us.sunstar.com
xx.xxPAROEX
chlorhexidine gluconate
SUNSTAR AMERICAS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1413787 | 1413787 | SUNSTAR AMERICAS, INC. | 1 | Y | 2027-01-01 | 301 East Central Road Schaumburg IL US 60195 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00070942007160 | GUM® - ADVANCED CARE FLOSSER PICKS FRESH MINT, Professional samples | +1(800)777-3101 | contact.us@us.sunstar.com |
| 07640164360072 | GUIDOR - easy-graft CLASSIC Bone grafting material, synthetic | 8002658353 | xx@xx.xx |
| 07640164360089 | GUIDOR - easy-graft CLASSIC Bone grafting material, synthetic | 8002658353 | xx@xx.xx |
| 07640164360096 | GUIDOR - easy-graft CLASSIC Bone grafting material, synthetic | 8002658353 | xx@xx.xx |
| 07640164360140 | GUIDOR - easy-graft CLASSIC Bone grafting material, synthetic | 8002658353 | xx@xx.xx |
| 10070942003695 | GUM® CRAYOLA TWISTABLES FLOSSERS - CRAYOLA TWISTABLES FLOSSERS | +1(800)777-3101 | contact.us@us.sunstar.com |
| 10070942751572 | GUM® - COMFORT SLIDE DENTAL FLOSS MINT 4 YD | +1(800)777-3101 | contact.us@us.sunstar.com |
| 10070942751619 | GUM® - BUTLERWEAVE WAXED | +1(800)777-3101 | contact.us@us.sunstar.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 50575 | 1362466668 | K974761 | BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH | EFW | 1998-06-16 |
| 50575 | 1419308918 | K952091 | VUTLER G.U.M. WITH FLUORIDE | JES | 1995-06-28 |
| 50575 | 1277027206 | K950993 | BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH | EFW | 1995-06-02 |
| 50575 | 1048726929 | K946032 | FLUOR PROTECTOR | LBH | 1995-03-07 |
| 50575 | 2014096259 | K181134 | G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray | LFD | 2018-07-13 |
| 50575 | 1954747467 | K163448 | GrindCare System | HCC | 2017-09-01 |
| 50575 | 1782542909 | K132109 | ENAMELAST | LBH | 2013-11-01 |
| 50575 | 1959134954 | K131385 | EASY-GRAFT | LYC | 2013-09-27 |
| 50575 | 1616370047 | K124025 | ALPHA-PRO WHITE VARNISH | LBH | 2013-09-18 |
| 50575 | 1119787495 | K053166 | SINCLAIR ORAL RINSE | NTO | 2006-05-17 |
| 50575 | 1113491797 | K040950 | ALOCLAIR ORAL GEL | OLR | 2004-06-21 |
| 50575 | 1510061344 | K023155 | ALOCLAIR ORAL RINSE | OLR | 2002-11-25 |
| 50575 | 1440800695 | ||||
| 50575 | 1593658873 | ||||
| 50575 | 1960096589 | ||||
| 50575 | 1113076240 | ||||
| 50575 | 1347650655 | ||||
| 50575 | 1420140461 | ||||
| 50575 | 1439736913 | ||||
| 50575 | 1512656064 | ||||
| 50575 | 1615567277 | ||||
| 50575 | 1699985263 | ||||
| 50575 | 1748641567 | ||||
| 50575 | 1888344562 | ||||
| 50575 | 2033421771 |
Product Codes Associated With Registrations#
NDC#
PAROEX
chlorhexidine gluconate
Crayola
Sodium Fluoride
Crayola
Sodium Fluoride
Crayola
Sodium Fluoride
Gum
Sodium Fluoride
Power-Rangers
Sodium Fluoride
Crayola
Sodium Fluoride
Crayola
Sodium Fluoride
SUNSTAR G.U.M HYDRAL DRY MOUTH RELIEF
Sodium fluoride
SUNSTAR G.U.M HYDRAL DRY MOUTH RELIEF
Sodium fluoride
GUM Crayola Anticavity Fluoride Tropical Twist
Sodium Fluoride
GUM Crayola Anticavity Fluoride Tropical Twist
Sodium Fluoride
Barbie Anticavity Fluoride
Sodium Fluoride
Crayola Anticavity Fluoride FRUIT EXPLOSION
Sodium Fluoride
Crayola Anticavity Fluoride FRUIT EXPLOSION
Sodium Fluoride
GUM Cavity Prevention Fluoride Mint
Sodium Fluoride
GUM Cavity Prevention Fluoride Mint
Sodium Fluoride
PMN#
GUIDOR BIORESORBABLE MATRIX BARRIER
SUNSTAR AMERICAS, INC.
BUTLER CALCI-FLOR PROPHYLAXIS PASTE
SUNSTAR AMERICAS, INC.
GUDID#
GUM® - ADVANCED CARE FLOSSER PICKS FRESH MINT, Professional samples
2026-10-08
GUIDOR - easy-graft CLASSIC Bone grafting material, synthetic
2015-10-22
GUIDOR - easy-graft CLASSIC Bone grafting material, synthetic
2015-10-22
GUIDOR - easy-graft CLASSIC Bone grafting material, synthetic
2015-10-22
GUIDOR - easy-graft CLASSIC Bone grafting material, synthetic
2015-10-22
GUM® CRAYOLA TWISTABLES FLOSSERS - CRAYOLA TWISTABLES FLOSSERS
2025-11-04
GUM® - COMFORT SLIDE DENTAL FLOSS MINT 4 YD
2022-11-10
GUM® - BUTLERWEAVE WAXED
2022-11-10
GUM® - EASYTHREAD FLOSS
2022-11-10
GUM® - BUTLERWEAVE DENTAL FLOSS SPECIAL WEAVE 24YD
2022-11-10
GUM® - CRAYOLA KIDS' FLOSSERS GRAPE FLAVOR
2022-11-10
GUM® - GUM Squishmallows KIDS FLOSSERS
2026-07-28
GUM® - PROXABRUSH GO-BETWEENS CLEANERS VARIETY PACK
2023-01-26
GUM® - PROXABRUSH GO-BETWEENS CLEANERS VARIETY PACK
2023-12-07
GUM® - Sonic Deep Clean Handle White
2023-06-14
GUM® - Sonic Deep Clean Handle Black
2023-06-14
GUM® Expanding Floss - GUM EXPANDING FLOSS WAXED 38.3 yds (35 m)
2026-05-01
GUM® Professional Clean Floss - Professional Clean String Floss, Mint Waxed, 38.3 YD
2026-04-30
GUM® - 36PC. MixedFlosser Wing
2024-03-12
GUM Technique Sensitive Clean - GUM Technique Sensitive Clean is a Manual Toothbrush with Antibacterial Bristles
2025-08-15
GUM Technique Sensitive Clean - GUM Technique Sensitive Clean is a Manual Toothbrush with Antibacterial Bristles
2025-08-15
GUM Technique Sensitive Clean - GUM Technique Sensitive Clean is a Manual Toothbrush with Antibacterial Bristles
2025-08-15
GUM Technique Sensitive Clean - GUM Technique Sensitive Clean is a Manual Toothbrush with Antibacterial Bristles
2025-08-15
GUM Technique Sensitive Clean - GUM Technique Sensitive Clean is a Manual Toothbrush with Antibacterial Bristles
2025-08-15
GUM Technique Sensitive Clean - GUM Technique Sensitive Clean is a Manual Toothbrush with Antibacterial Bristles
2025-08-15
GUM Technique Deep Clean - GUM Technique Deep Clean Compact Toothbrush
2025-05-19
GUM Technique Sensitive Clean - GUM Technique Sensitive Clean Compact Toothbrush, 1 CT
2025-05-19
GUM Technique Sensitive Clean - GUM Technique Sensitive Clean Compact Toothbrush
2025-05-19
GUM Technique Sensitive Clean - GUM Technique Sensitive Clean Compact Toothbrush, 1 CT
2025-05-19
GUM Technique Sensitive Clean - GUM Technique Sensitive Clean Compact Toothbrush
2025-05-19
GUM Technique Deep Clean - GUM Technique Deep Clean Compact Toothbrush
2025-05-19
GUM® - PROXABRUSH GO-BETWEENS SYSTEM
2022-11-10
GUM® - CRAYOLA TRAVEL TOOTHBRUSH SOFT
2022-11-10
GUM® - This standard US Ortho Kit for Professional Sales includes:* Code 632DB: Soft Pick US Professional 72 CT* Code 124PD: Orthodontic Toothbrush* Code 723PD: OrthoWax Unflavored 2 DZ* Code 1840PC Flossthreader* Code 1815PQB: Pro-Weave Mint, 4 yards* Code 3614PQ: Proxabrush Wide
2025-01-08
GUM® - US Professional Dental Sample Kit comprised of1 x 525PHS Deep Clean Technique Toothbrush1x 2030PQA Expanding Floss1 x 828PQ Twisted Mint Flosser1 x 872PQ Proxabrush Tight Interdental Brush1 x 3612PQ Proxabrush Moderate Interdental Brush1 x 650PA Soft Pick Advanced Interdental Pick1 x 308PD End Tuft Toothbrush1 x 600PYC Rubber Tip Stimulator1 x 760PB Tongue Cleaner /Scraper1 x 895 PQ Crayola Kids Flosser1 x 227A Crayola Marker Toothbrush
2024-10-30
GUM - Sample Kit containing 135RA1 Multi-Clean Toothbrush828PQ Twisted Mint® Floss Picks sample pack649PA Soft-Picks® Advanced Tight sample pack
2024-10-04
GUM - 135RA1 Multi-Clean Toothbrush828PQ Twisted Mint® Floss Picks sample pack649PA Soft-Picks® Advanced Tight sample pack
2024-10-04
GUM - 135RA1 Multi-Clean Toothbrush828PQ Twisted Mint® Floss Picks sample pack649PA Soft-Picks® Advanced Tight sample pack
2024-10-04
GUM® - RED-COTE® Plaque Disclosing Tablets
2021-08-29
GUM® - CRAYOLA POWER TOOTHBRUSH SOFT
2022-11-10