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PMMA CAD/CAM Disc PMMA.564

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 NumberEPOLPMMA564 UDI-DI Date14 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  • Withdrawn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
PMMA CAD/CAM Disc
Generic Name
Custom-made dental crown, polymer
Model / Ref / Catalog
PMMA.564
Primary DI / UDI-DI
EPOLPMMA564
FDA Product Code
EBG
GMDN Term
Custom-made dental crown, polymer
Device Class
Class II
Regulation Number
872.3770
GUDID distribution status
Not in Commercial Distribution
Sterilization 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

Other properties (14)

  • 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
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No