Sunstar Americas Inc

FDA Filings

This page includes the latest FDA filings for Sunstar Americas Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Sunstar Americas Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number1411485
FEI Number1411485
NameSUNSTAR AMERICAS INC.
Owner & OperatorSunstar Americas, Inc.
Contact Address301 E Central Rd
Schaumburg IL 60195 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1300 Abbott Drive
Elgin, IL 60123 US
Establishment TypeManufacture Medical Device



Registration Number1413787
FEI Number1413787
NameSUNSTAR AMERICAS, INC.
Owner & OperatorSUNSTAR AMERICAS, INC.
Contact Address301 E Central Rd --
Schaumburg IL 60195 US
Official Correspondent
  • GREGORY W BELAIR
  • 001-847-7944241-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address301 East Central Road
Schaumburg, IL 60195 US
Establishment Type
  • Repack or Relabel Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
SUNSTAR AMERICAS, INC.
GUM® 2024-11-07
SUNSTAR AMERICAS, INC.
GUM 2024-10-14
SUNSTAR AMERICAS, INC.
GUM 2024-10-14
SUNSTAR AMERICAS, INC.
GUM 2024-10-14
SUNSTAR AMERICAS, INC.
GUM R2024-05-07
SUNSTAR AMERICAS, INC.
GUM RA2024-05-07
SUNSTAR AMERICAS, INC.
GUM® ECM42024-04-15
SUNSTAR AMERICAS, INC.
GUM® ECM62024-04-15
SUNSTAR AMERICAS, INC.
GUM® R15ECM42024-04-15
SUNSTAR AMERICAS, INC.
GUM P2024-04-03
SUNSTAR AMERICAS, INC.
GUM Crayola Power Toothbrush 2024-04-02
SUNSTAR AMERICAS, INC.
GUM Mixed Mini Wing 2024-04-02
SUNSTAR AMERICAS, INC.
GUM Barbie Power Toothbrush 2024-04-02
SUNSTAR AMERICAS, INC.
GUM Dual Technique 2024-04-02
SUNSTAR AMERICAS, INC.
GUM® P2024-03-25
SUNSTAR AMERICAS, INC.
GUM® P2024-03-22
SUNSTAR AMERICAS, INC.
GUM® P2024-03-21
SUNSTAR AMERICAS, INC.
GUM® R2024-03-20
SUNSTAR AMERICAS, INC.
GUM® RA2024-03-20
SUNSTAR AMERICAS, INC.
GUM® RA2024-03-20
SUNSTAR AMERICAS, INC.
GUM® R2024-03-20
SUNSTAR AMERICAS, INC.
GUM® P2024-03-20
SUNSTAR AMERICAS, INC.
GUM® R2024-03-20
SUNSTAR AMERICAS, INC.
GUM® P2024-03-19
SUNSTAR AMERICAS, INC.
GUM® P2024-03-18
SUNSTAR AMERICAS, INC.
GUM® P2024-03-18
SUNSTAR AMERICAS, INC.
GUM® P2024-03-18
SUNSTAR AMERICAS, INC.
GUM® P2024-03-15
SUNSTAR AMERICAS, INC.
GUM® P2024-03-13
SUNSTAR AMERICAS, INC.
GUM® ECM62024-02-12
SUNSTAR AMERICAS, INC.
GUM® PQB2023-12-15
SUNSTAR AMERICAS, INC.
GUM® PQA2023-12-15
SUNSTAR AMERICAS, INC.
GUM® ECM62023-10-20
SUNSTAR AMERICAS, INC.
GUM® ECM62023-10-20
SUNSTAR AMERICAS, INC.
GUM® ECM62023-10-20
SUNSTAR AMERICAS, INC.
GUM® RQ82023-09-13
SUNSTAR AMERICAS, INC.
GUM® ECMW2023-08-31
SUNSTAR AMERICAS, INC.
GUM® ECMB2023-08-31
SUNSTAR AMERICAS, INC.
GUM® ECMW2023-08-31
SUNSTAR AMERICAS, INC.
GUM® ECMB2023-08-31
SUNSTAR AMERICAS, INC.
GUM® R9ECM32023-08-31
SUNSTAR AMERICAS, INC.
GUM® R15ECM32023-08-31
SUNSTAR AMERICAS, INC.
GUM® PQ2023-08-31
SUNSTAR AMERICAS, INC.
GUM® RQ92023-08-31
SUNSTAR AMERICAS, INC.
GUM® RQ152023-08-31
SUNSTAR AMERICAS, INC.
GUM® UTB2023-06-22
SUNSTAR AMERICAS, INC.
GUM® UTW2023-06-22
SUNSTAR AMERICAS, INC.
GUM® URW2023-06-22
SUNSTAR AMERICAS, INC.
GUM® URB2023-06-22
SUNSTAR AMERICAS, INC.
GUM® PQ2023-06-19
SUNSTAR AMERICAS, INC.
GUM® 8712023-06-02
SUNSTAR AMERICAS, INC.
GUM® 36142023-06-02
SUNSTAR AMERICAS, INC.
GUM® 8722023-06-02
SUNSTAR AMERICAS, INC.
GUM® 36122023-06-02
SUNSTAR AMERICAS, INC.
GUM® 22032023-03-08
SUNSTAR AMERICAS, INC.
GUM® 22022023-03-08
SUNSTAR AMERICAS, INC.
GUM® PDQ2023-02-13
SUNSTAR AMERICAS, INC.
GUM® RQ; RQW2022-11-29
SUNSTAR AMERICAS, INC.
GUM® RQ42022-11-28
SUNSTAR AMERICAS, INC.
GUM® RQ42022-11-28
SUNSTAR AMERICAS, INC.
GUM® RQ152022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQ152022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQ152022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQ152022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQ62022-11-18
SUNSTAR AMERICAS, INC.
GUM® PQ2022-11-18
SUNSTAR AMERICAS, INC.
GUM® PQ2022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQA2022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQF2022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQF2022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQF2022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQ2022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQT2022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQT2022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQ2022-11-18
SUNSTAR AMERICAS, INC.
GUM® PQ2022-11-18
SUNSTAR AMERICAS, INC.
GUM® PQ2022-11-18
SUNSTAR AMERICAS, INC.
GUM® PQ2022-11-18
SUNSTAR AMERICAS, INC.
GUM® PQ2022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQ42022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQ2022-11-18
SUNSTAR AMERICAS, INC.
GUM® PQ2022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQ62022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQB; RQ752022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQ2022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQ2022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQ2022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQT2022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQ; RQW2022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQ; RQW; RQ42022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQ; RQW; RQ42022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQ; RQW; RQ42022-11-18
SUNSTAR AMERICAS, INC.
GUM® PQ2022-11-18
SUNSTAR AMERICAS, INC.
GUM® PQ2022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQ42022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQ152022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQ152022-11-18
SUNSTAR AMERICAS, INC.
GUM® RQT2022-11-18
SUNSTAR AMERICAS, INC.
GUM® PQA2022-11-18
SUNSTAR AMERICAS, INC.
GUM® PQA2022-11-18
Sunstar Americas, Inc.
Prescription Medication2021-10-20
Sunstar Americas, Inc.
Otc Medication2021-01-31
Sunstar Americas, Inc.
Barbie Anticavity Fluoride2021-01-22
Sunstar Americas, Inc.
Otc Medication2021-01-09
Sunstar Americas, Inc.
Otc Medication2021-01-09
Sunstar Americas, Inc.
Otc Medication2021-01-09
Sunstar Americas, Inc.
Otc Medication2021-01-09
Sunstar Americas, Inc.
Otc Medication2021-01-09
Sunstar Americas, Inc.
Otc Medication2021-01-09
Sunstar Americas, Inc.
Otc Medication2019-12-17
Sunstar Americas, Inc.
Otc Medication2019-11-26
Sunstar Americas, Inc.
SUNSTAR G.U.M HYDRAL DRY MOUTH RELIEF2019-11-19
Sunstar Americas, Inc.
Otc Medication2019-11-18
Sunstar Americas, Inc.
Otc Medication2018-11-03
SUNSTAR AMERICAS, INC.
GUM HYDRAL (Gel, Rinse, Spray)2018-07-16
SUNSTAR AMERICAS, INC.
GrindCare System2018-07-16
SUNSTAR AMERICAS, INC.
GrindCare System2018-07-16
SUNSTAR AMERICAS, INC.
GrindCare System2018-07-16
Sunstar Americas Inc
G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray2018-07-13
Sunstar Americas, Inc.
Otc Medication2018-07-06
Sunstar Americas, Inc.
Otc Medication2018-07-06
Sunstar Americas, Inc.
Prescription Medication2018-05-08
Sunstar Americas, Inc.
Crayola Anticavity Fluoride FRUIT EXPLOSION2018-04-02
Sunstar Americas, Inc.
GUM Cavity Prevention Fluoride Mint2018-04-01
Sunstar Americas, Inc.
GUM Crayola Anticavity Fluoride Tropical Twist2018-04-01
SUNSTAR AMERICAS, INC.
BUTLER, MONSTERZ2017-12-13
SUNSTAR AMERICAS, INC.
BUTLER2017-12-13
Sunstar Americas, Inc
Otc Medication2016-04-13
Sunstar Americas, Inc
Equitance Sunscreen Broad Spectrum SPF 362016-04-12
Sunstar Americas, Inc.
Crayola2015-11-30
Sunstar Americas, Inc.
Power-Rangers2015-11-30
Sunstar Americas, Inc.
Otc Medication2015-11-30
SUNSTAR AMERICAS, INC.
BUTLER PROTECT Fluoride Trays2015-07-22
SUNSTAR AMERICAS, INC.
RINCINOL P.R.N. Oral Rinse2015-05-05
Sunstar Americas, Inc.
Otc Medication2014-11-21
SUNSTAR AMERICAS, INC.
PerioShield Oral Rinse2014-10-27
SUNSTAR AMERICAS INC. [Sunstar Americas, Inc.]
GUIDOR? Bioresorbable Matrix Barrier2014-09-03
SUNSTAR AMERICAS, INC.
MONSTERZ Fluoride Varnish2013-12-24
SUNSTAR AMERICAS, INC.
BUTLER Fluoride Varnish2013-12-24
SUNSTAR AMERICAS, INC.
GUIDOR Easy-Graft Classic2013-12-24
Sunstar Americas, Inc.
Gum2013-12-01
Sunstar Americas, Inc.
Otc Medication2013-12-01
SUNSTAR AMERICAS, INC.
GUIDOR BIORESORBABLE MATRIX BARRIER2013-10-29
Sunstar Americas, Inc.
Crayola2013-07-03
SUNSTAR AMERICAS, INC.
RED-COTE2012-11-29
SUNSTAR AMERICAS, INC.
BUTLER2011-12-30
SUNSTAR AMERICAS, INC.
BUTLER MONSTERZ2011-12-30
SUNSTAR AMERICAS, INC.
BUTLER CALCI-FLOR PROPHYLAXIS PASTE2011-02-03
SUNSTAR AMERICAS, INC.
CANKER-X Oral Gel2009-12-28
SUNSTAR AMERICAS, INC.
PROPHYCIENCY2008-01-16
SUNSTAR AMERICAS, INC.
MONSTERZ2008-01-16
SUNSTAR AMERICAS, INC.
EEZ-TOUCH2008-01-16
SUNSTAR AMERICAS, INC.
DUROPRO2008-01-16
SUNSTAR AMERICAS, INC.
BUTLER2008-01-16
SUNSTAR AMERICAS, INC.
BUTLER PASTE-FREE2008-01-16
SUNSTAR AMERICAS, INC.
BUTLER BLOOM2008-01-16
Sunstar Americas, Inc.
PAROEX2006-04-15
SUNSTAR AMERICAS, INC.
G-U-M Tongue Scraper2002-04-01
SUNSTAR AMERICAS, INC.
STAR WARS2001-04-06
SUNSTAR AMERICAS, INC.
SESAME STREET2001-04-06
SUNSTAR AMERICAS, INC.
ROTAPOWER2001-04-06
SUNSTAR AMERICAS, INC.
PULSE2001-04-06
SUNSTAR AMERICAS, INC.
POWER RANGERS2001-04-06
SUNSTAR AMERICAS, INC.
G-U-M2001-04-06
SUNSTAR AMERICAS, INC.
CRAYOLA2001-04-06
SUNSTAR AMERICAS, INC.
SOFT-PICKS1992-06-25
SUNSTAR AMERICAS, INC.
G-U-M Gum Stimulator1992-06-25
SUNSTAR AMERICAS, INC.
G-U-M Gum Stimulator Refills1992-06-25
SUNSTAR AMERICAS, INC.
Lion Guard1992-06-25
SUNSTAR AMERICAS, INC.
G-U-M Floss1992-06-25
SUNSTAR AMERICAS, INC.
G-U-M Floss Threaders1992-06-25
SUNSTAR AMERICAS, INC.
FLOSSMATE Handle1992-06-25
SUNSTAR AMERICAS, INC.
FLOSBRUSH1992-06-25
SUNSTAR AMERICAS, INC.
Elena1992-06-25
SUNSTAR AMERICAS, INC.
Eez-Thru1992-06-25
SUNSTAR AMERICAS, INC.
EXPANDING1992-06-25
SUNSTAR AMERICAS, INC.
EASYTHREAD1992-06-25
SUNSTAR AMERICAS, INC.
DOLPHIN Flosser1992-06-25
SUNSTAR AMERICAS, INC.
CRAYOLA1992-06-25
SUNSTAR AMERICAS, INC.
BUTLERWEAVE1992-06-25
SUNSTAR AMERICAS, INC.
BUTLER Floss1992-06-25
SUNSTAR AMERICAS, INC.
G-U-M Orthodontic Wax1992-06-25
SUNSTAR AMERICAS, INC.
TRAV-LERS1992-06-25
SUNSTAR AMERICAS, INC.
TECHNIQUE1992-06-25
SUNSTAR AMERICAS, INC.
Soy Luna1992-06-25
SUNSTAR AMERICAS, INC.
Sea Friends1992-06-25
SUNSTAR AMERICAS, INC.
SUPER TIP1992-06-25
SUNSTAR AMERICAS, INC.
SUMMIT1992-06-25
SUNSTAR AMERICAS, INC.
STAR WARS1992-06-25
SUNSTAR AMERICAS, INC.
SNAP-ONS1992-06-25
SUNSTAR AMERICAS, INC.
Razzle Dazzle1992-06-25
SUNSTAR AMERICAS, INC.
PROXABRUSH1992-06-25
SUNSTAR AMERICAS, INC.
POWER RANGERS1992-06-25
SUNSTAR AMERICAS, INC.
MICRO TIP1992-06-25
SUNSTAR AMERICAS, INC.
MAXMASSAGE1992-06-25
SUNSTAR AMERICAS, INC.
Lion Guard1992-06-25
SUNSTAR AMERICAS, INC.
Li-l Safari Friends1992-06-25
SUNSTAR AMERICAS, INC.
LALALOOPSY1992-06-25
SUNSTAR AMERICAS, INC.
How to Train Your Dragons1992-06-25
SUNSTAR AMERICAS, INC.
GO-BETWEENS1992-06-25
SUNSTAR AMERICAS, INC.
G-U-M1992-06-25
SUNSTAR AMERICAS, INC.
Elena1992-06-25
SUNSTAR AMERICAS, INC.
Dome Trim1992-06-25
SUNSTAR AMERICAS, INC.
DINOSAUR TRAIN1992-06-25
SUNSTAR AMERICAS, INC.
CRAYOLA1992-06-25
SUNSTAR AMERICAS, INC.
G-U-M Lighted Mirror1992-06-25

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    U.S. Import Records [external site]
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    2020092933290Shanghai ,China (Mainland) -> Long Beach, CaliforniaFLOSSER INTERDENTAL BRUSH4721 CTN
    2020092933290Shanghai ,China (Mainland) -> Long Beach, CaliforniaFLOSSER INTERDENTAL BRUSH4721 CTN
    2020092933290Shanghai ,China (Mainland) -> Long Beach, CaliforniaFLOSSER INTERDENTAL BRUSH4721 CTN
    2020092846216Hong Kong,Hong Kong -> Long Beach, CaliforniaDENTAL PRODUCTS (DAP AND LIGHTED MIRROR)145 CTN
    2020092855827Shanghai ,China (Mainland) -> Los Angeles, CaliforniaFLOSSER STIMULATOR2300 CTN
    2020092859731Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseyPALLETS SOFT PICK DENTAL EQUIPMENT HS CODE42 PKG
    2020092859731Rotterdam,Netherlands -> New York/Newark Area, Newark, New JerseyPALLETS SOFT PICK DENTAL EQUIPMENT42 PKG
    2020092515687Xingang,China (Mainland) -> Los Angeles, CaliforniaTOOTH BRUSHES TOOTHBRUSH FLOSS NO WOOD PACKING MATERIAL IS USED IN THIS SHIPMENT CARMEN.KEADY US.SUNSTAR.COM1453 CTN
    2020092516989Hong Kong,Hong Kong -> Long Beach, CaliforniaDENTAL PRODUCTS (LIGHTED MIRROR)49 CTN
    2020092442825Yantian,China (Mainland) -> Tacoma, WashingtonDENTAL FLOSS YARN USED TO CLEAN BETWEEN TEET CONTAINER NO.YMLU8895020 SEAL NO.YMAH042519 DENTAL FLOSS 1291CTNS G.W 9447KGS 51.08CBM H.S CODE 3306200000 WAX BLOCKS 375CTNS G.W 996KGS2140 PKG
    2020092442825Yantian,China (Mainland) -> Tacoma, WashingtonDENTAL FLOSS YARN USED TO CLEAN BETWEEN TEET CONTAINER NO.YMLU8895020 SEAL NO.YMAH042519 DENTAL FLOSS 1291CTNS G.W 9447KGS 51.08CBM H.S CODE 3306200000 WAX BLOCKS 375CTNS G.W 996KGS2140 PKG
    2020092252207Hong Kong,Hong Kong -> Long Beach, CaliforniaDENTAL PRODUCTS (LIGHTED MIRROR)49 CTN

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