BISICO Dispenser 25

FDA UDI

Class I (US FDA UDI)

by bisico Bielefelder Dentalsilicone GmbH & Co. KG

Identity

Trade Name: BISICO Dispenser 25 FDA UDI
Generic Name: Dental impression material syringe, reusable FDA UDI
Device Name: A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient's mouth. FDA UDI
Model / Reference: 01940 FDA UDI
Description: A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient's mouth. FDA UDI

Identifiers

Catalog Number: 01940 FDA UDI
Primary DI / UDI-DI: EBIB019401 FDA UDI
FDA Product Code: EID FDA UDI
GMDN Term: Dental impression material syringe, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental impression material syringe, reusable

BISICO Dispenser 25 by bisico Bielefelder Dentalsilicone GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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MASTER-DENT — DENTONICS, INC.

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 I	Pending data

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Manufacturer

Manufacturer: bisico Bielefelder Dentalsilicone GmbH & Co. KG

Sources (1)

FDA UDI 41935124-5b28-442b-9fa8-418f6c8c24e9 35 fields · synced May 30, 2026