TheraCal LC

FDA UDI

Class II (US FDA UDI)

by Bisco Inc.

Identity

Trade Name: TheraCal LC FDA UDI
Generic Name: Dental composite resin FDA UDI
Device Name: TheraCal LC 1g Syringe Pkg FDA UDI
Model / Reference: H-3301P FDA UDI
Description: TheraCal LC 1g Syringe Pkg FDA UDI

Identifiers

Catalog Number: H-3301P FDA UDI
Primary DI / UDI-DI: 00810111540018 FDA UDI
FDA Product Code: EJK FDA UDI
EID FDA UDI
GMDN Term: Dental composite resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3250 FDA UDI
872.4565 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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental composite resin

TheraCal LC by Bisco Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
Llis — Dentscare Ltda · Class II
Capo Universal, 6 g — Schütz Dental GmbH · Class II
OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II

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: Bisco Inc.

Sources (1)

FDA UDI 6dda2ce0-e5d1-4168-b94e-a5310aab8851 36 fields · synced May 31, 2026