Manufacturer registered with FDA

Luv N' Care, Ltd.

Monroe, LA, United States. Lists 4 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator2381321Repacker / relabelerSpecification developer
Device types listed
4
Brands and models
5
510(k) clearances
12010–2010
Markets registered in
21 registrations outside the US
Establishments
1United States
2010: 120102020

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name Luv N' Care, Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 4 device types listedTaiwan: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerLuv N' Care, Ltd.1 clearances2010–2010Below
TaiwanTFDAManufacturerLUV N'CARE LTD.12010–2010Pure 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 Luv N' Care, Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Manual ToothbrushEFW · Class 1ToothbrushesLister
Toothbrush
2007
Powered ToothbrushJEQ · Class 1ToothbrushesLister—2017
Fluid-Filled Teething RingKKO · Class 2—Maker
Nuby Icy Bite Gel Teether
2010
Teething Ring Non-Fluid FilledMEF · Class 1—Maker
ChewbiesNuby SootherNuby Teether
1995

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 Luv N' Care, Ltd. as the applicant.

Decided510(k)DeviceDevice type
1 Mar 2010K092494GEL FILLED GUM SOOTHERKKO Fluid-Filled Teething Ring

Some of these clearances are listed with FDA today by another company: Ningbo Longwell Baby & Beauty Products Co Ltd (1), Elung Industrial Co.ltd. (1).

Registered establishments

EstablishmentLocationWhat it does
LUV N' CARE, LTD.FDA reg. 2381321Monroe, LA, United StatesComplaint file establishment, Repacker / relabeler, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 2381321). 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.