Registered with FDA
Dylan Lucas International Inc
Vaughan, Canada. Lists 12 dental device types with FDA across 1 registered establishment.
- Device types listed
- 12
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Canada
Devices listed with FDA
What Dylan Lucas International 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 |
|---|---|---|---|---|
| Impression MaterialELW · Class 2 | Impression materials | Lister | — | 2018 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | — | 2018 |
| Dental CementEMA · Class 2 | Dental cements | Lister | — | 2017 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Lister | — | 2026 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Lister | — | 2020 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | — | 2025 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Lister | — | 2017 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Lister | — | 2019 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Lister | — | 2022 |
| Preformed CrownELZ · Class 1 | — | Lister | — | 2017 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Lister | — | 2018 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | — | 2018 |
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
Dylan Lucas International 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: Sybron Dental Specialties (4), Espe Dental AG (2), Dentsply Intl., Inc. (2), Espe GmbH (Us) (2), 3M Espe Dental Products (1), GC America Inc. (1), Heraeus Kulzer, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 30 May 2013 | K130869 | TAKE 1 ADVANCE | Sybron Dental Specialties | ELW Impression Material |
| 5 May 2011 | K111185 | RELYX LUTING PLUS AUTOMIX | 3M Espe Dental Products | EMA Dental Cement |
| 20 Jan 2011 | K103351 | DMC COMPOSITE 2 | Sybron Dental Specialties | EBF Resin Tooth Shade Material |
| 17 Jul 2000 | K001730 | GC FUJICEM | GC America Inc. | EMA Dental Cement |
| 5 Apr 2000 | K000629 | FLEXTIME | Heraeus Kulzer, LLC | ELW Impression Material |
| 8 Sep 1999 | K992895 | IMPREGUM F | Espe Dental AG | ELW Impression Material |
| 8 Sep 1999 | K992897 | IMPREGUM PENTA | Espe Dental AG | ELW Impression Material |
| 8 Mar 1999 | K990498 | OPTIBOND SOLO PLUS | Sybron Dental Specialties | KLE Resin Tooth Bonding Agent |
| 11 Apr 1997 | K970123 | DENTSPLY CAVITRON SPS SCALER SYSTEM | Dentsply Intl., Inc. | ELC Ultrasonic Scaler |
| 17 Nov 1994 | K943642 | HERCULITE XR & XRV | Sybron Dental Specialties | EBF Resin Tooth Shade Material |
| 28 Mar 1990 | K900436 | PROTEMP II | Espe GmbH (Us) | EBG Resin Temporary Crown and Bridge |
| 19 Sep 1986 | K863092 | DENTAL COMPOSITE RESTORATIVE | Dentsply Intl., Inc. | EBF Resin Tooth Shade Material |
| 25 Mar 1985 | K844846 | ESPE KETAC-CEM RADIOPAQUE | Espe GmbH (Us) | EMA Dental Cement |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DYLAN LUCAS INTERNATIONAL INCFDA reg. 3011689956 | Vaughan Ontario, Canada | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10054202). 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.