Data / Medical devices / United States / Engineered Endodontics
Engineered Endodontics: FDA-registered device maker in Menomonee Falls, WI, United States, 6 510(k) clearances
Engineered Endodontics is registered with the FDA (registration 3012322979) in Menomonee Falls, WI, United States. It lists 10 device types. The FDA files 6 510(k) clearances under its listings, the newest dated May 23, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012322979
- Address
- W134N4965 Campbell Dr, Menomonee Falls, WI, United States, 53051
- Owner or operator
- Engineered Endodontics (10052002)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- May 31, 2016
- Registered through
- 2027
- Brand names listed
- ActaCal Paste, EndoScout Diamond Access bur, EndoScout Multi Use Bur, EndoScout Z style Bur, Filpin, Filpin Drill, Filpost, Finishing File and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bur, Dental | EJL | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| File, Pulp Canal, Endodontic | EKS | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Liner, Cavity, Calcium Hydroxide | EJK | 2 | Repackager or relabeler | accessdata.fda.gov |
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Post, Root Canal | ELR | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Preparer, Root Canal Endodontic | EKQ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 23, 2022 | K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid | KIF | Substantially Equivalent | Prevest Denpro Limited | accessdata.fda.gov |
| May 13, 2022 | K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) | EJK | Substantially Equivalent | Prevest Denpro Limited | accessdata.fda.gov |
| June 7, 2019 | K182145 | tün® ultrasonic tips product family | ELC | Substantially Equivalent | Engineered Endodontics | accessdata.fda.gov |
| April 25, 1990 | K901097 | FILLOCK REAMER | DZA | Substantially Equivalent | Ivoclar North America, Inc. | accessdata.fda.gov |
| March 5, 1990 | K896928 | FILPOST | ELR | Substantially Equivalent | Ivoclar North America, Inc. | accessdata.fda.gov |
| October 14, 1986 | K863831 | VIVADENT FILPIN | EBL | Substantially Equivalent | Vivadent (Usa), Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Drill, Dental, Intraoral
- All makers of Syringe, Periodontic, Endodontic, Irrigating
- All makers of Resin, Root Canal Filling
- All makers of Liner, Cavity, Calcium Hydroxide
- All makers of Post, Root Canal
- All makers of File, Pulp Canal, Endodontic
Updated May 23, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.