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M-PM Disc

by Merz Dental GmbH 9 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD7091019083 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Removable dental occlusal splint, custom-made
Model / Ref / Catalog
M-PM Disc, PMMA-Disc, shade clear thickness 20mm, diameter 100mm, 1019083
Primary DI / UDI-DI
D7091019083
510(k) Number
FDA Product Code
MQC
GMDN Term
Removable dental occlusal splint, custom-made
Device Class
U
GUDID distribution status
Not in Commercial Distribution
Size
Outer Diameter — 100 Millimeter
Height — 20 Millimeter

Related devices

Cleared under the same submission (K134015)

Show all (10)

Other devices from Merz Dental GmbH

See all devices from Merz Dental GmbH →

Properties

  • Lot / Batch Number
  • Expiration Date

Other properties (12)

  • 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
  • Serial Number: No
  • Manufacturing Date: No