Miscellaneous devices · 21 CFR 872 Subpart G
Intraoral Dental Wax
FDA device type “Wax, Dental, Intraoral”.
- Companies listing it
- 190128 makers
- Brands and models
- 300
- 510(k) clearances
- 250 in five years
- FDA name
- Wax, Dental, Intraoral
510(k) clearances per year, 1976–2026
Companies that list EGD
190 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Mediclus Co., Ltd | South Korea | Maker | Block Out Resin Dual · Ezi-Sep · LC-Resin · The-SEP | 15 | 2026 |
| Aidite (Qinhuangdao) Technology Co., Ltd | China | Maker | Dental Casting · 3D Printing Cast Material | 16 | 2026 |
| GC America Inc. | United States | Maker | GC BITE COMPOUND · SALIVA CHECK | 137 | 2026 |
| Sybron Dental Specialties | United States | Maker | Bite Wafer · Disclosing Wax · Occlusal Indicator Wax | 203 | 2026 |
| Ultradent Products, Inc. | United States | Maker | Gishy Goo | 95 | 2026 |
| Kulzer, LLC | United States | Maker | Modern Materials Bite Blocks · Modern Materials Modern Pink No. 3 · Modern Materials Shur Wax Pink · Modern Materials Shur Wax X-Hard Pink · +9 | 37 | 2026 |
| Prevest Denpro Limited | India | Maker | Hiflex Modelling Wax | 7 | 2024 |
| Ivoclar Vivadent, AG | United States | Maker | Aesthetic Wax | 94 | 2026 |
| Shandong Huge Dental Material Corporation | China | Maker | Casting Wax | 8 | 2026 |
| American Orthodontics | United States | Maker | Debond Wafers · Laminated Bite Wafers · Ortho Wax Bites · Orthodontic Wax | 44 | 2026 |
| Bisco, Inc. | United States | Maker | — | 88 | 2025 |
| Zirkonzahn Srl | Italy | Maker | — | 10 | 2023 |
| Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | Germany | Maker | CAD Waxx · VITA VIONIC WAX | 8 | 2026 |
| Pac-Dent Inc. | United States | Maker | Rodin 3D Resin Try-In | 5 | 2022 |
| Yamahachi Dental Mfg. Co. | Japan | Maker | Bite Rim Sticks · WAX DISK · Yamahachi Parafin Wax | 3 | 2026 |
| Keystone Industries | United States | Maker | Base Plate Wax · Bite Blocks · Mizzy Allcezon Wax · Mizzy Byte Ryte Wax · +3 | 2 | 2025 |
| Hunan Vsmile Biotechnology Co.,Ltd | China | Maker | wax disc | 2 | 2024 |
| Coltene/Whaledent AG | Switzerland | Maker | Boxing Wax · Extra Tough Wax · Hygenic® Bite Wafers · Hygenic® Bite Wafers, Extra, Hard, Green · +11 | 45 | 2022 |
| DIO Corporation | South Korea | Maker | Wax Denture | 14 | 2023 |
| Ortho Organizers, Inc. | United States | Maker | Elastobyte Wafers · Laminated Bite Wafers · Patient Relief Wax · Relief Wafer · +4 | 8 | 2025 |
| New Stetic, SA | Colombia | Maker | Portux 3D Printing Resin Cast | 5 | 2026 |
| Leone S.P.A. | Italy | Maker | Dental wax | 4 | 2025 |
| bredent GmbH & Co. KG | Germany | Maker | — | 3 | 2024 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Orthodontic Wax | 1 | 2025 |
| DENKEN-HIGHDENTAL Co., Ltd. | Japan | Maker | Kolben Wax, Sprue Wax | 1 | 2022 |
| Huliang (shanghai) Bio-Tech Co., Ltd. | China | Maker | Wax Disc | 1 | 2023 |
| Reliance Orthodontic Products, Inc. | United States | Maker | ReliaWax | 32 | 2021 |
| Cavex Holland BV | Netherlands | Maker | Cavex SetUp | 26 | 2015 |
| Prime Dental Manufacturing, Inc. | United States | Maker | APIG Pressure Indicating Gel | 9 | 2012 |
| Merz Dental GmbH | Germany | Maker | PremEco Line set-up wax | 8 | 2017 |
| St. George Technology, Inc. | United States | Maker | Excel Formula Dental Waxes | 4 | 2003 |
| Dentos, Inc. | South Korea | Maker | SF-B · SF-C · SF-P · SF-SET · +2 | 2 | 2019 |
| Integra LifeSciences Corporation | United States | Maker | Beauty Pink · Miltex · Padgett | 2 | 2014 |
| Sunstar Americas, Inc. | United States | Maker | GUM® Ortho Wax + Vitamin E · GUM® Ortho Wax + Vitamin E & Aloe Vera · GUM® Orthodontic Wax +Vitamin E · GUM® Orthodontic Wax Mint with Vitamin E and Aloe Vera | 2 | 2013 |
| Hager Worldwide, Inc. | United States | Maker | Almore Bite Registration Wax and Tabs · Almore Inlay Wax · Almore Margin Wax · Almore Powdered Wax | 2 | 2005 |
| Manufacturera Dental Continental | Mexico | Maker | Calibrated Wax · Rogson Wax | 2 | 2001 |
| GC Orthodontics | United States | Maker | Chewing Aligner · Exerbites · Orthosil | 2 | 2015 |
| Ranir, LLC | United States | Maker | — | 2 | 2011 |
| Sagemax Bioceramics, Inc. | United States | Maker | SAGEWAX · Wax Disc | 2 | 2014 |
| Dental Morelli | Brazil | Maker | — | 2 | 2014 |
| Prestige Brands Holdings, Inc. | United States | Maker | Dentek Wax for Braces | 1 | 2013 |
| Union Dental S.A. | Spain | Maker | IDOWAX · ODIWAX | 1 | 2015 |
| Wright Health Group | United Kingdom | Maker | Dentorium Base Plate | 1 | 2013 |
| YETI Dentalprodukte GmbH | Germany | Maker | — | 1 | 2018 |
| gebdi Dental Products GmbH | Germany | Maker | — | 1 | 2009 |
| Signor Seven International | Pakistan | Maker | Fahnestock Wax Knife and Carver SKU 12-990 · Wax Knives 12 SKU 12-1412 · Wax Knives 6R SKU 12-1406 · Wax Knives 7R SKU 12-1407 · +1 | — | — |
| Dentaurum GmbH & Co. KG | Germany | Maker | Flexaponal special wax · Gumex N · Modeling wax · Protection wax · +2 | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | WAX, DENTAL,INTRAORAL | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Orthodontic Wax | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | Base Plate Wax · occusal rim/wax rim | — | — |
| Scanderra GmbH | Switzerland | Maker | EW-EF25 Expanding Superfloss 25m in blister · EW-EF25 Expanding Superfloss 25m in blister, without Exp Date · EW-PC70 Easy Tape Waxed Dental Tape Caipirinha in blister · EW-PCR250 Easy Tape Waxed Dental Tape Caipirinha Refill 250m · +8 | — | — |
| Endo Tech Instruments | Pakistan | Maker | PK Thomas Wax Instruments set of 5pcs · Wax Spatula D/E | — | — |
| Accompany Surgical | Pakistan | Maker | WAXING INSTRUMENTS | — | — |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | Wax, dental, intraoral | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | wax, dental, intraoral | — | — |
| Great Lakes Dental Technologies, Ltd. | United States | Maker | Great Lakes Bite Registration wax | — | — |
| Denta Craft Instruments | Pakistan | Maker | WAXING INSTRUMENTS | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | WAX, DENTAL, INTRAORAL | — | — |
| Solventum US LLC | United States | Maker | Orthodontic Wax | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | Orthodontic wax, chwey | — | — |
| Digital Age Dental Laboratories, Ltd. | United States | Maker | N/A | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Dental Wax | — | — |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | China | Maker | Orthodontic wax | — | — |
| HuangHua DK Dental Co., LTD, | China | Maker | Dental Wax | — | — |
| Zhejiang Jasmine Oralcare Products Co., Ltd. | China | Maker | Dental Wax | — | — |
| Associated Dental Products Ltd | United Kingdom | Maker | All Season Baseplate Wax · Anutex · Anutex HS · Kemdent · +6 | — | — |
| Henan Baistra Medical Devices Limited | China | Maker | WAX, DENTAL, INTRAORAL | — | — |
| Aadi Med Private Limited | India | Maker | MAARC Base Plate Wax | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Wax, Dental | — | — |
| Maquira Industria de Produtos Odontologicos | Brazil | Maker | Orthodontic Wax | — | — |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | China | Maker | Orthodontic Wax | — | — |
| Erskine Dental | Australia | Maker | Piksters Wax for Orthodontics & Braces | — | — |
| New Phenix Home Products Manufactory Co Ltd | China | Maker | Dr Smith Brand Relief Wax · Lummarx Brand Orthodontic Wax · Oral-Care | — | — |
| Digital Dental Depot Limited | Hong Kong SAR China | Maker | EGD / WAX, DENTAL, INTRAORAL · WAX, DENTAL, INTRAORAL | — | — |
| Shenzhen Golden Wish Personal Care Co.,Ltd | China | Maker | Ortho Wax, OW-01, OW-02, OW-03, OW-04 | — | — |
| Shandong Hengfeng Kerui Medical Equipment Co., Ltd | China | Maker | Orthodontic wax | — | — |
| Shenzhen Sunmc Dental Technology Co., Ltd. | China | Maker | Orthodontic Wax | — | — |
| Ashtel Studios, Inc. | United States | Maker | Brush Buddies, Dental wax | — | — |
| Wuhu Guli Ortho Co.,Ltd | China | Maker | Orthodontic wax | — | — |
| Wellmed Dental Medical Supply Co., Ltd. | China | Maker | WAX, DENTAL, INTRAORAL | — | — |
| Coral Healthcare Products Manufacturer Co., Ltd. | China | Maker | DENTAL WAX, Brand: CORALCLEAN, USOP, SKY DENTAL, ALLURE ORTHO, PLATYPUS, O&S DENTAL; Model: AC01 · DENTAL WAX, Brand: CORALCLEAN, USOP, SKY DENTAL, ALLURE ORTHO, PLATYPUS, O&S DENTAL; Model: D653, S451, S452, S453, DM01 · DENTAL WAX, Brand: CORALCLEAN, USOP, SKY DENTAL, ALLURE ORTHO, PLATYPUS, O&S DENTAL; Model: S815, S811, S951, D600, D603 | — | — |
| Guangzhou Cheer-U Material Technology Co., Ltd | China | Maker | Orthodontic Wax | — | — |
| Jiangsu Province Yangzhou Shuguang Toothbrush Manu | China | Maker | Dental Wax | — | — |
| Zhejiang Mediunion Healthcare Group Co Ltd | China | Maker | Bite Blocks | — | — |
| Atria Co. | South Korea | Maker | Atria | — | — |
| Garreco, LLC. | United States | Maker | Garreco Base Plate Wax Sheets All Season · Garreco Base Plate Wax Sheets Medium Hard · Garreco Base Plate Wax Sheets Medium Soft · PEMACO 2000 INTRAORAL DENTAL WAX · +6 | — | — |
| O&S Dental Inc | United States | Maker | Orthodontic Wax | — | — |
| Shummi Enterprise Co, Ltd | Taiwan | Maker | DENTAL WAX | — | — |
| Dentaco GmbH & Co. KG | Germany | Maker | Boca Bite · Scan Bite | — | — |
| Digital Dental Depot | China | Maker | Wax, Dental, Intraoral | — | — |
| Libral Traders Pvt Ltd | India | Maker | Patient Relief Wax | — | — |
| Sharp Detail Orthodontic Laboratory | United States | Maker | WAX, DENTAL, INTRAORAL | — | — |
| Weihai Jieshi Commodity Manufacture Co., Ltd. | China | Maker | — | — | — |
| Hangzhou PengWu Medical Equipment Co.,Ltd | China | Maker | SmileStreamSolutions / PW Ortho | — | — |
| Yangzhou Royal Home Products Manufacture Co., Ltd. | China | Maker | Wax, Dental, Intraoral | — | — |
| Rosemarie Products Company, LLC | United States | Maker | — | — | — |
| Advanced Dental Designs | United States | Maker | Accu-Bite | — | — |
| Gurunanda LLC | United States | Maker | — | — | — |
| JISCOP Co., Ltd. | South Korea | Maker | Intraoral Dental Wax | — | — |
| Pesitro Healthcare Products Co., Ltd. | China | Maker | GRANULAR ORTHODONTICWAX(PRO);YANDY;90counts;Food-grade wax · YANDY Orthodontic Gel Protection Wax · YANDY Orthodontic Particle Protection Wax (Gel PRO) | — | — |
| Yangzhou Yichuan Plastic Technology Co., Ltd. | China | Maker | dental wax; ortho wax | — | — |
| Chewink Corp. | Taiwan | Maker | Dental wax | — | — |
| Freeman Manufacturing & Supply Co. | United States | Maker | Bite Block · Bite Stick - Concave Side · Corning Bite Blocks · Corning Bite Sticks · +2 | — | — |
| Shenzhen Yongchanghe Technology Co., Ltd. | China | Maker | Dental casting resin | — | — |
| Xiamen Antinsky Industry Co., Ltd | China | Maker | Castable Dental Resin, Castable Dental Smart Resin | — | — |
| Dr. Jean Bausch GmbH & Co. KG | Germany | Maker | Arti-Pink Bite Wax | — | — |
| Ningbo Haishu Zonghai Artware Co., Ltd. | China | Maker | Brace Gard Mini Pak / 79/6DP · Brace Relief Pocket Kit,/ 79/2DP · Brace Relief Pocket Kit,/ 79/DP · Brace Relief Quads · +1 | — | — |
| Placecol S.A. | Colombia | Maker | exempt | — | — |
| Qingdao Jinpuguangyuan Science and Technology Co.,ltd | China | Maker | Toothwax | — | — |
| Sonrisa | United States | Maker | No Stress Impress | — | — |
| Vago International Manufacturing SA DE CV | Mexico | Maker | Gishy Goo | — | — |
| YangZhou ChenXiao Brush Industrial Co., Ltd. | China | Maker | Dental Wax | — | — |
| Arak Dental Lab | United Arab Emirates | Maker | WAX, DENTAL, INTRAORAL | — | — |
| Caribbean Custom Mold Inc | Dominican Republic | Maker | Sonrisa | — | — |
| Jiangsu Bailu Brushes Co., Ltd | China | Maker | dental wax | — | — |
| Natural Esthetics | Germany | Maker | Bite · CR Record · Pre-Adjustment Relaxator | — | — |
| OrVance LLC | United States | Maker | OrVance OrthoDots, OrVance Aligner Pontics | — | — |
| Shenzhen Yuechuan trade Co., Ltd. | China | Maker | Orthodontic Gel Blocks · Othodontic wax | — | — |
| ChangShu ShangChi Dental Materials Co., Ltd. | China | Maker | DENTAL WAX | — | — |
| Wholesale Dental MFG & Supply | United States | Maker | wax | — | — |
| Zinkh NV | Belgium | Maker | Elemental Granulate | — | — |
| Calibaja Manufacturing, S.A. de C.V. | Mexico | Maker | — | — | — |
| J-Energy Daily Care Products Co.,ltd | China | Maker | Dental Wax | — | — |
| BILKIM Co., Ltd | Türkiye | Maker | WAX, DENTAL, INTRAORAL | — | — |
| Carmel Industries | Canada | Maker | Carmel Dental Wax | — | — |
| Memphis Dental MFG. Co., Inc. | United States | Maker | WAX, DENTAL, INTRAORAL | — | — |
| Kent Manufacturing Company | United States | Maker | — | — | — |
| Shen FU Arts Lab | China | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | — | 23 | 2025 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Manufacturer | IMIWAX CEREMONY · NOVAWAX | 5 | 2022 |
| Smylio | United States | Manufacturer | — | 4 | 2026 |
| Tp Orthodontics, Inc. | United States | Manufacturer | WAFERS · WAX STRIPS | 5 | 2022 |
| Riton 3D Technology Co., Ltd | China | Manufacturer | Casting Wax Resin Model C1-G | 1 | 2024 |
| Buffalo Dental Mfg. Co., Inc. | United States | Manufacturer | Buffalo Dental Wax | 11 | 1996 |
| Whip Mix Corporation | United States | Manufacturer | Denar Bite Reg wax | 8 | 2016 |
| G&H Wire Company | United States | Contract manufacturer | N/A | 2 | 2008 |
| Rmo, Inc. | United States | Manufacturer | Patient Relief Wax | 1 | 1990 |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | DENTAL WAX · ORTHODONTIC WAX | — | — |
| Five Star Orthodontic Laboratory & Supply, Inc. | United States | Contract manufacturer | — | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | TOSCANA | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Wax | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Orthodontic Wax | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson® Baseplate Wax | — | — |
| Ortho Pro Dent LLC | United States | Repacker / relabeler | orthodontic wax · Pressure Indicating Gel | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Dental Wax | — | — |
| Practicon, Inc. | United States | Manufacturer | Patient Relief Wax | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| International Orthodontics Services. PC | United States | Repacker / relabeler | Dental Wax | — | — |
| Ortho Arch Company Inc | United States | Repacker / relabeler | Patient Care Kits Patient Relief Wax · Patient Relief Wax | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Wax | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Foreign exporter | WAX,DENTAL,INTRAORAL | — | — |
| Unisource Shanghai Ltd. | China | Foreign exporter | Dental Wax · Orthodontic Wax | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | WAX, DENTAL, INTRAORAL | — | — |
| battech | United States | Repacker / relabeler | dental wax sheet | — | — |
| Maxill Inc. | United States | Foreign exporter | Maxill | — | — |
| Shanghai MU PROMOTIONS Co., Ltd. | China | Foreign exporter | WAX,DENTAL,INTRAORAL | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| Xplora USA LLC | United States | Manufacturer | Six Month Smiles | — | — |
| Specialty Appliances, LLC | United States | Manufacturer | Orthodontic Relief Wax | — | — |
| US Orthodontic Products | United States | Repacker / relabeler | Dental Wax | — | — |
| Meta Dental Corp. | United States | Repacker / relabeler | Textured Wax, Pontic wax, Boxing wax, Bite Registration Wax, | — | — |
| Cordica Medical (Formally Team Technologies, Inc) | United States | Contract manufacturer | — | — | — |
| Axiodent Inc. | United States | Repacker / relabeler | AxioModelling Wax | — | — |
| Orthone INC. | United States | Repacker / relabeler | orthone, Orthodontic wax, Orthodontic Wax | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Tess Oral Health | United States | Manufacturer | Tess Oral Health Relief Wax | — | — |
| Universal Orthodontic Lab, Inc. | United States | Manufacturer | Dental Wax | — | — |
| Tangent Technologies LLC | United States | Contract manufacturer | Patient Relief Wax | — | — |
| Reliable Dental Studio, Inc. | United States | Remanufacturer | Waxrim | — | — |
| Shummi US LLC | United States | Contract manufacturer | WAX, DENTAL, INTRAORAL | — | — |
| Unip Berhad | Malaysia | Contract manufacturer | WAX | — | — |
| Mountain Dental Lab Service Inc | United States | Repacker / relabeler | SHEN FU ARTS LAB | — | — |
| Tender Corporation d/b/a Adventure Ready Brands | United States | Repacker / relabeler | Dental Wax | — | — |
| Upcera Dental America Inc. | United States | Repacker / relabeler | Wax Block | — | — |
| Vermont Manufacturing Services, Inc. | United States | Repacker / relabeler | Adventure Ready Brands | — | — |
| Alta Smiles, Inc | United States | Manufacturer | — | — | — |
| DongGuan JunHai Medical Device Co., Ltd | China | Contract manufacturer | Ortho Wax | — | — |
| Onestopdentalstudio Inc | United States | Repacker / relabeler | RESTORATION, PORCELAIN | — | — |
| Bird-X, Inc. | United States | Manufacturer | All Season, Red Refined, Rijform, Set Rite | — | — |
| IPB Inc | United States | Contract manufacturer | Dental Wax | — | — |
| Opa Dental, LLC | United States | Repacker / relabeler | — | — | — |
| BND Limited | Hong Kong SAR China | Foreign exporter | Intraoral Dental Wax | — | — |
| Aid United International Co., Limited | China | Foreign exporter | — | — | — |
| Gda Marketing Limited | Hong Kong SAR China | Foreign exporter | DENTEK WAX | — | — |
| Zhangjiagang Alldex Commodity Co. Ltd | China | Private-label distributor | WAX, DENTAL, INTRAORAL | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Gestion Boucher/Durette | Canada | Repacker / relabeler | Hard Inlay Wax | — | — |
| J.M. Murray Center, Inc. | United States | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 11 Feb 2002 | K020009 | BRACE EZE | Udent, Inc. |
| 27 Jan 1995 | K945535 | GLENROE ORTHO-SIL | Glenroe Technologies |
| 17 Nov 1992 | K924024 | ORTHO WAX | Heraeus Kulzer, LLC |
| 29 Sep 1992 | K923586 | BURNOUT MATERIAL | Dentsply Intl., Inc. |
| 2 Sep 1992 | K914892 | SALIVA-STIM | Orion Diagnostica, Inc. |
| 16 Jun 1992 | K922380 | BITE RIM WAX | Dentsply Intl., Inc. |
| 19 Mar 1992 | K914513 | PALAVIT G | Heraeus Kulzer, LLC |
| 21 Aug 1991 | K910676 | INTRAORAL DENTAL WAX | Pemaco, Inc. |
| 6 Jun 1991 | K904928 | PALAVIT GLC | Kulzer, LLC |
| 6 Nov 1989 | K895566 | PEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFT | Pemaco, Inc. |
| 6 Nov 1989 | K895564 | PEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARD | Pemaco, Inc. |
| 6 Nov 1989 | K895563 | PEMACO BITE WAX SHEETS | Pemaco, Inc. |
| 6 Nov 1989 | K895562 | PEMACO 2000 INTRAORAL DENTAL WAX | Pemaco, Inc. |
| 6 Nov 1989 | K895561 | PEMACO 3000 INTRAORAL DENTAL WAX | Pemaco, Inc. |
| 24 Oct 1989 | K895565 | PEMACO ECONOMY BASE PLATE WAX-MEDIUM HARD | Pemaco, Inc. |
| 31 Mar 1988 | K880607 | UTILITY WAX STRIPS, SPEARMINT | Columbus Dental Mfg. Co. |
| 24 Mar 1988 | K880606 | UTILITY WAX STRIPS, CINNAMON | Columbus Dental Mfg. Co. |
| 7 Oct 1986 | K863758 | ORTHO-BITE WAX WAFER | Columbus Dental Mfg. Co. |
| 10 Mar 1986 | K854529 | INLAY WAX REGULAR | The Hygenic Company, LLC |
| 4 Mar 1986 | K854530 | PREMIUM FLEXI-TOUGH | The Hygenic Company, LLC |
| 4 Mar 1986 | K854527 | STICKY WAX | The Hygenic Company, LLC |
| 16 Apr 1985 | K850915 | WAX BITE IMPRESSION WAFER | Toothprints, Inc. |
| 26 Jan 1982 | K812804 | MODERN MATERIALS' INLAY CSTG. WAXES,A-C | Modern Materials |
| 12 Jan 1982 | K812805 | STEELE'S ECON. PINK BASEPL. WAXES, I-III | Modern Materials |
| 27 Aug 1980 | K801911 | HOWMEDICA BITE BLOCK | Howmedica Corp. |
Official records: FDA product classification for EGD · 21 CFR 872.6890.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026