FDA.reportPublic FDA data

GUM®

Primary DI
00070942005395
Brand
GUM®
Company
SUNSTAR AMERICAS, INC.
Model
4110
Catalog number
URB
Device description
Sonic Deep Clean Refills, Black, 2-pack
Published
2023-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JESFLOSS, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JESFloss, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10070942005392PackageGS14In Commercial Distribution
00070942005395PrimaryGS10
80070942005391Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007094200539210070942005392
00070942005395000709420053950709420053950070942005395
8007094200539180070942005391

GMDN Terms#

Term, Definition table
TermDefinition
Basic electric toothbrushAn electrically-powered device designed to be used by a patient to brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and an exchangeable distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device provides automated bristle movement (e.g., rotary or vibratory) intended to augment brushing, and is typically used with toothpaste. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height75.8Millimeter

Contacts#

Phone, Email table
PhoneEmail
+1(800)777-3101contact.us@us.sunstar.com

Regulatory Flags#

DUNS number
025066358
Device count
2
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00070942005425GUM®4100UTWA2023-06-14
00070942005432GUM®4100UTBA2023-06-14
00070942008822GUM® Expanding Floss2030R42026-05-01
00070942008952GUM® Professional Clean Floss1820RA2026-04-30
00070942783354GUM®9934RA2024-03-12
10070942003695GUM® CRAYOLA TWISTABLES FLOSSERS853PA2025-11-04
00070942007368GUM Technique Sensitive Clean527TPA12025-08-15
00070942007412GUM Technique Sensitive Clean527TRA22025-08-15
00070942008099GUM Technique Sensitive Clean527CNL2025-08-15
10070942007365GUM Technique Sensitive Clean527TPA12025-08-15
10070942007419GUM Technique Sensitive Clean527TRA22025-08-15
20070942008093GUM Technique Sensitive Clean527CNL2025-08-15
00070942008112GUM Technique Deep Clean5255252025-05-19
00070942006378GUM Technique Sensitive Clean524TPA1524TPA12025-05-19
00070942008105GUM Technique Sensitive Clean524CNL524CNL2025-05-19
20070942006372GUM Technique Sensitive Clean524TPA1524TPA12025-05-19
20070942008109GUM Technique Sensitive Clean524CNL524CNL2025-05-19
20070942008116GUM Technique Deep Clean5255252025-05-19
00070942006255GUM®625RQ2022-11-10
00070942002783GUM®228RQT2022-11-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00070942008822GUM® Expanding FlossSUNSTAR AMERICAS, INC.JES2026-05-01
00070942008952GUM® Professional Clean FlossSUNSTAR AMERICAS, INC.JES2026-04-30
10070942003695GUM® CRAYOLA TWISTABLES FLOSSERSSUNSTAR AMERICAS, INC.JES2025-11-04
10371347019732Advance Dental ProductsThe Atlanta Dental Supply CompanyJES2025-10-01
10371347019749Advance Dental ProductsThe Atlanta Dental Supply CompanyJES2025-10-01
20371347019531Advance Dental ProductsThe Atlanta Dental Supply CompanyJES2025-06-25
10810063755567Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
10810063756182Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
10810063756199Floss PicksSAFCO DENTAL SUPPLY CO.JES2025-03-18
10810063756656Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
10810063756663Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
10304040189853Henry ScheinHENRY SCHEIN, INC.JES2025-01-30
10304040189860Henry ScheinHENRY SCHEIN, INC.JES2025-01-30
10304040189877Henry ScheinHENRY SCHEIN, INC.JES2025-01-30
10304040189884Henry ScheinHENRY SCHEIN, INC.JES2025-01-30
00032251933462Family WellnessFamily Dollar StoresJES2024-05-03
00032251933486Family WellnessFamily Dollar StoresJES2024-05-03
00032251933493Family WellnessFamily Dollar StoresJES2024-05-03
00032251933523Family WellnessFamily Dollar StoresJES2024-05-03
00032251933479Family WellnessFamily Dollar StoresJES2024-04-09
00032251933509Family WellnessFamily Dollar StoresJES2024-04-09
00070942007153GUM®SUNSTAR AMERICAS, INC.JES2024-04-05
00070942007177GUM®SUNSTAR AMERICAS, INC.JES2024-04-05
00070942006590GUM®SUNSTAR AMERICAS, INC.JES2024-03-15
00070942006552GUM®SUNSTAR AMERICAS, INC.JES2024-03-14
00070942006576GUM®SUNSTAR AMERICAS, INC.JES2024-03-13
00070942006514GUM®SUNSTAR AMERICAS, INC.JES2024-03-12
00070942006613GUM®SUNSTAR AMERICAS, INC.JES2024-03-12
00070942006606GUM®SUNSTAR AMERICAS, INC.JES2024-03-07
00070942006583GUM®SUNSTAR AMERICAS, INC.JES2024-03-05