Spirit

Unit, Operative Dental

PELTON & CRANE

The following data is part of a premarket notification filed by Pelton & Crane with the FDA for Spirit.

Pre-market Notification Details

• Device ID: K143696
• 510k Number: K143696
• Device Name: Spirit
• Classification: Unit, Operative Dental
• Applicant: PELTON & CRANE 11727 FRUEHAUF DR. Charlotte, NC 28273
• Contact: Frank Ray
• Correspondent: Frank Ray; PELTON & CRANE 11727 FRUEHAUF DR. Charlotte, NC 28273
• Product Code: EIA
• CFR Regulation Number: 872.6640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-12-24
• Decision Date: 2015-09-18
• Summary: summary