Registered with FDA
Zapalign LLC
Fort Lauderdale, FL, United States. Lists 34 dental device types with FDA across 1 registered establishment.
- Device types listed
- 34
- Brands and models
- 12
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Zapalign LLC currently lists, by FDA device type, with the brand and model names on the listing.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Zapalign LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: 3M Company (8), 3M Espe Dental Products (6), Dentsply Sirona, Inc. (4), 3M Deutschland GmbH (3), W&H Dentalwerk Buermoos GmbH (3), 3M Espe AG Dental Products (3), Kulzer, LLC (2), Satelec - Acteon Group (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 Mar 2026 | K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Kulzer, LLC | EBF Resin Tooth Shade Material |
| 13 Jun 2022 | K221695 | 3M Filtek Supreme Flowable Restorative | 3M Company Espe Dental Products | EBF Resin Tooth Shade Material |
| 20 Nov 2019 | K191865 | SmartLite Pro Modular LED Curing Light | Dentsply Sirona, Inc. | EBZ Ultraviolet Activator for Polymerization |
| 31 Oct 2019 | K192961 | ADH19 | 3M Deutschland GmbH | KLE Resin Tooth Bonding Agent |
| 29 May 2019 | K191122 | 3M RelyX Pediatric Resin Modified Glass Ionomer Cement | 3M Espe Dental Products | EMA Dental Cement |
| 2 Jan 2019 | K183476 | 3M Filtek Universal Restorative | 3M Espe Dental Products | EBF Resin Tooth Shade Material |
| 28 Nov 2016 | K163207 | Filtek One Bulk Fill Restorative | 3M Company | EBF Resin Tooth Shade Material |
| 13 Apr 2016 | K153174 | Ketac Universal Aplicap | 3M Deutschland GmbH | EMA Dental Cement |
| 23 Nov 2015 | K143704 | Advanced Air System | W&H Dentalwerk Buermoos GmbH | EFB Dental Air-Powered Handpiece |
| 7 Jul 2015 | K150933 | iBond Universal & iBond Ceramic Primer | Heraeus Kulzer, LLC (Mitsui Chemicals Group) | KLE Resin Tooth Bonding Agent |
| 8 May 2014 | K141081 | FILTEK BULK FILL POSTERIOR RESTROATIVE | 3M Espe Dental Products | EBF Resin Tooth Shade Material |
| 11 Mar 2014 | K132322 | NEWTRON P5 XS B.LED | Satelec - Acteon Group | ELC Ultrasonic Scaler |
| 30 May 2013 | K131404 | FLASH AR PENTA / FLASH AR PENTA QUICK | 3M Deutschland GmbH | ELW Impression Material |
| 17 May 2013 | K130647 | XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML | Heraeus Kulzer, LLC | ELW Impression Material |
| 19 Mar 2012 | K120453 | FILTEK BULK FILL FLOWABLE RESTORATIVE | 3M Espe Dental Products | EBF Resin Tooth Shade Material |
| 13 Feb 2012 | K113406 | AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL | Dentsply International, Inc. | ELW Impression Material |
| 3 Jun 2011 | K110508 | SUGLUE-10 | 3M Espe AG | EMA Dental Cement |
| 19 May 2011 | K110302 | ADHESIVE EXL-759 | 3M Espe AG | KLE Resin Tooth Bonding Agent |
| 2 Jun 2010 | K100756 | MALTA | 3M Espe AG Dental Products | EMA Dental Cement |
| 12 May 2010 | K100235 | FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE | 3M Company | EBF Resin Tooth Shade Material |
| 8 Apr 2010 | K094007 | UNICEM | 3M Espe AG Dental Products | EMA Dental Cement |
| 26 Aug 2008 | K081903 | XIOS PLUS WALL-MODULE | Dentsply Sirona, Inc. | MUH Digital Extraoral Source X-Ray System |
| 29 Jul 2008 | K080939 | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES | W&H Dentalwerk Buermoos GmbH | KMW Rotary Bone Cutting Handpiece |
| 17 Jan 2008 | K073395 | GILB-2, GLASS IONOMER PROTECTIVE COATING | 3M Espe Dental Products | EMA Dental Cement |
| 25 Oct 2006 | K062292 | UNICEM | 3M Espe Dental Products | EMA Dental Cement |
| 15 Dec 2004 | K043131 | TORPICALGIN | Dentsply Sirona, Inc. | ELW Impression Material |
| 16 Jun 2004 | K040906 | CALIBRA CEMENT | Dentsply Intl., Inc. | EMA Dental Cement |
| 21 Oct 2003 | K032465 | MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI | Satelec | EBZ Ultraviolet Activator for Polymerization |
| 11 Aug 2003 | K032001 | POLY Q (GARANT L, PENTA M, PENTA H) | 3M Espe AG Dental Products | ELW Impression Material |
| 5 Oct 2001 | K012505 | SOPRO595 INTRA ORAL CAMERA | Satelec - Acteon Group | EIA Operative Dental Unit |
| 28 Jun 2001 | K011061 | SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11 | W&H Dentalwerk Buermoos GmbH | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 28 Sep 2000 | K002452 | 3M RELY X VENEER CEMENT TRY-IN PASTER | 3M Company | EMA Dental Cement |
| 3 Jan 2000 | K994251 | KETAC-MOLAR QUICK | Espe Dental AG | EBF Resin Tooth Shade Material |
| 8 Sep 1999 | K992897 | IMPREGUM PENTA | Espe Dental AG | ELW Impression Material |
| 5 Jun 1998 | K973201 | PROVI CEMENT | S & C Polymer GmbH | EMA Dental Cement |
| 21 May 1998 | K981091 | NEOCOLLOID, ORTHOPRINT | Dentsply Sirona, Inc. | ELW Impression Material |
| 11 Apr 1997 | K970123 | DENTSPLY CAVITRON SPS SCALER SYSTEM | Dentsply Intl., Inc. | ELC Ultrasonic Scaler |
| 7 Oct 1996 | K962812 | GLUMA DESENSITIZER/GLUMA 3 PRIMER | Heraeus Kulzer, LLC | KLE Resin Tooth Bonding Agent |
| 18 Jul 1996 | K962065 | 3M VITREBOND LIGHT CURE GLASS IONOMER/BASE | 3M Company | EMA Dental Cement |
| 15 Mar 1996 | K960547 | DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE | Espe GmbH & Co. Kg. | ELW Impression Material |
| 5 Jan 1994 | K933139 | 3M VITREMER LUTING CEMENT | 3M Company | EMA Dental Cement |
| 18 Jun 1993 | K925027 | PHOTAC-FIL APLICAP | Espe GmbH (Us) | EMA Dental Cement |
| 20 Mar 1992 | K920424 | SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM | 3M Company | KLE Resin Tooth Bonding Agent |
| 17 Jun 1991 | K911842 | 3M LUTING CEMENT, PASTE A AND B | 3M Company | EMA Dental Cement |
| 16 Jun 1989 | K892452 | PALASEAL(R) | Kulzer, LLC | EBI Rebasing Repairing Relining Denture Resin |
| 1 Mar 1988 | K875133 | CAVIT-W | Espe GmbH (Us) | EBG Resin Temporary Crown and Bridge |
| 18 Mar 1980 | K800485 | VINYL POLYSILOXANE IMPRESSION MATERIAL | 3M Company | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ZAPALIGN LLCFDA reg. 3043226252 | Fort Lauderdale, FL, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10095225). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.