Restoration

FDA UDI

Class N (US FDA UDI)

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

Identity

Trade Name: Restoration FDA UDI
Generic Name: Dental bridge, metal-ceramic FDA UDI
Device Name: Porecelain-fused-to-metal restorations are porcelain-fused-to-metal crown and bridge restorations that are manufactured as finished products from porcelain and noble or base metal alloys. FDA UDI
Model / Reference: 004 FDA UDI
Description: Porecelain-fused-to-metal restorations are porcelain-fused-to-metal crown and bridge restorations that are manufactured as finished products from porcelain and noble or base metal alloys. FDA UDI

Identifiers

Primary DI / UDI-DI: 06972677870047 FDA UDI
FDA Product Code: NSO FDA UDI
GMDN Term: Dental bridge, metal-ceramic FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental bridge, metal-ceramic Custom-made dental crown, metal/ceramic

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 Custom-made dental crown, metal/ceramic.

neo.lign A tooth — bredent GmbH & Co. KG · Class II
neo.lign P tooth — bredent GmbH & Co. KG · Class II
neo.lign A tooth — bredent GmbH & Co. KG · Class II
novo.lign P veneer — bredent GmbH & Co. KG · Class II
neo.lign P tooth — bredent GmbH & Co. KG · Class II
novo.lign P veneer — bredent GmbH & Co. KG · Class II
neo.lign P tooth — bredent GmbH & Co. KG · Class II
Denture, Restoration — ACESO DENTAL LABORATORY COMPANY LIMITED · N

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class N	Pending data

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

Manufacturer

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

Sources (1)

FDA UDI 4302bff1-dd49-4974-91c3-9c6f3102b472 33 fields · synced May 29, 2026