FDA-Device2019-04-03Class II

Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112

Keystone Dental Inc
Hazard

Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature

Sold states
FL, MA, SC, VA
Affected count
13 kits hex Driver
Manufactured in
154 Middlesex Tpke, N/A, Burlington, MA, United States
Products
Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1061-2019

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