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
Ortho Resuable Tongue Scraper Rose Gold	10000005	FDA UDI	Class I	Active
Super Mint Ortho Floss Fluoride	0700205056	FDA UDI	Class I	Active
Super Mint Mouth Floss Fluoride	0700205001	FDA UDI	Class I	Active
S-Bristles Nylon Brushhead Green, Moler Musical Kid’s Sonic Toothbrush Refill	38000005	FDA UDI	Class I	Active
Superbrush Tangerine Clean Toothbrush	04000004	FDA UDI	Class I	Active
Strawberry Kids Tongue Scraper Single Scoop	1002404001	FDA UDI	Class I	Active
Musical Sonic Toothbrush 4-Songs Cavitar	0401301007	FDA UDI	Class I	Active
Smile Sidekick Replacement Head Nylon Dr. H.O.S.S	38000011	FDA UDI	Class I	Active
Adult Tongue Scraper	1000601001	FDA UDI	Class I	Active
Smile Sidekick Sonic Toothbrush Melo-D	0402001026	FDA UDI	Class I	Active
Super Vanilla Mouth Floss Non-Fluoride	0700002001	FDA UDI	Class I	Active
Superbrush Bluetooth Brush Junior	04000001	FDA UDI	Class I	Active
0-36 Months Brush Nylon Head For Turbo Junior and Girl Toothbrushes Regular	38000006	FDA UDI	Class I	Active
Strawberry Kids Tongue Scraper Double Scoops	1002504001	FDA UDI	Class I	Active
S-Bristles Nylon Brushhead Clear, Tooth Keri Glow Globe Refill	38000002	FDA UDI	Class I	Active
Moler 4 Songs Kids Toothbrush	0401601008	FDA UDI	Class I	Active
Ultim8 Sonic Toothbrush & UV Sanitizer with Travel Case Gift Box Blue	12000021	FDA UDI	Class I	Active
Ultim8 Sonic Toothbrush & UV Sanitizer Gift Box Blue	12000018	FDA UDI	Class I	Active
Vanilla Kids Tongue Scraper Single Scoop	1002402001	FDA UDI	Class I	Active
UV Travel Case FOR Adult Electric Toothbrush White	12000007	FDA UDI	Class I	Active
Super Strawberry Mouth Floss Non-Fluoride	0700104040	FDA UDI	Class I	Active
Ultim8 Sonic Pearly White Toothbrush & UV Sanitizer Box Set	12000026	FDA UDI	Class I	Active
Ortho Resuable Tongue Scraper Silver	10000004	FDA UDI	Class I	Active
Superbrush Ortho Manual Toothbrush Silver	04000008	FDA UDI	Class I	Active
UV Travel Case FOR Adult Electric Toothbrush Rose Gold	12000013	FDA UDI	Class I	Active
Bristles Electric Replacement PBT Brush Head Regular	38000016	FDA UDI	Class I	Active
Baby Bristle Rattle	2600901018	FDA UDI	Class I	Active
Chocolate Kids Tongue Scraper Single Scoop	1002403001	FDA UDI	Class I	Active
Superbrush Breath Mint Toothbrush	04000005	FDA UDI	Class I	Active
Adult Ortho Replaceable Brush head S Bristles White	38000021	FDA UDI	Class I	Active
Glow Globe Toobrush Tooth Keri	0402601025	FDA UDI	Class I	Active
Ultim8 Sonic Toothbrush & UV Sanitizer with Travel Case Gift Box White	12000020	FDA UDI	Class I	Active
Ortho Tongue scraper Rose Gold	10000002	FDA UDI	Class I	Active
Ultim8 Sonic Toothbrush & UV Sanitizer Gift Box Rose Gold	12000019	FDA UDI	Class I	Active
Super StrawberryOrtho Floss Fluoride	0700204056	FDA UDI	Class I	Active
Musical Sonic Toothbrush 4-Songs Moler	0401301008	FDA UDI	Class I	Active
Adult Ortho Replaceable Brush head S Bristles Rose Gold	38000024	FDA UDI	Class I	Active
Smile Sidekick Sonic Toothbrush Dr. H.O.S.S	0402001024	FDA UDI	Class I	Active
Ultim8 Sanitizer UV Blue	12000001	FDA UDI	Class I	Active
White Water Flosser	12000023	FDA UDI	Class I	Active
Super Chocolate Mouth Floss Non-Fluoride	0700003001	FDA UDI	Class I	Active
Glow Globe ToothbrushCavitar/Moler	12000006	FDA UDI	Class I	Active
Ultim8 Adult White Rechargeable Sonic Toothbrush	0400701038	FDA UDI	Class I	Active
UV Travel Case FOR Adult Electric Toothbrush Blue	12000012	FDA UDI	Class I	Active
Cavitar 4 Songs Kids Toothbrush	0401601007	FDA UDI	Class I	Active
Super Chocolate Ortho Floss Fluoride	0700203056	FDA UDI	Class I	Active
Dr. Hoss 4 Song Kids Toothbrush	0401601024	FDA UDI	Class I	Active
Adult Ortho Replaceable Brush head S Bristles Blue	38000023	FDA UDI	Class I	Active
Glow Globe Toothbrush Dr. H.O.S.S	0402601024	FDA UDI	Class I	Active
Blue Water Flosser	12000024	FDA UDI	Class I	Active

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