PROTEMP

Crown And Bridge, Temporary, Resin

ESPE GMBH (US)

The following data is part of a premarket notification filed by Espe Gmbh (us) with the FDA for Protemp.

Pre-market Notification Details

• Device ID: K822452
• 510k Number: K822452
• Device Name: PROTEMP
• Classification: Crown And Bridge, Temporary, Resin
• Applicant: ESPE GMBH (US) 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: EBG
• CFR Regulation Number: 872.3770 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-08-16
• Decision Date: 1982-09-28