Registered with FDA
Engineered Endodontics
Menomonee Falls, WI, United States. Lists 11 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 11
- Brands and models
- 13
- 510(k) clearances
- 12019–2019
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Engineered Endodontics 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 | Engineered Endodontics | 1 clearances | 2019–2019 | Below |
| Canada | Health Canada | Registration holder | ENGINEERED ENDODONTICS | 1 | 2026–2026 | 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 Engineered Endodontics currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Lister | Filpin Drill | 2024 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | Cialegese Mouth Mirrors | 2026 |
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Lister | Filpin | 2024 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Lister | Irrigator | 2021 |
| Calcium Hydroxide Cavity LinerEJK · Class 2 | — | Lister | ActaCal Paste | 2024 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | EndoScout Diamond Access burEndoScout Multi Use BurEndoScout Z style BurMunce Discovery BursMunce TruGrit | 2024 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Lister | — | 2023 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Lister | Finishing File | 2016 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Lister | tun ultrasonic tip | 2019 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Lister | Filpost | 2024 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Lister | — | 2024 |
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
Engineered Endodontics 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: Prevest Denpro Limited (2), Ivoclar North America, Inc. (2), Vivadent (Usa), Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 May 2022 | K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid | Prevest Denpro Limited | KIF Root Canal Filling Resin |
| 13 May 2022 | K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) | Prevest Denpro Limited | EJK Calcium Hydroxide Cavity Liner |
| 25 Apr 1990 | K901097 | FILLOCK REAMER | Ivoclar North America, Inc. | DZA Intraoral Dental Drill |
| 5 Mar 1990 | K896928 | FILPOST | Ivoclar North America, Inc. | ELR Root Canal Post |
| 14 Oct 1986 | K863831 | VIVADENT FILPIN | Vivadent (Usa), Inc. | EBL Retentive and Splinting Pin and Accessory Instruments |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ENGINEERED ENDODONTICSFDA reg. 3012322979 | Menomonee Falls, WI, United States | Complaint file establishment, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10052002). 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.