Registered with FDA
Frontier Dental Supply Inc
Markham, Canada. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 23 registrations outside the US
- Establishments
- 1Canada
Registered in 2 markets
Where regulators' registries name Frontier Dental Supply Inc as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | Frontier Dental Supply Inc | 7 device types | — | Below |
| Canada | Health Canada | Registration holder | FRONTIER DENTAL SUPPLY INC. | 3 | 2023–2026 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Frontier Dental Supply 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 |
|---|---|---|---|---|
| Dental CementEMA · Class 2 | Dental cements | Lister | — | 2026 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | — | 2026 |
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Lister | — | 2026 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Lister | — | 2026 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | — | 2026 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | — | 2026 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | — | 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
Frontier Dental Supply 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), Espe GmbH (Us) (2), 3M Espe Dental Products (1), 3M Unitek Corporation (1), Kuraray Medical, Inc. (1), Espe GmbH & Co. Kg. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 5 May 2011 | K111185 | RELYX LUTING PLUS AUTOMIX | 3M Espe Dental Products | EMA Dental Cement |
| 12 May 2010 | K100235 | FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE | 3M Company | EBF Resin Tooth Shade Material |
| 15 Feb 2008 | K073697 | TRANSBOND SUPREME ADHESIVE | 3M Unitek Corporation | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 2 Aug 2002 | K022476 | RELYX RMGIP | 3M Company | EMA Dental Cement |
| 10 Sep 2001 | K012442 | MODIFICATION TO CLEARFIL SE BOND | Kuraray Medical, Inc. | KLE Resin Tooth Bonding Agent |
| 8 Oct 1999 | K992326 | 3M CLINPRO SEALANT | 3M Company | EBC Pit and Fissure Sealant and Conditioner |
| 17 Nov 1997 | K973262 | KETAC-FIL APLICAP PLUS | Espe GmbH & Co. Kg. | EMA Dental Cement |
| 18 Jul 1996 | K962065 | 3M VITREBOND LIGHT CURE GLASS IONOMER/BASE | 3M Company | EMA Dental Cement |
| 20 Mar 1992 | K920424 | SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM | 3M Company | KLE Resin Tooth Bonding Agent |
| 11 Aug 1988 | K882690 | IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL | 3M Company | ELW Impression Material |
| 1 Mar 1988 | K875133 | CAVIT-W | Espe GmbH (Us) | EBG Resin Temporary Crown and Bridge |
| 25 Mar 1985 | K844846 | ESPE KETAC-CEM RADIOPAQUE | Espe GmbH (Us) | EMA Dental Cement |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| FRONTIER DENTAL SUPPLY INCFDA reg. 3045891668 | Aurora Ontario, Canada | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10095856). 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.