Pink EF Series, Splint

FDA UDI

Class II (US FDA UDI)

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

Identity

Trade Name: Pink EF Series,Splint FDA UDI
Generic Name: Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Model / Reference: 184 FDA UDI

Identifiers

Primary DI / UDI-DI: 06972677871846 FDA UDI
FDA Product Code: LRK FDA UDI
NSR FDA UDI
GMDN Term: Mandible-repositioning sleep-disordered breathing orthosis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.5570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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: Mandible-repositioning sleep-disordered breathing orthosis Removable dental occlusal splint, preformed

Pink EF Series, Splint by Modern Dental Laboratory (DG) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 II	Pending data

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Manufacturer

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

Sources (1)

FDA UDI ebd98002-10d6-4c83-8aed-7a9f9ef4ad75 32 fields · synced May 30, 2026