One and Two Piece Temporary Healing, (Emergence Profile) Abutments

510(k) K934126

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

7 closed

Documents

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK934126	Date25 Apr 1994Cleared	StatusActive

7 recalls · FDA

- Terminated Z-2441-2016 FDA Class II initiated 25 Nov 2015
Pouches may not have been sealed during packing.
2 recalls, same reason
- Terminated Z-0591-2016 FDA Class II initiated 21 Sep 2015
- Terminated Z-0592-2016 FDA Class II initiated 21 Sep 2015
Inadequate biocompatibility testing.
- Terminated Z-2799-2011 FDA Unclassified (pre-2012) initiated 23 Feb 2010 on shared 510(k) K934126
Biomet 3i of Palm Beach Gardens, FL is recalling their Certain EP Healing Abutment (IWTH56). The Healing Abutment dimensions did not match outside label and laser etching on part. The product was actually 8mm but the package indicated 6mm.
- Terminated Z-0811-2007 FDA Unclassified (pre-2012) initiated 25 Apr 2007
The Straight Healing Abutment did not fully seat to the restorative platform of the implant, leaving a gap between the abutment and the implant.
- Terminated Z-0922-2007 FDA Unclassified (pre-2012) initiated 16 Oct 2006
Package Integrity; sterility compromised-Incomplete seals on the nylon bags in which the product is packed.
- Terminated Z-0029-05 FDA Unclassified (pre-2012) initiated 4 Oct 2004
The nylon bag holding the product was not completely sealed before sterilization. Patients could be infected if the abutment is implanted.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)