Question 1

What types of oral hygiene products does Supermouth LLC manufacture?

Accepted Answer

Supermouth LLC specializes in a range of oral hygiene products, including basic electric and manual toothbrushes, reusable tongue scrapers, dental floss dispensers, and oral lavage systems. Their portfolio also extends to infant care items like teething devices and oral care kits for children, as well as themed and musical toothbrushes designed specifically for kids. These products are developed to support daily oral care routines for various age groups.

Question 2

Where is Supermouth LLC based, and what markets do its devices target?

Accepted Answer

Supermouth LLC is based in the United States. Their devices are designed and intended for use within the U.S. market, where they must comply with applicable regulatory requirements for medical devices. The company’s product line is tailored to meet common oral hygiene needs across different demographics, including adults and children.

Question 3

Which regulatory registries list Supermouth LLC’s devices?

Accepted Answer

Supermouth LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the United States, ensuring transparency and traceability in the regulatory system. The UDI system helps healthcare providers, regulators, and manufacturers manage device information efficiently.

Question 4

How are Supermouth LLC’s devices classified under FDA regulations?

Accepted Answer

Supermouth LLC’s devices fall under two primary FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and often require only general controls, while Class II devices involve a higher level of risk and may require special controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body’s interaction with it, as outlined in FDA guidelines.

Question 5

What distinguishes Supermouth LLC’s product line in terms of design and functionality?

Accepted Answer

Supermouth LLC’s product line stands out due to its focus on accessibility and variety, offering both basic and specialized oral care solutions. For example, their electric toothbrushes include sonic and musical designs for kids, while their floss variants come in fluoride and non-fluoride options. Reusable tongue scrapers and themed brushes (like color-coded or flavor-themed designs) cater to preferences and hygiene needs across different user groups, emphasizing practicality and user engagement.

Device	Model / Reference	Registries	Class	Status
Smile Sidekick Replacement Head Nylon Tooth Keri	38000010	FDA UDI	Class I	Active
Ultim8 Sonic Toothbrush & UV Sanitizer Gift Box White	12000017	FDA UDI	Class I	Active
Adult SuperScraper Silver	10000007	FDA UDI	Class I	Active
3 to 6 Years Brush Nylon Head For Turbo Junior and Girl Toothbrushes Regular	38000007	FDA UDI	Class I	Active
Superbrush Ortho Manual Toothbrush Rose Gold	04000007	FDA UDI	Class I	Active
Cavitar Moler Glow Globe Replacement Brush Head	38000022	FDA UDI	Class I	Active
Adult Replacement Brushhead, S-Bristles Rechargeable TB - White with Blue nodes	38000018	FDA UDI	Class I	Active
Tooth Keri 4 Songs Kids Toothbrush	0401601025	FDA UDI	Class I	Active
Smile Sidekick Replacement Head Nylon Melo-D	38000009	FDA UDI	Class I	Active
Smile Sidekick Replacement Head Nylon Cavitar	38000008	FDA UDI	Class I	Active
Smile Sidekick Replacement Head Nylon Dr. H.O.S.S "S" Bristles	38000015	FDA UDI	Class I	Active
Superbrush Yellow Sunshine Brush Junior	04000003	FDA UDI	Class I	Active
Adult Replacement Brushhead, S-Bristles Rechargeable TB -White with Rose Gold n	38000020	FDA UDI	Class I	Active
Super Mint Mouth Floss Non-Fluoride	0700005001	FDA UDI	Class I	Active
Rose Gold Water Flosser	12000025	FDA UDI	Class I	Active
Smile Sidekick Sonic Toothbrush Tooth Keri	0402001025	FDA UDI	Class I	Active
Melo-D 4 Song Kids Toothbrush	0401601026	FDA UDI	Class I	Active
Smile Sidekick Sonic Toothbrush Cavitar	0402001007	FDA UDI	Class I	Active
Chocolate Kids Tongue Scraper Double Scoops	1002503001	FDA UDI	Class I	Active
Adult Resuable Tongue Scraper	10000003	FDA UDI	Class I	Active
Bristle The Brushineer Caddy Toothbrush	1401301018	FDA UDI	Class I	Active
Super Vanilla Mouth Floss Fluoride	0700202001	FDA UDI	Class I	Active
Ultim8 Sonic Toothbrush & UV Sanitizer with Travel Case Gift Box Rose Gold	12000022	FDA UDI	Class I	Active
Ultim8 Adult Rose Gold Sonic Rechargeable Toothbrush	4000011	FDA UDI	Class I	Active
Castle Teething Ring	501101001	FDA UDI	Class II	Active
Super Vanilla Ortho Floss Fluoride	0700202056	FDA UDI	Class I	Active
Ultim8 Adult Blue Sonic Rechargeable Toothbrush	4000010	FDA UDI	Class I	Active
Turbo Sonic Toothbrush	0402101021	FDA UDI	Class I	Active
Super Strawberry Mouth Floss Fluoride	0700204001	FDA UDI	Class I	Active
Ortho Tongue scraper Silver	10000001	FDA UDI	Class I	Active
Baby Bristles Teether	501501018	FDA UDI	Class I	Active
Ultim8 Adult Rose Gold Sonic Rechargeable Toothbrush	4000017	FDA UDI	Class I	Active
S-Bristles Nylon Brushhead Grey, Father Turbo Refill	38000003	FDA UDI	Class I	Active
Bristles Electric Replacement PBT Brush Head "S" Bristles	38000017	FDA UDI	Class I	Active
Peekaboo Teething Ring	501201001	FDA UDI	Class I	Active
Adult SuperScraper Rose Gold	10000008	FDA UDI	Class I	Active
Super Chocolate Mouth Floss Fluoride	0700203001	FDA UDI	Class I	Active
S-Bristles Nylon Brushhead Clear, Dr Hoss Glow Globe Refill	38000001	FDA UDI	Class I	Active
Toddler Ultra Soft Kids Manual Toothbrush Tooth Keri	'04000012	FDA UDI	Class I	Active
Superbrush Blue Biome Toothbrush	04000006	FDA UDI	Class I	Active
Ultim8 Sanitizer UV White	1200701037	FDA UDI	Class I	Active
Bristles 4 Song Kids Toothbrush	0401601018	FDA UDI	Class I	Active
Smile Sidekick Replacement Head Nylon Cavitar "S" Bristles	38000012	FDA UDI	Class I	Active
Superbrush Orange A Peel Brush Junior	04000002	FDA UDI	Class I	Active
Smile Sidekick Replacement Head Nylon Tooth Keri "S" Bristles	38000014	FDA UDI	Class I	Active
Ultim8 Sanitizer UV Rose Gold	12000002	FDA UDI	Class I	Active
Vanilla Kids Tongue Scraper Double Scoops	1002502001	FDA UDI	Class I	Active
S-Bristles Nylon Brushhead Red, Cavitar Musical Kid’s Sonic Toothbrush Refill	38000004	FDA UDI	Class I	Active
Smile Sidekick Replacement Head Nylon Melo-D "S" Bristles	38000013	FDA UDI	Class I	Active

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