CHIROPRO L SYSTEM— 510(k) K092214

Substantially Equivalent

Bien-Air Dental, SA

FDA 510(k) clearance K092214 for CHIROPRO L SYSTEM, Substantially Equivalent on 2009-12-15. Applicant: Bien-Air Dental, SA. Device class: 1.

Clearance details

Applicant: Bien-Air Dental, SA
Product code: Code EBW
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2009-07-22
Decision date: 2009-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K092214

K-number listed on FDA's recall record

Z-0273-2014 — Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.Class II·Terminated·Nobel Biocare Usa Llc·20131024

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092214.

Data sourced from openFDA. This site is unofficial and independent of the FDA.