Implant Innovations, Inc.

lot numbers 127726 and 191427

Dental Devices

2

Yes

Nationwide & France, Japan, Spain, Germany, Korea, Australia, Argentina, Denmark, Chile, England, Brazil.

Products are surgical drills packaged separately or included in a surgical kit so two products will be listed. || The second product is the 8mm drill included in a kit and It is labeled as OFKIT2 OsseoFix System Complete (Kit)3i Implant Innovations, Inc. 4555 Riverside drive, Palm Beach Gardens, FL 33410 Non Sterile Contents must be sterilized prior to use. RX only.

lot numbers 126509, 183758, 186315, 188528, 187918, 188867, 190033, 191429, 196769.

Dental Devices

2

Yes

Nationwide & France, Japan, Spain, Germany, Korea, Australia, Argentina, Denmark, Chile, England, Brazil.

Product is a drill used in dental surgery labeled in part: OFDR8 OsseoFix Drill 8mm Length 3i Implant Innovations, Inc. 4555 Riverside drive, Palm Beach Gardens, FL 33410 Non Sterile Contents must be sterilized prior to use. RX only.

For LTX 611 lot number 150102P For LTX 515 lot number 150100P

Dental Devices

2

Yes

Product was distributed to four international distributor accounts only in Brasil, Korea, Taiwan and Chile.

LTX Endosseous Implant 6.0 mm X 11.5 mm and also LTX Endosseous Implant 5.0 mm X 15 mm, Sterile,