technology Co., Ltd. | China | Maker | Acrylic Denture · Dental Crown · Full Metal Crown · Implant Crown · +1 | — | — |
| Improve Co.,limited | Hong Kong SAR China | Maker | CROWN, PREFORMED · Plaster Models Including mixed Material · Porcelain fused to metal crown/bridges, zirconia crown/bridges, E.max crownbridge | — | — |
| Changsha Easyinsmile Intelligence Technology Co.,Ltd. | China | Maker | Dental Crown | — | — |
| SKY DENT Corp for dental trading | United States | Maker | SKY DENT KIDS CROWNS - 1DERFUL KIDS CROWNS | — | — |
| Aurum Group Ltd. | Canada | Maker | CROWN · DENTAL PROSTHESIS | — | — |
| HyperCert Limited | United States | Maker | Prefabricated Crown | — | — |
| Dxin Trading HK Co., Limited | China | Maker | E.max crown/bridge · Porcelain fused to metal crown/bridges · zirconia crown/bridges | — | — |
| Fseven Dental Technology Zhuhai Co.,ltd | China | Maker | Plaster Models,Including Mixed material,Products with Gypsum as the main component | — | — |
| Huile Denture Technology (Hong Kong) Co Limited | China | Maker | E.max crown/bridge · Porcelain fused to metal crown/bridges · zirconia crown/bridges | — | — |
| J C India | India | Maker | Rainbow preformed Gold primary and permanent crowns · Rainbow preformed Rose gold primary and permanent crowns · Rainbow preformed ZR crowns | — | — |
| Hangzhou DTC Medical Apparatus Co., Ltd | China | Maker | Stainless Steel crown | — | — |
| Zhejiang YO Medical Technology Co., Ltd | China | Maker | Dental Crown; Crown, Preformed | — | — |
| Smilden Biotechnology CO., Ltd. | Taiwan | Maker | Crown, Performed | — | — |
| IDS Korea | South Korea | Maker | Dentsply · E-MAX Crown · Porcelain Fused to Metal Crown · Ticonium | — | — |
| Park Istre LLC | United States | Maker | Acero 3S Crowns · Acero ES Crowns · Acero ESL Crowns · Acero Narrow NA Crowns · +3 | — | — |
| Preferred Oral Design Limitada | Costa Rica | Maker | CROWN, PREFORMED | — | — |
| White Bite, Inc. | United States | Maker | Flex Crown · Matrix Band · Pedo Jacket · Strip Crown | — | — |
| Crown Trading (HK) Co., Limited | China | Maker | Dental Crown, PFM Crown, Full Metal Crown, Implant Crown, Acrylic Denture | — | — |
| Foo Tian Dental Laboratory | China | Maker | Fixed Restorations like dental crowns&bridges,post core, inlay or onlay, Zirconia crown or bridge, monolithic Zirconia, | — | — |
| VIVI Dental Laboratory | China | Maker | Dental Crown, PFM Crown, Full Metal Crown, Implant Crown, Acrylic Denture | — | — |
| Arak Dental Lab | United Arab Emirates | Maker | Artificial teeth | — | — |
| F-Six Dental Technology Co.,limited | Hong Kong SAR China | Maker | Plaster Models,Including mixed material,products with gypsum as the main component,Plaster models | — | — |
| Innovaid Co. | South Korea | Maker | Dentlink Zirconia Crown | — | — |
| Istar dental lab | China | Maker | Porcelain Fused To Metal Crown/Bridge; Zirconia Crown/Bridge; Emax Crown/Bridge: Anterior and Posterior | — | — |
| Laxmi Dental Limited | India | Maker | — | — | — |
| Topway Dental Laboratory Co., Ltd | China | Maker | Preformed Crown | — | — |
| Dentall, Inc. | China | Maker | Dentalle Zirconia Cown | — | — |
| DSC Dental, LLC | United States | Maker | DSC Dental | — | — |
| Peter Cheng Orthodontic Laboratories, Inc. | United States | Maker | Cheng Crowns Classic · Cheng Crowns Pediatric Crowns · Cheng Crowns Zirconia | — | — |
| Wholesale Dental MFG & Supply | United States | Maker | CROWN | — | — |
| Crown Makers | South Korea | Maker | CM-202401 | — | — |
| frasaco GmbH | Germany | Maker | STRIP CROWN FORMS | — | — |
| Monde Dental Lab | China | Maker | Porcelain crown | — | — |
| RB Dental | South Korea | Maker | Dental Crown · Porcelain Fused to Metal Crown | — | — |
| Reach Global India Pvt Ltd | India | Maker | Little crown | — | — |
| Shenzhen Jinyi Medical Technology Co.,Ltd | China | Maker | Temporary Crown | — | — |
| Apex Dental Laboratory Group, LLC | United States | Maker | preformed pediatric crown | — | — |
| Artistic Dental Lab, Inc. | United States | Maker | CROWN | — | — |
| Aurum Classic Ltd. | Canada | Maker | — | — | — |
| COHO Advanced Materials Tech. Co., Ltd. | Taiwan | Maker | — | — | — |
| Gaju Dental Inc. | South Korea | Maker | Preformed Crown | — | — |
| Mei Mei Min Beijing Technology | China | Maker | KTR Crowns | — | — |
| Ocean Ceramics | Canada | Maker | — | — | — |
| Pono Labs Private Limited | Nepal | Maker | Custom dental crowns | — | — |
| Quality Tech Services, LLC | United States | Maker | — | — | — |
| Smileconcept Dental Lab | South Korea | Maker | ZIRCONIA CROWN | — | — |
| Xdent Lab Co. Ltd | Vietnam | Maker | Crown, preformed | — | — |
| Yes Dental Lab | South Korea | Maker | Dental prosthesis | — | — |
| Cerlucent, LLC | United States | Maker | — | — | — |
| ComDel Innovation, LLC | United States | Maker | — | — | — |
| FIMA-CouronneTEC GmbH & Co. KG | Germany | Maker | — | — | — |
| Shenzhen Hongqin Mold Co., Ltd. | China | Maker | — | — | — |
| Uscn Sourcing, LLC | United States | Maker | — | — | — |
| Zelia Dental Lab LLC | United States | Maker | — | — | — |
| Parkell, Inc | United States | Contract manufacturer | — | 58 | 2025 |
| CreoDent Prosthetics LTD | United States | Repacker / relabeler | Crown | 9 | 2022 |
| Hu-Friedy Mfg Co., LLC | United States | Contract manufacturer | Hu-Friedy Stainless Steel Crowns · PEDO Crowns · Zirconia Crowns | 8 | 2012 |
| Temrex Corp. | United States | Manufacturer | Crown Forms | 2 | 2012 |
| National Dentex LLC | United States | Contract manufacturer | Preformed Crown | 1 | 2012 |
| Jersey Dental Supplies | United States | Repacker / relabeler | CROWN, PREFORMED | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Crown | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Preformed Crown | — | — |
| Ortho Pro Dent LLC | United States | Repacker / relabeler | Devon-Crown | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Crowns | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Kids Crowms | — | — |
| Premium Plus Dental | United States | Lister | — | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | MARK3 Polycarbonate Crowns · MARK3® Stainless Steel Crowns | — | — |
| HI Medical Co., Ltd. | South Korea | Foreign exporter | 3M ESPE | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Zapalign LLC | United States | Repacker / relabeler | — | — | — |
| Zapalign Inc. | South Korea | Foreign exporter | CROWN, PREFORMED | — | — |
| Chung Song Industrial Co. | South Korea | Foreign exporter | SUNBURST | — | — |
| DigiSmiles Lab | United States | Repacker / relabeler | Crown Preformed | — | — |
| Libodent Inc. | United States | Repacker / relabeler | Full metal crown · IPS E.max · PFG · PFM · +1 | — | — |
| Prais Reliable Dental Supplies S.A | Seychelles | Foreign exporter | — | — | — |
| Showcase Dental Lab LLC | United States | Contract manufacturer | Preformed Crown, Crown, Porcelain Crown | — | — |
| Efficient Dental Technologies LLC | United States | Repacker / relabeler | EZ-CROWN · NU-CORE · NU-CROWN · PedoNatural Crown | — | — |
| Damore Dental Lab LLC | United States | Repacker / relabeler | crown | — | — |
| Dentac, LLC | United States | Repacker / relabeler | Crown · dentac crown | — | — |
| Fire Dental Studio, LLC | United States | Repacker / relabeler | FIRE ELZ-Crown, Preformed | — | — |
| Hongkong Loyal Beauty Technology Limited | Hong Kong SAR China | Foreign exporter | CROWN, PREFORMED | — | — |
| Kelsey Dental LLC | United States | Specification developer | Prefabricated Crown | — | — |
| Gregory Weil Dental Ceramic Studio, Inc. | United States | Repacker / relabeler | Crown | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| CeraMax Dental Art, LLC | United States | Repacker / relabeler | Crown, Preformed | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| LG Management Dental Lab, Inc. | United States | Repacker / relabeler | — | — | — |
| Northwest Dental | United States | Repacker / relabeler | Denture | — | — |
| A.D.L. Dental Lab | United States | Repacker / relabeler | — | — | — |
| Dylan Lucas International Inc | Canada | Foreign exporter | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Pacific Dental Services | United States | Repacker / relabeler | — | — | — |
| Veenak International Limited | United Kingdom | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 29 Jun 2009 | K091362 | CERAMIC PEDATRIC PREFORMED CROWN | Ez-Pedo, Inc. |
| 22 Jul 1994 | K932759 | TEMPOARY POLYCARBONATE CROWNS | South American Dental Exporting Corp. |
| 21 Jul 1993 | K931352 | PEDO JACKETS OR PJ'S | George M. Wilson, Dds |
| 30 Sep 1991 | K913152 | WHITER BITER CROWN | George M. Wilson, Dds |
| 16 Sep 1991 | K912686 | WHITER BITER CROWN | George M. Wilson, Dds |
| 6 Jun 1989 | K892893 | SDI POLYCARBONATE CROWN, SCHEIN'S | Svenska Dental Instruments AB |
| 16 Sep 1988 | K883325 | PERFORMED CROWN (STAINLESS STEEL) | Whitecap Dental Co. |
| 15 Jul 1977 | K771128 | NEKO CERAMIC CONVENIENCE CROWNS | Sterndent Corp. |
| 26 Apr 1977 | K770684 | CROWN, ACRYLIC, CORAL BRAND, PREFORMED | Parker Laboratories, Inc. |
Official records: FDA product classification for ELZ · 21 CFR 872.3330.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026