Manufacturer registered with FDA
Scanderra GmbH
Basel, Switzerland. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 77
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Switzerland
Devices listed with FDA
What Scanderra GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | EW-WJ180 Flosserpik Power SpaEW-WJ900 Flosserpik Lighthouse Oral IrrigatorEW-WJ950 Flosserpik Pro Station Oral IrrigatorEW-WJR2 Flosserpik WJ180 replacement tips setEW-WJR5 Flosserpik Pro Station Replacement SetEW-WJR9 Flosserpik WJ900 replacement tips set | 2021 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | EW-CC CleanCurl Curved toothbrush in blisterEW-GUMP Pro Gums ToothbrushEW-GUMP24 Pro Gums Toothbrush BULK, 24 pcs in inner boxEW-ID7-A Interdental Brush assorted 6pcs in PP boxEW-ID7-L Interdental Brush 0.8mm 6pcs in PP boxEW-ID7-M Interdental Brush 0.7mm 6pcs in PP boxEW-ID7-S Interdental Brush 0.6mm 6pcs in PP boxEW-ID7-SS Interdental Brush 0.5mm 6pcs in PP boxEW-ID7-SSS Interdental Brush 0.45mm 6pcs in PP boxEW-ID7-XS Interdental Brush 0.42mm 6pcs in PP box 26 moreEW-ID7.25 L 0.8mm in bag BULKEW-ID7.25 M 0.7mm in bag BULKEW-ID7.25 S 0.6mm in bag BULKEW-ID7.25 SS 0.5mm in bag BULKEW-ID7.25 SSS 0.45mm in bag BULKEW-ID7.25 XS 0.4mm in bag BULKEW-ID7.40 Interdental Brush assorted SampleCube boxEW-K3D Kids Flosserbrush Ultrasoft in blisterEW-ORTHO Pro Ortho ToothbrushEW-ORTHO24 Pro Ortho Toothbrush BULK, 24 pcs in inner boxEW-ST2 Single Tuft Brush Travel size in blisterEW-TD Flosserbrush TO GO Soft in blisterEW-TW Whitening TO GO pocket toothbrushEW-VD Flosserbrush Soft in blisterEW-VD Soft Intensive Flosserbrush SWISS in PET boxEW-VD24 Flosserbrush Soft SWISS with cap BULKEW-VSD Ultrasoft Flosserbrush SWISS in PET boxEW-VSD2 Duo Flosserbrush Ultrasoft, SWISS logo, 2 caps, PET boxEW-VSD24 Flosserbrush Ultrasoft SWISS with cap BULKEW-VSDB Flosserbrush Ultrasoft in blisterEW-VSDF Flosserbrush Ultrasoft in foilEW-VW Eraser Whitening toothbrush in PET boxMS-BW Black Whitening M in silver bagMS-BW SOFT toothbrush in Duo PET boxMS-BW toothbrush in Duo PET boxMS-LOOP toothbrush in Duo PET box | 2019 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | EW-EF25 Expanding Superfloss 25m in blisterEW-EF25 Expanding Superfloss 25m in blister, without Exp DateEW-PC70 Easy Tape Waxed Dental Tape Caipirinha in blisterEW-PCR250 Easy Tape Waxed Dental Tape Caipirinha Refill 250mEW-PL250 Easy Tape Waxed Dental Tape orange 250mEW-PL5 Easy Tape orange 5m in cello, 25 pcs in bagEW-PL5 Easy Tape Waxed Dental Tape orange 5m in celloEW-PL70 Easy Tape Waxed Dental Tape orange in blisterEW-PLR250 Easy Tape Waxed Dental Tape orange Refill 250mEW-WF40 Soft Woven Floss 40m in blister, with cinnamon 2 moreEW-XF50 Supersoft Floss 50 strandsEW-XF50 Supersoft Floss 50 strands, without Exp Date | 2019 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | EW-SG28 Brush Heads ultrasoft for SG8 WinnerEW-SG2A Dual Clean Ultrasoft Airbag Brush HeadsEW-SG2B Bacterio Target & Focus Brush headsEW-SG2C Clean Curl Airbag Sonic Brush HeadsEW-SG2F Focus Brush Head Duo for SG8+EW-SG2W Whitening Brush Heads for Sonic Generation SG8+EW-SG8 Sonic Generation 8 Winner UltrasoftEW-SG8+ Sonic Generation Health SuiteEW-SG8T Sonic Generation 8 Pro-Tester UltrasoftEW-SG9 Sonic Viva Toothbrush Ascona Rose 10 moreEW-SG9 Sonic Viva Toothbrush Davos YellowEW-SG9 Sonic Viva Toothbrush Zurich BlueMS-BWII2 Sonic Black Whitening II brush heads electric yellowMS-BWII2 Sonic Black Whitening II brush heads ink blackMS-BWII2 Sonic Black Whitening II brush heads pacific blueMS-BWII2 Sonic Black Whitening II brush heads shocking pinkMS-SONIC2 Sonic Black Whitening II electric yellowMS-SONIC2 Sonic Black Whitening II ink blackMS-SONIC2 Sonic Black Whitening II pacific blueMS-SONIC2 Sonic Black Whitening II shocking pink | 2019 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Lister | EW-PSM50 Pick Sticks Medium 50 pcsEW-PSS50 Pick Sticks Small 50 pcs | 2019 |
| Tongue ScraperLCN · Class 1 | — | Maker | EW-TC4, Large Size Tongue Cleaner 3 pcs in blister | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SCANDERRA LLB AGFDA reg. 3009488700 | Basel Basel-Stadt, Switzerland | Repacker / relabeler, Specification developer |
Other names on FDA records
Scanderra LLB AG
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10060196). 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.