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.

Device	Model / Reference	Registries	Class	Status
TopChain	321-046	EUDAMED	Class I	Active
TopSticks Mini	340-008	EUDAMED	Class I	Active
TopChain	321-033	EUDAMED	Class I	Active
TopSticks Mini	340-001	EUDAMED	Class I	Active
TopChain	323-027	EUDAMED	Class I	Active
TopChain	321-008	EUDAMED	Class I	Active
TopSticks Mini	340-006	EUDAMED	Class I	Active
TopChain	321-031	EUDAMED	Class I	Active
TopChain	323-014	EUDAMED	Class I	Active
TopChain	321-047	EUDAMED	Class I	Active
TopElastics Latex-Free	352-1480	EUDAMED	Class I	Active
TopSticks Mini	340-033	EUDAMED	Class I	Active
TopElastics	350-1480	EUDAMED	Class I	Active
TopChain	321-011	EUDAMED	Class I	Active
TopChain	323-025	EUDAMED	Class I	Active
TopElastics	350-3635	EUDAMED	Class I	Active
TopElastics Latex-Free	352-1845	EUDAMED	Class I	Active
TopSticks Mini	340-032	EUDAMED	Class I	Active
TopChain	321-037	EUDAMED	Class I	Active
TopChain	321-016	EUDAMED	Class I	Active
TopChain	322-033	EUDAMED	Class I	Active
TopChain	322-032	EUDAMED	Class I	Active
TopChain	322-040	EUDAMED	Class I	Active
TopChain	321-032	EUDAMED	Class I	Active
TopChain	323-028	EUDAMED	Class I	Active
TopSticks Mini	340-049	EUDAMED	Class I	Active
TopSticks Mini	340-047	EUDAMED	Class I	Active
TopElastics	350-1435	EUDAMED	Class I	Active
TopSticks Mini	340-025	EUDAMED	Class I	Active
TopChain	321-005	EUDAMED	Class I	Active
TopChain	322-020	EUDAMED	Class I	Active
TopChain	322-041	EUDAMED	Class I	Active
TopChain	322-045	EUDAMED	Class I	Active
TopSticks Mini	340-005	EUDAMED	Class I	Active
TopChain	322-009	EUDAMED	Class I	Active
TopChain	323-035	EUDAMED	Class I	Active
TopSticks Mini	340-020	EUDAMED	Class I	Active
TopChain	322-046	EUDAMED	Class I	Active
TopElastics Latex-Free	352-3680	EUDAMED	Class I	Active
TopChain	322-036	EUDAMED	Class I	Active
TopElastics	350-3880	EUDAMED	Class I	Active
TopChain	322-035	EUDAMED	Class I	Active
TopChain	323-029	EUDAMED	Class I	Active
TopChain	323-034	EUDAMED	Class I	Active
TopSticks Mini	340-042	EUDAMED	Class I	Active
TopElastics Latex-Free	352-1825	EUDAMED	Class I	Active
TopSticks Mini	340-015	EUDAMED	Class I	Active
TopChain	323-012	EUDAMED	Class I	Active
TopChain	323-019	EUDAMED	Class I	Active
TopChain	321-045	EUDAMED	Class I	Active

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