Manufacturer registered with FDA

Ranir, LLC

Allegan, MI, United States. Lists 13 dental device types with FDA across 2 registered establishments, and holds 2 510(k) clearances as applicant.

FDA owner/operator1825660Foreign exporterManufacturerRepacker / relabelerSpecification developer

Device types listed: 13
Brands and models: 14
510(k) clearances: 22010–2011
Markets registered in: 558 registrations outside the US
Establishments: 2China, United States

510(k) clearances per year, 2007–2026

Registered in 5 markets

Where regulators' registries name Ranir, LLC as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	Ranir, LLC	2 clearances	2010–2011	Below
Canada	Health Canada	Registration holder	RANIR LLC	42	2005–2023	Pure Global AI
Colombia	INVIMA	Manufacturer	RANIRRANIR LLC	14	—	Pure Global AI
Peru	DIGEMID	Manufacturer	RANIR LLC	1	2015–2015	Pure Global AI
South Korea	MFDS	Manufacturer	Ranir Changshu Oral Care Co. Ltd	1	2020–2020	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 Ranir, LLC currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Manual ToothbrushEFW · Class 1	Toothbrushes	Maker	—	1992
Intraoral Dental WaxEGD · Class 1	—	Maker	—	2011
Powered ToothbrushJEQ · Class 1	Toothbrushes	Maker	Advance CleanEasyFlexEssential Clean USBInfinityKidsPlackersPolarisPOWERED TOOTHBRUSHSmileSonicTotal Power 2 more 1G3G	1997
Dental FlossJES · Class 1	Floss & interdental cleaners	Maker	—	1992
Mouth MirrorEAX · Class 1	Dental hand instruments	Maker	—	2009
Heat Source for Bleaching TeethEEG · Class 1	Teeth whitening lights	Lister	—	2019
Oral Irrigation UnitEFS · Class 1	Oral irrigators	Lister	HydroClean	2021
Calculus Removal Hand InstrumentELA · Class 1	Dental hand instruments	Maker	—	2017
Periodontic ScalerEMN · Class 1	Dental hand instruments	Maker	—	2009
Massaging PickJET · Class 1	Floss & interdental cleaners	Maker	PLAK RX	1997
Tongue ScraperLCN · Class 1	—	Maker	—	2009
Anti-Snoring DeviceLRK · Class 2	Anti-snoring & jaw-repositioning devices	Maker	—	2010
Ultraviolet Sanitation/Sterilization (for Toothbrushes) Unit Non-SterileNOB · Class 1	—	Maker	—	2021

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Ranir, LLC as the applicant, including filings under its other names.

Decided	510(k)	Device	Device type
25 Feb 2011	K103004	SNORE GUARD	LRK Anti-Snoring Device
8 Sep 2010	K102118	SNORE GUARD ADVANCE	LRK Anti-Snoring Device

Registered establishments

Establishment	Location	What it does
Ranir Changshu Oral Care CO., LtdFDA reg. 3007336881	Changshu Jiangsu, China	Foreign exporter, Manufacturer, Repacker / relabeler
RANIR LLCFDA reg. 1825660	Grand Rapids, MI, United States	Complaint file establishment, Manufacturer, Repacker / relabeler, Specification developer

Other names on FDA records

Ranir Changshu Oral Care Co. Ltd

Sources

FDA establishment registration & device listing (search FDA, owner/operator 1825660). 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.