FDA.reportPublic FDA data

SUNSTAR AMERICAS, INC.

Matched from indexed company URL: SUNSTAR AMERICAS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
14137871413787SUNSTAR AMERICAS, INC.1Y2026-01-01301 East Central Road Schaumburg IL US 60195
14114851411485SUNSTAR AMERICAS INC.1N2020-04-251300 Abbott Drive Elgin IL US 60123

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00070942005425GUM® - Sonic Deep Clean Handle White+1(800)777-3101contact.us@us.sunstar.com
00070942005432GUM® - Sonic Deep Clean Handle Black+1(800)777-3101contact.us@us.sunstar.com
00070942008822GUM® Expanding Floss - GUM EXPANDING FLOSS WAXED 38.3 yds (35 m)+1(800)777-3101contact.us@us.sunstar.com
00070942008952GUM® Professional Clean Floss - Professional Clean String Floss, Mint Waxed, 38.3 YD+1(800)777-3101contact.us@us.sunstar.com
00070942783354GUM® - 36PC. MixedFlosser Wing+1(800)777-3101contact.us@us.sunstar.com
10070942003695GUM® CRAYOLA TWISTABLES FLOSSERS - CRAYOLA TWISTABLES FLOSSERS+1(800)777-3101contact.us@us.sunstar.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
505751362466668K974761BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSHEFW1998-06-16
505751419308918K952091VUTLER G.U.M. WITH FLUORIDEJES1995-06-28
505751277027206K950993BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSHEFW1995-06-02
505751048726929K946032FLUOR PROTECTORLBH1995-03-07
505752014096259K181134G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral SprayLFD2018-07-13
505751954747467K163448GrindCare SystemHCC2017-09-01
1004092003503041K132325GUIDOR BIORESORBABLE MATRIX BARRIERNPK2013-10-29
505751782542909K132109ENAMELASTLBH2013-11-01
505751959134954K131385EASY-GRAFTLYC2013-09-27
505751616370047K124025ALPHA-PRO WHITE VARNISHLBH2013-09-18
505751119787495K053166SINCLAIR ORAL RINSENTO2006-05-17
505751113491797K040950ALOCLAIR ORAL GELOLR2004-06-21
505751510061344K023155ALOCLAIR ORAL RINSEOLR2002-11-25
505751440800695
505751593658873
505751960096589
505751113076240
505751347650655
505751420140461
505751439736913
505751512656064
505751615567277
505751699985263
505751748641567
505751888344562
505752033421771

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LBH32013-11-01
OLR22004-06-21
EFW21998-06-16
LFD12018-07-13
HCC12017-09-01
NPK12013-10-29
LYC12013-09-27
NTO12006-05-17
JES11995-06-28

PMN#

Applications#

GUDID#

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