Question 1

What types of medical devices does O&S Dental, Inc. manufacture?

Accepted Answer

O&S Dental, Inc. specializes in orthodontic retainers, which are devices used primarily to maintain dental alignment after orthodontic treatment. Their most common product category is orthodontic retainers, such as the TopSticks Mini and TopSeparators, designed to help stabilize teeth in their corrected positions.

Question 2

Where is O&S Dental, Inc. based?

Accepted Answer

O&S Dental, Inc. is based in the United States. This location is relevant for understanding the company’s regulatory and operational context, particularly when considering compliance with US and international standards.

Question 3

Are O&S Dental, Inc.’s devices listed in any regulatory registries?

Accepted Answer

Yes, O&S Dental, Inc.’s devices are listed in the EUDAMED database. EUDAMED is the European Union’s medical device registry, which tracks devices authorized for sale within the EU. Listing here indicates compliance with EU regulatory requirements for Class I devices.

Question 4

How are O&S Dental, Inc.’s devices classified under EU regulations?

Accepted Answer

O&S Dental, Inc.’s devices, such as the TopSticks Mini and TopSeparators, are classified as Class I under EU medical device regulations. This classification applies to low-risk devices like orthodontic retainers, which typically require less stringent regulatory oversight compared to higher-risk categories.

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Device	Model / Reference	Registries	Class	Status
TopChain	323-026	EUDAMED	Class I	Active
TopChain	323-015	EUDAMED	Class I	Active
TopSticks Mini	340-003	EUDAMED	Class I	Active
TopChain	321-006	EUDAMED	Class I	Active
TopSticks Mini	340-029	EUDAMED	Class I	Active
TopChain	321-049	EUDAMED	Class I	Active
TopSticks	320-014	EUDAMED	Class I	Active
TopSticks	320-046	EUDAMED	Class I	Active
TopSticks	320-039	EUDAMED	Class I	Active
TopSticks	320-027	EUDAMED	Class I	Active
TopSticks	320-023	EUDAMED	Class I	Active
TopSticks	320-029	EUDAMED	Class I	Active
TopChain	321-002	EUDAMED	Class I	Active
Elastomerics	320-013	EUDAMED	Class I	Active
TopSticks	320-032	EUDAMED	Class I	Active
TopSticks	320-041	EUDAMED	Class I	Active
Top-Elastics City Series Latex-Free	352-3880	EUDAMED	Class I	Active
TopSticks	320-020	EUDAMED	Class I	Active
TopSticks	320-002	EUDAMED	Class I	Active
TopSticks	320-043	EUDAMED	Class I	Active
TopSticks	320-006	EUDAMED	Class I	Active
TopSticks	320-033	EUDAMED	Class I	Active
TopSticks	320-034	EUDAMED	Class I	Active
TopSticks	320-019	EUDAMED	Class I	Active
TopSticks	320-042	EUDAMED	Class I	Active
Orthodontic Wax	370-000	EUDAMED	Class I	Active
TopSticks	320-012	EUDAMED	Class I	Active
Top Sticks	320-003	EUDAMED	Class I	Active
TopSticks	320-011	EUDAMED	Class I	Active
TopSticks	320-017	EUDAMED	Class I	Active
Top Sticks	320-004	EUDAMED	Class I	Active
TopSticks	320-018	EUDAMED	Class I	Active
TopChain	321-004	EUDAMED	Class I	Active
TopSticks	320-036	EUDAMED	Class I	Active