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Duraflex DF-PNC-MD-6PK

by The Myerson Company Limited

Listed FDA GUDID listing, no authorization on record

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 Number00842326128118 UDI-DI Date26 May 2026ListedStatusListed GUDID: 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  • Withdrawn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

Trade Name
Duraflex
Generic Name
Dental appliance fabrication material, thermoplastic
Model / Reference
DF-PNC-MD-6PK
Primary DI / UDI-DI
00842326128118
510(k) Number
FDA Product Code
EBI
GMDN Term
Dental appliance fabrication material, thermoplastic
Device Class
Class II
Regulation Number
872.3760
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K063626)

Other devices from The Myerson Company Limited

See all devices from The Myerson Company Limited →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No