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IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT - Ob-Xx

by Imtec Corp.

510(k) K031106

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK031106 Date12 Aug 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1703-2010 FDA Unclassified (pre-2012) initiated 14 May 2010

    Product has Incorrect size Labeling. Actual length is 13mm. One label is correct, and one states 10mm.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DZE
Models / Variants
Ob-Xx
Device Class
Class II
Regulation
21 CFR Part 872.3640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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