Data / Medical devices / United States / Ismile Dental Products Inc.
Ismile Dental Products Inc.: FDA-registered device maker in Sacramento, CA, United States, 4 510(k) clearances
Ismile Dental Products Inc. is registered with the FDA (registration 3007046497) in Sacramento, CA, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 10, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007046497
- Address
- 4201 Sierra Point DR Ste 102, Sacramento, CA, United States, 95834
- Owner or operator
- iSmile Dental Products, Inc. (10052362)
- Roles
- Repackager or relabeler
- First device listed
- July 20, 2016
- Registered through
- 2026
- Brand names listed
- iSmile Dental Products
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dental Barriers And Sleeves | PEM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | 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 |
|---|---|---|---|---|---|---|
| September 10, 2019 | K190484 | BH Medical Dental Barrier Sleeves and Barrier Film | PEM | Substantially Equivalent | Bh Medical Products Co., Ltd. | accessdata.fda.gov |
| August 3, 2018 | K172280 | BH Sterilization Pouch | FRG | Substantially Equivalent | Bh Medical Products Co., Ltd. | accessdata.fda.gov |
| June 22, 2015 | K133070 | SURGICAL FACE MASK (Ear Loops and Tie-on) | FXX | Substantially Equivalent | Bh Medical Products Co., Ltd. | accessdata.fda.gov |
| January 13, 2011 | K102836 | BONASIL A+ IMPRESSION MATERIALS | ELW | Substantially Equivalent | Dmp, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Impression
- All makers of Mask, Surgical
- All makers of Wrap, Sterilization
- All makers of Dental Barriers And Sleeves
Updated September 10, 2019. 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.