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IPR Lamineer Tips

Dentatus AB · Model LTA-P/SK2 · UDI-DI 07350081495640

EGS
10
510(k) clearances
2,636
Adverse events
2
Recalls
91
Facilities

Description

5x Assorted Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 1 of each of the following: 0.1mm Blade Thickness, Double Sided 15 Micron Diamond Coating 0.2mm Blade Thickness, Double Sided 40 Micron Diamond Coating 0.3mm Blade Thickness, Double Sided 50 Micron Diamond Coating 0.4mm Blade Thickness, Double Sided 50 Micron Diamond Coating 0.5mm Blade Thickness, Double Sided 50 Micron Diamond Coating

Recalls

DateFirmReason
2023-10-06Young Dental Manufacturing I, LLCone lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs.
2015-08-27Bien Air Dental SAPossible loosening of the dental tool, which may lead to potential swallowing of the tool.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.