Question 1

What types of medical devices does Edge Endo LLC manufacture?

Accepted Answer

Edge Endo LLC specializes in dental and medical devices. Their portfolio includes ultrasonic handpiece tips for scaling and endodontic procedures, single-use surgical face masks for medical/dental use, endodontic filling and sealing materials, temporary dental crowns/bridges (resin and pre-formed), dental cleaning solutions, and cryogenic dental sprays. These devices cater to both dental and surgical applications, with a focus on precision and procedural efficiency.

Question 2

Where is Edge Endo LLC based, and how does that affect its devices?

Accepted Answer

Edge Endo LLC is based in the United States, meaning its devices are subject to U.S. medical device regulations. The company’s products are designed and manufactured under these regulatory frameworks, ensuring compliance with FDA requirements for safety, performance, and quality. This includes adherence to classification standards like Class II and Unclassified (U) categories.

Question 3

Which regulatory registries or databases list Edge Endo LLC’s devices?

Accepted Answer

Edge Endo LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in regulatory oversight and market surveillance. This listing is essential for compliance and traceability under U.S. medical device regulations.

Question 4

How are Edge Endo LLC’s devices classified under FDA regulations?

Accepted Answer

Edge Endo LLC’s devices fall under FDA’s Class II and Unclassified (U) categories. Class II devices generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. Unclassified devices are those not yet assigned a risk level but are still subject to regulatory review. The classification determines the regulatory pathway and controls applied to each device.

Question 5

What distinguishes Edge Endo LLC’s endodontic and dental devices from others in the market?

Accepted Answer

Edge Endo LLC’s devices are tailored for specific dental and endodontic procedures, such as ultrasonic scaling, root canal sealing, and temporary restorations. For example, their ultrasonic handpiece tips (like EdgeTip™) are designed for precision in cleaning and debridement, while materials like EdgeSeal and EdgeCaOH are formulated for endodontic filling and sealing. These specialized products address niche needs in dental treatment, ensuring compatibility with procedural workflows and patient outcomes.

Device	Model / Reference	Registries	Class	Status
EdgeTip™ #2	ET18D	FDA UDI	Class II	Active
Edge™ EarLoop Procedure Masks	5722015	FDA UDI	Class II	Active
Edge™ EarLoop Procedure Masks	5722013	FDA UDI	Class II	Active
EdgeIce	EDGEICE	FDA UDI	Class II	Active
Edge™ EarLoop Procedure Masks	5722006	FDA UDI	Class II	Active
EdgeSeal Root Canal Sealer	EESEAL	FDA UDI	Class II	Active
Edge™ EarLoop Procedure Masks	5722352	FDA UDI	Class II	Active
EdgeTip™ #4	ET40D4	FDA UDI	Class II	Active
EdgeTip™ #3	ET20D	FDA UDI	Class II	Active
EdgeCaOH Calcium Hydroxide Root Canal Filling Material	EECAOH	FDA UDI	Class II	Active
EdgeTip™ #6	ET25S	FDA UDI	Class II	Active
Edge™ EarLoop Procedure Masks	5722008	FDA UDI	Class II	Active
EdgeCaOH Calcium Hydroxide Root Canal Filling Material	EECAOH	FDA UDI	Class II	Active
EdgeTemp Hydraulic Temporary Restorative	EETEMP	FDA UDI	Class II	Active
EdgeTemp Hydraulic Temporary Restorative	EETEMP	FDA UDI	Class II	Active
EdgeSeal Root Canal Sealer	EESEAL	FDA UDI	Class II	Active
Edge™ EarLoop Procedure Masks”	5722009	FDA UDI	Class II	Active
Edge™ EarLoop Procedure Masks	5722016	FDA UDI	Class II	Active
EdgeSurgical Tip™ #3	P15LD	FDA UDI	Class II	Active
EdgeSurgicalTip™ #2	AS3D2	FDA UDI	Class II	Active
EdgeTemp™ Plus Hydraulic Temporary Restorative Material	ETEMPPLUS	FDA UDI	Class II	Active
EdgeSurgicalTip™ #4	ASLD	FDA UDI	Class II	Active
Edge™ EarLoop Procedure Masks	5722017	FDA UDI	Class II	Active
EdgeTip™ #5	ET40D5	FDA UDI	Class II	Active
EdgeCaOH Calcium Hydroxide Root Canal Filling Material	EECAOH	FDA UDI	Class II	Active
Edta	EEEDTA	FDA UDI	U	Active
EdgeSurgicalTip™ #5	P15RD	FDA UDI	Class II	Active
EdgeTemp Hydraulic Temporary Restorative	EETEMP	FDA UDI	Class II	Active
EdgeEndo Chlohexidine	EECHX	FDA UDI	U	Active
EdgeTip™ #8	ET25L	FDA UDI	Class II	Active
EdgeTip™ #1	ETBD	FDA UDI	Class II	Active
EdgeTip™ #7	ET25	FDA UDI	Class II	Active
EdgeEndo Sodium Hypochloite	EENAOCL	FDA UDI	U	Active
EdgeSeal Root Canal Sealer	EESEAL	FDA UDI	Class II	Active
Edge™ EarLoop Procedure Masks	5722011	FDA UDI	Class II	Active
EdgeSurgicalTip™ #1	AS3D1	FDA UDI	Class II	Active
EdgeSurgicalTip™ #6	ASRD	FDA UDI	Class II	Active

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