FDA-Device2020-02-12Class II

Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.

Jjgc Industria E Comercio De Materials Dentarios Sa
Hazard

The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill".

Sold states
Distributed to consignees in CA and PA.
Affected count
2
Manufactured in
Av Juscelino Kubitschek De Oliveira, N/A, Curitiba, N/A, Brazil
Products
Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0924-2020

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