Implant Direct Sybron Manufacturing, LLC

Lot Number: 79607

Dental Devices

2

Yes

Worldwide distribution: US (nationwide) including Puerto Rico and country of Japan.

ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 || This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

Parts Numbers: DGDE, SPCST, IBST, BST, CST, ICST, IBST, RBST, RCST   Lot Number: 61928, 64895, 64898, 64896, 65406, 65405, 65407, 65408, 65410, 65409, 65357, 67055, 67475, 67345, 37475, 67476, 67474, 67478, 67477, 67479, 67527, 68254, 68266, 68253, 68265, 68262

Dental Devices

2

Yes

Worldwide Distribution- US (nationwide) including the states of CA, FL, TX, MO, MI, MA, NV, OR, PA, AZ, IL, VA, OH, GA, and SC, and the country of Canada, Poland, Serbia, Italy, Germany, Cairo, Jordan, El Salvador, Kuwait, Costa Rica, Switzerland, Colombia, United Kingdom, Austria, Netherlands, Chile, and Egypt.

DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be inserted and locked in place.

Lot #71729

Dental Devices

2

Yes

Distribution was made to FL, GA, MD, MI, NC, NY, OR, TX, UT and VA. There was no foreign/military/government distribution.

ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.

Part No. (Lot No.): 924108 (97347), 924112 (64927, 93563, 98662), 924116 (70543), 924806 (99749), 924810W (93934), 924812W (94204), and 924814 (103199).

Dental Devices

2

Yes

Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.

SwishPlus Implant || Intended for use in support for fixed bridgework.

Part No. (Lot No.): 934106 (68075, 69252, 79574), 934112 (69101, 80912), 934806 (68076, 75219), 934812 (68078, 68889), 934814 (67980), and 935712 (68077).

Dental Devices

2

Yes

Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.

SwishTapered Implant || Intended for use in support for fixed bridgework.