Polysil Heavy Viscosity Regular Set SH-103

Polysil Heavy Viscosity Regular Set SH-103 is a Class II device made by Scican Ltd, listed in FDA GUDID since 2 Aug 2016 (UDI-DI 07540196000529), registry data as of 12 Nov 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number07540196000529 UDI-DI	Date2 Aug 2016Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 07540196000529

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Polysil Heavy Viscosity Regular Set
Generic name: Silicone dental impression material
Model / Ref / Catalog: SH-103

Primary DI / UDI-DI: 07540196000529
FDA product code: ELW
GMDN term: Silicone dental impression material

Device class: Class II
Regulation number: 872.3660
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Lot / batch number
Expiration date

Other properties (12, all answered No)