← Back to catalogue

Restoration

FDA UDI

Class N (US FDA UDI)

by Modern Dental Laboratory (DG) Co., Ltd.

Identity

Trade Name
Restoration FDA UDI
Generic Name
Custom-made dental crown, metal/ceramic FDA UDI
Model / Reference
104 FDA UDI

Identifiers

Primary DI / UDI-DI
06972677871044 FDA UDI
FDA Product Code
NSJ FDA UDI
NSO FDA UDI
GMDN Term
Custom-made dental crown, metal/ceramic FDA UDI

Classification

Device Class
N FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental casting noble alloyDental bridge, metal-ceramicCustom-made dental crown, metal/ceramicCustom-made dental crown, metal

Restoration by Modern Dental Laboratory (DG) Co., Ltd. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gold dental inlay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Modern Dental Laboratory (DG) Co., Ltd.

Sources (1)

  • FDA UDI 3b2445ae-0025-4a10-be78-e15ca36e4d6b 32 fields · synced Jun 7, 2026