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Cross Linked 2 CL.34A2

by POLIDENT d.o.o. 2 variants

Listed FDA GUDID listing, not in commercial distribution

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberEPOLCL34A2 UDI-DI Date10 Jun 2021ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Cross Linked 2
Generic name
Partial denture
Model / Ref / Catalog
CL.34A2
Primary DI / UDI-DI
EPOLCL34A2
FDA product code
ELM
GMDN term
Partial denture
Device class
Class II
Regulation number
872.3590
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Dry Heat Sterilization
MRI safety
MR Safe
Size
Outer Diameter — 3 Meter

Other devices from POLIDENT d.o.o.

See all devices from POLIDENT d.o.o. →

Properties

  • Sterilise before use
  • Premarket exempt

Other properties (13)

  • Supplied sterile: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Lot / batch number: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No