SNAPSHOT

System, X-ray, Extraoral Source, Digital

INSTRUMENTARIUM DENTAL, PALODEX GROUP OY

The following data is part of a premarket notification filed by Instrumentarium Dental, Palodex Group Oy with the FDA for Snapshot.

Pre-market Notification Details

• Device ID: K081925
• 510k Number: K081925
• Device Name: SNAPSHOT
• Classification: System, X-ray, Extraoral Source, Digital
• Applicant: INSTRUMENTARIUM DENTAL, PALODEX GROUP OY NAHKELANTIE 160 Tuusula, Finland, FI 04300
• Contact: Jouni Onnela
• Correspondent: Jouni Onnela; INSTRUMENTARIUM DENTAL, PALODEX GROUP OY NAHKELANTIE 160 Tuusula, Finland, FI 04300
• Product Code: MUH
• CFR Regulation Number: 872.1800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-07-07
• Decision Date: 2008-09-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06430035872527	K081925	000
06430035872510	K081925	000