Question 1

What types of medical devices does Young Innovations, Inc. manufacture?

Accepted Answer

Young Innovations, Inc. specializes in orthodontic and dental devices. Their portfolio includes metal orthodontic bands and brackets, archwires, reusable diamond and carbide dental burs, orthodontic ligatures, specialized pliers, and single-use dental impression trays. These products are designed for clinical use in orthodontic and dental procedures.

Question 2

Where is Young Innovations, Inc. based?

Accepted Answer

Young Innovations, Inc. is headquartered in the United States. The company’s location is relevant for regulatory purposes, as it influences compliance requirements and reporting obligations under U.S. medical device regulations.

Question 3

Which regulatory registries or databases list Young Innovations, Inc.’s devices?

Accepted Answer

Young Innovations, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system ensures traceability and transparency in the supply chain, helping healthcare providers and regulators identify and verify devices.

Question 4

How are Young Innovations, Inc.’s devices classified under FDA regulations?

Accepted Answer

Young Innovations, Inc.’s devices fall under three FDA classification categories: Class I (generally low-risk devices requiring minimal regulation), Class II (moderate-risk devices with special controls to ensure safety and effectiveness), and Unclassified (U) devices (those not yet assigned a risk-based classification). Classification determines the regulatory pathway and oversight required for each product.

Device	Model / Reference	Registries	Class	Status
Tip BUC-1 Access	930-041	EUDAMEDFDA UDI	Class IIa	Active
Impression Tray Small Lower # 6	116130	EUDAMEDFDA UDI	Class I	Active
Pro-Tip Turbo (250)	116410	EUDAMEDFDA UDI	Class IIa	Active
Conversion Kit Sirona Sprayvit C8	QRNT1070	EUDAMEDFDA UDI	Class IIa	Active
Bite Trays Quadrant (40 pcs)	114142	EUDAMEDFDA UDI	Class I	Active
Starz Hp Pro Pak Amethyst Purple (1500 Tipz)	STZ917	EUDAMEDFDA UDI	Class IIa	Active
Luzzani LU135 Pro-Tip Coverter Kit Cefla	116235CEFLA	EUDAMEDFDA UDI	Class IIa	Active
Crystal Classic Rainbow (250 Tips)	CT1200	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Tray Size 6 Upper Purple	117150	EUDAMEDFDA UDI	Class I	Active
Pro-Matrix Sample Pack	19022	EUDAMEDFDA UDI	Class I	Active
Bite Trays Anterior (40 pcs) - Unodent	116139UNODENT	EUDAMEDFDA UDI	Class I	Active
EMS Threaded Tip CPR-2E	932-002	EUDAMEDFDA UDI	Class IIa	Active
Sirona Sprayvit SE137 Pro-Tip Converter Kit	116237ASTEK	EUDAMEDFDA UDI	Class IIa	Active
DCI DC110 Pro-Tip Converter Kit	116208ASTEK	EUDAMED	Class IIa	Active
Transform Tray - Edentulous - Medium Lower (12) #9	118209	EUDAMED	Class I	Active
Transform Tray - Dentate - Medium Upper (12) #4	118204	EUDAMED	Class I	Active
Impression Tray Medium Lower (25) #4 Unodent	116128UNODENT	EUDAMEDFDA UDI	Class I	Active
Impression Tray Small Upper # 5	116129	EUDAMEDFDA UDI	Class I	Active
Castellini CA152 Converter Kit Cefla	116345CEFLA	EUDAMED	Class IIa	Active
EMS Threaded Tip CPR-6E	932-006	EUDAMEDFDA UDI	Class IIa	Active
Pro-Matrix Curve - Wide (20pcs)	19028	EUDAMEDFDA UDI	Class I	Active
Tip KiS-5D Diamond	931-015	EUDAMEDFDA UDI	Class IIa	Active
Nasopharyngeal Swab with 80mm breakpoint	292496	EUDAMED	Class I	Active
Tip KiS-4D Diamond	931-014	EUDAMEDFDA UDI	Class IIa	Active
Impression Tray Large Lower (25) #2 Unodent	116126UNODENT	EUDAMEDFDA UDI	Class I	Active
Orthodontic Trays Assorted Uppers (60's) Unodent	117153UNODENT	EUDAMEDFDA UDI	Class I	Active

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