Registered with FDA
Zapalign Inc.
Seongnam-si,, South Korea. Lists 11 dental device types with FDA across 1 registered establishment.
- Device types listed
- 11
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1South Korea
Devices listed with FDA
What Zapalign Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | Material, tooth shade, resin | 2026 |
| Dental CementEMA · Class 2 | Dental cements | Lister | CEMENT, DENTALPROVI CEMENT | 2025 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | MATERIAL, IMPRESSION | 2026 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | AGENT, TOOTH BONDING, RESIN | 2026 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Lister | Material, tooth shade, resin | 2026 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | CROWN AND BRIDGE, TEMPORARY, RESIN | 2026 |
| X-Ray Film HolderEGZ · Class 1 | — | Lister | — | 2026 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | — | 2026 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Lister | Cavitron | 2025 |
| Preformed CrownELZ · Class 1 | — | Lister | CROWN, PREFORMED | 2026 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Lister | ZINC OXIDE EUGENOL | 2026 |
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 Inc. 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 (6), 3M Espe Dental Products (3), Espe GmbH (Us) (2), 3M Company Espe Dental Products (1), 3M Deutschland GmbH (1), Dentsply Sirona, Inc. (1), 3M Espe AG Dental Products (1), S & C Polymer GmbH (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 13 Jun 2022 | K221695 | 3M Filtek Supreme Flowable Restorative | 3M Company Espe Dental Products | EBF Resin Tooth Shade Material |
| 31 Oct 2019 | K192961 | ADH19 | 3M Deutschland GmbH | KLE Resin Tooth Bonding Agent |
| 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 |
| 27 Sep 2016 | K160825 | MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology | Dentsply Sirona, Inc. | EKX Ac-Powered Direct Drive Handpiece |
| 19 Mar 2012 | K120453 | FILTEK BULK FILL FLOWABLE RESTORATIVE | 3M Espe Dental Products | EBF Resin Tooth Shade Material |
| 12 May 2010 | K100235 | FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE | 3M Company | EBF Resin Tooth Shade Material |
| 25 Oct 2006 | K062292 | UNICEM | 3M Espe Dental Products | EMA Dental Cement |
| 11 Aug 2003 | K032001 | POLY Q (GARANT L, PENTA M, PENTA H) | 3M Espe AG Dental Products | ELW Impression Material |
| 28 Sep 2000 | K002452 | 3M RELY X VENEER CEMENT TRY-IN PASTER | 3M Company | EMA Dental Cement |
| 5 Jun 1998 | K973201 | PROVI CEMENT | S & C Polymer GmbH | EMA Dental Cement |
| 11 Apr 1997 | K970123 | DENTSPLY CAVITRON SPS SCALER SYSTEM | Dentsply Intl., Inc. | ELC Ultrasonic Scaler |
| 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 |
| 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 INC.FDA reg. 3011944170 | Anyang-si Gyeonggi, South Korea | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10091758). 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.