Newton Implant Systems, Inc.

FDA Regulatory Profile

Newton Implant Systems, Inc. appears in FDA public data with 0 recalls, 2 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent FDA inspection ended on Aug 18, 2025 (Voluntary Action Indicated (VAI)). Its most recent 510(k) clearance was granted on Apr 11, 2024.

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Summary

Total Recalls
0
510(k) Clearances
2
Inspections
2
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 18, 2025Vista, CABiologicsVoluntary Action Indicated (VAI)3016784205
Jul 19, 2022Vista, CABiologicsVoluntary Action Indicated (VAI)3016784205

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K221847Ni2 Implant SystemApr 11, 2024
K221866S-Plant Dental Implant SystemJan 18, 2024