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DenMat Multilayered Zirconia Disc

by Denmat Holding, LLC 510(k)

Active United States

510(k) K251593

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK251593 Date25 Aug 2025ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
EIH
Device Class
Class II
Regulation
21 CFR Part 872.6660
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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