FDA.reportPublic FDA data

GUM®

Primary DI
00070942008143
Brand
GUM®
Company
SUNSTAR AMERICAS, INC.
Model
ORTHKITPRB
Device description
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
Published
2025-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFWToothbrush, Manual
EGDWax, Dental, Intraoral
JESFloss, Dental
JETPick, Massaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFWToothbrush, ManualDental1
EGDWax, Dental, IntraoralDental1
JESFloss, DentalDental1
JETPick, MassagingDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00070942008143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00070942008143000709420081430709420081430070942008143

GMDN Terms#

Term, Definition table
TermDefinition
Dental flossA string-like device formed as thread or tape, used for the removal of plaque and/or debris from the proximal surfaces of teeth and the gingival surfaces of fixed prostheses. It is typically made of a synthetic fibre. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7733554024paula.wendland@us.sunstar.com

Regulatory Flags#

DUNS number
025066358
Device count
1
Kit
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00070942005265GUM®3615BQ2023-01-26
00070942006491GUM®3615PQA2023-12-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06931718175657HIT PROMOTIONAL PRODUCTS, INC.New Phenix Home Products Manufactory Co., Ltd.JES2026-06-23
06931718175664HIT PROMOTIONAL PRODUCTS, INC.New Phenix Home Products Manufactory Co., Ltd.JES2026-06-23
06931718175671HIT PROMOTIONAL PRODUCTS, INC.New Phenix Home Products Manufactory Co., Ltd.JES2026-06-23
00840456200193JMUJMU DENTAL, INCEGD2026-06-22
00840456224144JMUJMU DENTAL, INCEGD2026-06-22
00840456224151JMUJMU DENTAL, INCEGD2026-06-22
00840456224168JMUJMU DENTAL, INCEGD2026-06-22
00840456224175JMUJMU DENTAL, INCEGD2026-06-22
00840456224182JMUJMU DENTAL, INCEGD2026-06-22
00072239332559Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239332566Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239332573Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239332580Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239334812Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239334829Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239334836Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239328002Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239328149Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239330050Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239332313Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239332320Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239332535Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239332542Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239333129Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
EYET6530500M0 Sculp. Wax SPECIAL-Summer-Pink, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET65505000 Sculp. Wax SPEZIAL winter Pink, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET6550500M0 Sculp. Wax SPEZIAL winter Pink, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET66005000 Sculp. Wax SUPERPINK elastic, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET6600500M0 Sculp. Wax SUPERPINK elastic, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET68000000SOLIDUS 80, base plate wax sheet, SampleYeti Dentalprodukte GmbHEGD2026-05-20