Question 1

What types of dental devices does Beijing Yingguan Dental Technology Co., Ltd. manufacture?

Accepted Answer

Beijing Yingguan Dental Technology Co., Ltd. specializes in dental restorations and prosthetics, including metal-polymer and metal-ceramic bridges, custom-made metal crowns, and root canal post kits. Their product range also covers complete and partial dentures (both upper and lower), CAD/CAM resin and PEEK-based crowns and pontics, non-noble dental casting alloys, flexible dentures, and light-cured resin crowns. These devices are designed to address common dental restoration needs like tooth replacement, structural support, and aesthetic improvements.

Question 2

Where is Beijing Yingguan Dental Technology Co., Ltd. based, and how does this affect its regulatory compliance?

Accepted Answer

The company is based in the United States, which means its devices must comply with U.S. regulatory requirements, including those set by the FDA. Since the U.S. has strict oversight for medical devices, the company’s products are classified under FDA categories such as Class I (low-risk), Class II (moderate-risk requiring special controls), or exempt (N) from certain regulatory pathways. This classification ensures patient safety and device performance standards are met before market entry.

Question 3

Which regulatory registries list the devices manufactured by Beijing Yingguan Dental Technology Co., Ltd.?

Accepted Answer

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is a central repository for tracking and identifying medical devices in the U.S., ensuring transparency in the supply chain and aiding in post-market surveillance. Listing in the UDI database is required for most FDA-regulated devices to facilitate compliance and traceability.

Question 4

How are the dental devices from Beijing Yingguan Dental Technology Co., Ltd. classified under FDA regulations?

Accepted Answer

The company’s devices are classified under three main FDA categories: Class I (generally low-risk devices requiring general controls), Class II (moderate-risk devices needing special controls to ensure safety and effectiveness), or exempt (N) from certain regulatory requirements. Classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with. For example, some dental crowns or bridges may fall under Class II due to their structural role in oral health, while simpler items like certain dental tools might qualify for exemption.

Device	Model / Reference	Registries	Class	Status
Cast Full Denture Noble Metal	/	FDA UDI	Class I	Active
Resin Crown	/	FDA UDI	N	Active
CAD/CAM Crown PEEK	/	FDA UDI	N	Active
Cast Pontic Co Cr	/	FDA UDI	N	Active
CAD/CAM Frame & Partial Denture Titanium Alloy	/	FDA UDI	N	Active
SLM Crown Co Cr	/	FDA UDI	N	Active
CAD/CAM Post & Core Pure Titanium	/	FDA UDI	N	Active
CAD/CAM Fused Resin Pontic Co Cr	/	FDA UDI	N	Active
CAD/CAM Fused Resin Crown Ni-Cr	/	FDA UDI	N	Active
Cast Crown Pure Tianium	/	FDA UDI	N	Active
Cast Crown Ni-Cr (NP)	/	FDA UDI	N	Active
FMC Post & Core	/	FDA UDI	N	Active
CAD/CAM Crown Ni-Cr	/	FDA UDI	N	Active
CAD/CAM Full Denture PEEK	/	FDA UDI	Class II	Active
PFM Crown Co Cr (NP)	/	FDA UDI	N	Active
CAD/CAM PFM Pontic Pure Titanium	/	FDA UDI	N	Active
CAD/CAM Pontic Zirconia	/	FDA UDI	N	Active
CAD/CAM PFM Pontic Pure Titanium	/	FDA UDI	N	Active
SLM Full Denture Titanium Alloy	/	FDA UDI	N	Active
SLM Inlay Co Cr	/	FDA UDI	N	Active
Inlay Pure Titanium	/	FDA UDI	N	Active
SLM PFM Crown Co Cr	/	FDA UDI	N	Active
Resin Post & Core	/	FDA UDI	N	Active
FMC Pontic Ceramic	/	FDA UDI	N	Active
CAD/CAM Post & Core Ni-Cr	/	FDA UDI	N	Active
Cast Crown Co Cr (NP)	/	FDA UDI	N	Active
CAD/CAM Inlay Zirconia	/	FDA UDI	N	Active
Inlay Titanium Alloy	/	FDA UDI	N	Active
SLM PFM Pontic Co Cr	/	FDA UDI	N	Active
CAD/CAM Crown Zirconia	/	FDA UDI	N	Active
Resin Veneer	/	FDA UDI	N	Active
PFM Crown Ni-Cr (NP)	/	FDA UDI	N	Active
CAD/CAM Post & Core PEEK	/	FDA UDI	N	Active
SLM Bridge Co Cr	/	FDA UDI	N	Active
CAD/CAM Resin Veneer	/	FDA UDI	N	Active
Fused Resin Pontic Noble Metal	/	FDA UDI	N	Active
Cast Full Denture Co Cr	/	FDA UDI	N	Active
CAD/CAM Inlay Resin	/	FDA UDI	N	Active
CAD/CAM Full Denture Pure Titanium	/	FDA UDI	N	Active
FMC Veneer	/	FDA UDI	N	Active
Cast Pontic Pure Titanium	/	FDA UDI	N	Active
SLM Fused Resin Pontic Co Cr	/	FDA UDI	N	Active
CAD/CAM Inlay Pure Titanium	/	FDA UDI	N	Active
PFM Crown Noble Metal	/	FDA UDI	N	Active
CAD/CAM Full Denture Resin	/	FDA UDI	N	Active
Cast Pontic Ni-Cr	/	FDA UDI	N	Active
CAD/CAM Post & Core Resin	/	FDA UDI	N	Active
Cast Pontic Noble Metal	/	FDA UDI	N	Active
Wire Frame & Denture	/	FDA UDI	N	Active
Light-Cured Fused Resin Pontic	/	FDA UDI	N	Active

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