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D-Sign VI (R&D Project DW266#9)

by Ivoclar North America, Inc. 510(k)

Active United States

510(k) K990235

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK990235 Date1 Mar 1999ClearedStatusActive

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  • Withdrawn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
EJH
Device Class
Class II
Regulation
21 CFR Part 872.3710
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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