FDA.reportPublic FDA data

Smile Sidekick Sonic Toothbrush Tooth Keri

Primary DI
00850036799412
Brand
Smile Sidekick Sonic Toothbrush Tooth Keri
Company
Supermouth LLC
Model
0402001025
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
00850036799412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850036799412008500367994128500367994120850036799412

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
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