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Solventum™ Paradigm™ 5514S

by Solventum US LLC

Solventum™ Paradigm™ 5514S is a Class II device made by Solventum US LLC, listed in FDA GUDID since 24 Oct 2026 (UDI-DI 00197998040733), registry data as of 9 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 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00197998040733 UDI-DI Date24 Oct 2026ListedStatusListed 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  • Withdrawn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
Solventum™ Paradigm™
Generic name
Silicone dental impression material
Model / Ref / Catalog
5514S
Primary DI / UDI-DI
00197998040733
FDA product code
ELW
GMDN term
Silicone dental impression material
Device class
Class II
Regulation number
872.3660
GUDID distribution status
In Commercial Distribution

Other devices from Solventum US LLC

See all devices from Solventum US LLC →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)