Polysil Multipurpose Regular Set

FDA UDI

Class II (US FDA UDI)

by Scican GmbH

Identity

Trade Name: Polysil Multipurpose Regular Set FDA UDI
Generic Name: Silicone dental impression material FDA UDI
Device Name: Dental impression material to reproduce the structure of a patient's teeth and gums. Packaged in a cartridge system. Monophase, regular set. FDA UDI
Model / Reference: SH-104 FDA UDI
Description: Dental impression material to reproduce the structure of a patient's teeth and gums. Packaged in a cartridge system. Monophase, regular set. FDA UDI

Identifiers

Catalog Number: SH-104 FDA UDI
Primary DI / UDI-DI: 07540196000543 FDA UDI
FDA Product Code: ELW FDA UDI
GMDN Term: Silicone dental impression material FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3660 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

FDA UDI

Category: Silicone dental impression material

Polysil Multipurpose Regular Set by Scican GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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PERFECTO — CROWN DELTA CORP. · Class II
Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · Class I
Counter-FIT™ Quick 36pk — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · 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: Scican GmbH

Sources (1)

FDA UDI ad4587cb-388b-4258-a0b9-c754c670fe10 36 fields · synced May 29, 2026