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Polysil Multipurpose Regular Set SH-104

by Scican Ltd

Polysil Multipurpose Regular Set SH-104 is a Class II device made by Scican Ltd, listed in FDA GUDID since 2 Aug 2016 (UDI-DI 07540196000543), 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

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07540196000543 UDI-DI Date2 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Polysil Multipurpose Regular Set
Generic name
Silicone dental impression material
Model / Ref / Catalog
SH-104
Primary DI / UDI-DI
07540196000543
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)