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M-Pm-Disc

by Merz Dental GmbH

510(k) K134015

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberD7091019080 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK134015 Date11 Apr 2014ClearedStatusActive

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  • Withdrawn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 — FDA 510(k) Active

Specification

510(k) · GUDID

Generic Name
Dental appliance fabrication material, thermoplastic
Model / Ref / Catalog
M-PM Disc, PMMA-Disc, shade clear thickness 16mm, diameter 98, 5mm, 1019080
Primary DI / UDI-DI
D7091019080
510(k) Number
FDA Product Code
MQC
GMDN Term
Dental appliance fabrication material, thermoplastic
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 98.5 Millimeter
Height — 16 Millimeter

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