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
CAD/CAM Crown Resin	/	FDA UDI	N	Active
PFM Pontic Pure Titanium	/	FDA UDI	N	Active
Cast Frame & Partial Denture Co Cr	/	FDA UDI	N	Active
PFM Pontic Noble Metal	/	FDA UDI	N	Active
CAD/CAM Crown Co Cr	/	FDA UDI	N	Active
Cast Frame & Partial Denture Pure Titanium	/	FDA UDI	N	Active
CAD/CAM Fused Resin Crown PEEK	/	FDA UDI	N	Active
Cast Crown Noble Metal	/	FDA UDI	N	Active
CAD/CAM Fused Resin Pontic PEEK	/	FDA UDI	N	Active
CAD/CAM Fused Resin Crown Titanium Alloy	/	FDA UDI	N	Active
Flexible Denture	/	FDA UDI	N	Active
Light-Cured Fused Resin Crown	/	FDA UDI	N	Active
PFM Pontic Co Cr	/	FDA UDI	N	Active
FMC Inlay	/	FDA UDI	N	Active
All-Ceramic Crown	/	FDA UDI	N	Active
PFM Crown Pure Titanium	/	FDA UDI	N	Active
CAD/CAM Pontic Glass Ceramic	/	FDA UDI	N	Active
CAD/CAM PFM Pontic Co Cr	/	FDA UDI	N	Active
PFM Veneer	/	FDA UDI	N	Active
CAD/CAM PFM Crown Titanium Alloy	/	FDA UDI	N	Active
Cast Full Denture Pure Titanium	/	FDA UDI	N	Active
CAD/CAM Veneer Zirconia	/	FDA UDI	N	Active
Post & Core Pure Titanium	/	FDA UDI	N	Active
Full Resin Denture	/	FDA UDI	N	Active
CAD/CAM PFM Pontic Ni-Cr	/	FDA UDI	N	Active
FMC Crown	/	FDA UDI	N	Active
Surgical Stent Implant	/	FDA UDI	Class I	Active
Inlay Noble Metal	/	FDA UDI	N	Active
Post & Core Ni-Cr	/	FDA UDI	N	Active
CAD/CAM PFM Crown Co Cr	/	FDA UDI	N	Active
CAD/CAM PFM Pontic Ni-Cr	/	FDA UDI	N	Active
CAD/CAM Frame & Partial Denture PEEK	/	FDA UDI	Class II	Active
CAD/CAM Crown Titanium Alloy	/	FDA UDI	N	Active
CAD/CAM PFM Pontic Titanium Alloy	/	FDA UDI	N	Active
Post & Core Co Cr	/	FDA UDI	N	Active
CAD/CAM Fused Resin Pontic Pure Titanium	/	FDA UDI	N	Active
CAD/CAM Post & Core Co Cr	/	FDA UDI	N	Active
CAD/CAM Crown Glass Ceramic	/	FDA UDI	N	Active
CAD/CAM Pontic Resin	/	FDA UDI	N	Active
CAD/CAM Inlay Co Cr	/	FDA UDI	N	Active
SLM Frame & Partial Titanium Alloy	/	FDA UDI	N	Active
CAD/CAM Fused Resin Crown Co Cr	/	FDA UDI	N	Active
CAD/CAM Post & Core Zirconia	/	FDA UDI	N	Active
Cast Framne & Partial Denture Pure Titanium	/	FDA UDI	Class I	Active
CAD/CAM Post & Core Glass Ceramic	/	FDA UDI	N	Active
CAD/CAM PFM Pontic Co Cr	/	FDA UDI	N	Active
Fused Resin Pontic Co Cr	/	FDA UDI	N	Active
CAD/CAM Crown Pure Titanium	/	FDA UDI	Class I	Active
CAD/CAM Inlay Titanium Alloy	/	FDA UDI	N	Active
CAD/CAM Pontic PEEK	/	FDA UDI	N	Active

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