Data / Medical devices / United States / Swedent Dental Wholesale Group
Swedent Dental Wholesale Group: FDA-registered device maker in Provo, UT, United States, 3 510(k) clearances
Swedent Dental Wholesale Group is registered with the FDA (registration 3019381139) in Provo, UT, United States. It lists 9 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 12, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019381139
- Address
- 1675 N Freedom Blvd STE 9B2, Provo, UT, United States, 84604
- Owner or operator
- Swedent Dental Wholesale Group (10081704)
- Roles
- Repackager or relabeler
- First device listed
- May 10, 2021
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Eraser, Dental Stain | MAU | 1 | Repackager or relabeler | accessdata.fda.gov |
| Handpiece, Air-Powered, Dental | EFB | 1 | Repackager or relabeler | accessdata.fda.gov |
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Heat Source For Bleaching Teeth | EEG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 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 |
|---|---|---|---|---|---|---|
| March 12, 2021 | K192649 | Endo Motor | EKX | Substantially Equivalent | Foshan Cicada Dental Instrument Co, Ltd. | accessdata.fda.gov |
| February 13, 2020 | K192233 | LED Curing Light | EBZ | Substantially Equivalent | Foshan Cicada Dental Instrument Co, Ltd. | accessdata.fda.gov |
| December 9, 2019 | K181900 | Dental high speed handpiece, Dental low speed handpiece | EFB | Substantially Equivalent | Foshan Cicada Dental Instrument Co, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Container, Specimen, Non-Sterile
- All makers of Activator, Ultraviolet, For Polymerization
- All makers of Bur, Dental
- All makers of Handpiece, Direct Drive, Ac-Powered
- All makers of Handpiece, Air-Powered, Dental
- All makers of Heat Source For Bleaching Teeth
Updated March 12, 2021. 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.