Splintline Powder

FDA UDI

Class II (US FDA UDI)

by Lang Dental Manufacturing Company, Inc.

Identity

Trade Name: SPLINTLINE POWDER FDA UDI
Generic Name: Temporary dental crown/bridge resin FDA UDI
Device Name: FAST CURING PROVISIONAL CROWN & BRIDGE ACRYLIC RESIN POWDER FDA UDI
Model / Reference: 11.3 KG SHADE 67/B3 FDA UDI
Description: FAST CURING PROVISIONAL CROWN & BRIDGE ACRYLIC RESIN POWDER FDA UDI

Identifiers

Catalog Number: 207067TS FDA UDI
Primary DI / UDI-DI: D650207067TS0 FDA UDI
FDA Product Code: EBG FDA UDI
GMDN Term: Temporary dental crown/bridge resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3770 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Temporary dental crown/bridge resin

Splintline Powder by Lang Dental Manufacturing Company, Inc. — 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: Lang Dental Manufacturing Company, Inc.

Sources (1)

FDA UDI ba1626ff-deeb-4d32-889a-5bdb7a00a3fe 34 fields · synced May 31, 2026