Data / Medical devices / United States / Ranir LLC
Ranir LLC: FDA-registered device maker in Grand Rapids, MI, United States, 3 510(k) clearances
Ranir LLC is registered with the FDA (registration 1825660) in Grand Rapids, MI, United States. It lists 14 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 20, 2013. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1825660
- Address
- 4701 E Paris Ave Se, Grand Rapids, MI, United States, 49512
- Owner or operator
- RANIR LLC (1825660)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- July 2, 1992
- Registered through
- 2026
- Brand names listed
- 1G, 3G, Advance Clean, EasyFlex, Essential Clean USB, Grind-No-More, HydroClean, Infinity and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Heat Source For Bleaching Teeth | EEG | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Hand, Calculus Removal | ELA | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Mouthguard, Over-The-Counter | OBR | U | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Scaler, Periodontic | EMN | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Scraper, Tongue | LCN | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Unit, Oral Irrigation | EFS | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile | NOB | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| December 20, 2013 | K133423 | REST ASSURED EXTRA COMFORT NITE PROTECTOR | OBR | Substantially Equivalent | Ranir, LLC | accessdata.fda.gov |
| September 8, 2010 | K102118 | SNORE GUARD ADVANCE | LRK | Substantially Equivalent | Ranir, LLC | accessdata.fda.gov |
| May 8, 2009 | K091175 | GRIND NO MORE VERSION 2 AND 3 | OBR | Substantially Equivalent | Ranir, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 18, 2013 | 67123 | Class II | Terminated | TopCare Clifford THE BIG RED DOG power toothbrush for kids! | Ranir, LLC is recalling all lots of Up & Up brand Kid's Power Toothbrush and TopCare brand Clifford Kids Power Toothbrush because the tufted disk may become detached from the power brush handle. If the tuft retention disk detaches from the handle, it is a potential choking hazard for children three years old and younger. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Hand, Calculus Removal
- All makers of Mouthguard, Over-The-Counter
- All makers of Unit, Oral Irrigation
- All makers of Pick, Massaging
- All makers of Scraper, Tongue
- All makers of Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile
Updated January 17, 2014. 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.