FDA-Device2018-05-02Class II

Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket

Keystone Dental Inc
Hazard

The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette.

Sold states
USA (nationwide) Distribution and Internationally to Turkey.
Affected count
19
Manufactured in
154 Middlesex Tpke, N/A, Burlington, MA, United States
Products
Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1485-2018

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