FDA.reportPublic FDA data

Superbrush Ortho Manual Toothbrush Rose Gold

Primary DI
00810131040505
Brand
Superbrush Ortho Manual Toothbrush Rose Gold
Company
Supermouth LLC
Model
04000007
Device description
Orthodontic Manual Toothbrush Rose Gold
Published
2024-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810131040505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810131040505008101310405058101310405050810131040505

GMDN Terms#

Term, Definition table
TermDefinition
Basic manual toothbrushAn instrument designed to be used by a patient to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device is typically used with toothpaste. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
049384038
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810131045319Ultim8 Adult Ortho Sonic Rechargeable Toothbrush Pearly White 40000222025-12-02
00810131045326Ultim8 Adult Ortho Sonic Rechargeable Toothbrush Saphire Blue40000232025-12-02
00810131045333Ultim8 Adult Ortho Sonic Rechargeable Toothbrush Rose Gold40000242025-12-02
00810131044190Ultim8 Adult Rose Gold Sonic Rechargeable Toothbrush40000172025-06-30
00810131044725Adult SuperScraper Silver100000072025-06-30
00810131044732Adult SuperScraper Rose Gold100000082025-06-30
00850036799993Ultim8 Sonic Pearly White Toothbrush & UV Sanitizer Box Set 120000262025-06-30
00810131041502Adult Resuable Tongue Scraper 100000032025-05-25
00810131041519Ortho Resuable Tongue Scraper Silver100000042025-05-25
00810131041526Ortho Resuable Tongue Scraper Rose Gold100000052025-05-25
00810131040000Super Vanilla Ortho Floss Fluoride07002020562024-06-01
00810131040017Super StrawberryOrtho Floss Fluoride07002040562024-06-01
00810131040024Super Mint Ortho Floss Fluoride07002050562024-06-01
00810131040031Super Chocolate Ortho Floss Fluoride07002030562024-06-01
00810131040215Superbrush Bluetooth Brush Junior040000012024-06-01
00810131040222Superbrush Orange A Peel Brush Junior040000022024-06-01
00810131040239Superbrush Yellow Sunshine Brush Junior040000032024-06-01
00810131040246Superbrush Tangerine Clean Toothbrush040000042024-06-01
00810131040253Superbrush Breath Mint Toothbrush040000052024-06-01
00810131040260Superbrush Blue Biome Toothbrush040000062024-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10889483565599BALLARD™SUNMED, LLCEFW2026-01-12
00070942007368GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
00070942007412GUM 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
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