FDA.reportPublic FDA data

GUM®

Primary DI
00070942006255
Brand
GUM®
Company
SUNSTAR AMERICAS, INC.
Model
625
Catalog number
RQ
Device description
PROXABRUSH GO-BETWEENS SYSTEM
Published
2022-11-10
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
EFWTOOTHBRUSH, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFWToothbrush, ManualDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00070942007658PackageGS14In Commercial Distribution
10070942006252PackageGS16In Commercial Distribution
20070942007652PackageGS14Not in Commercial Distribution
00070942006255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00070942007658000709420076580709420076580070942007658
1007094200625210070942006252
2007094200765220070942007652
00070942006255000709420062550709420062550070942006255

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal pick/brush, reusableA manual, pointed, oral hygiene device with a soft tip or bristles intended to be used to stimulate and massage the gums to promote good periodontal (gum) condition, and to clean and remove plaque and debris from between the teeth and gingival surfaces. It may also be referred to as an interdental/interproximal brush and is intended for use in the home. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth12Millimeter
Height208.6Millimeter
Width12Millimeter

Contacts#

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

Regulatory Flags#

DUNS number
025066358
Device count
1
Premarket exempt
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
00070942002783GUM®228RQT2022-11-10
00070942008143GUM® ORTHKITPRB2025-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889483565599BALLARD™SUNMED, LLCEFW2026-01-12
00070942007368GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
00070942007412GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
00070942008099GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
10304040192471Henry ScheinHENRY SCHEIN, INC.EFW2025-07-08
20371347019531Advance Dental ProductsThe Atlanta Dental Supply CompanyEFW2025-06-25
00072239331057Dr. Brown'sDr. Brown's CompanyEFW2025-05-23
00072239330418Dr. Brown'sDr. Brown's CompanyEFW2025-05-22
00070942006378GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-05-19
00070942008105GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-05-19
00070942008112GUM Technique Deep CleanSUNSTAR AMERICAS, INC.EFW2025-05-19
10810063756243KIDS BUDDY ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756250Power Curve ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756267Esprit Ultra Fine ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756274Whisper Tech Ultra-Fine ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756281Power Curve ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756403Power Curve Extra-Soft ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756434KIDS BUDDY ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756588Jr Series Comfort Grip ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756595Power Curve Extra-Soft ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756175Euro Tech Compact Sensitive ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756205Endeavor ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756212Vital Fresh ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756229Aspire Compact ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756236PlaquePRO Interdental Proxy BrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756397Polisher Compact ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756533Soft Flex ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756540Glisten Junior ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756557Curve Contour ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756564Silhouette ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18