PROSOFT

Reliner, Denture, Over The Counter

PERMA LABORATORIES

The following data is part of a premarket notification filed by Perma Laboratories with the FDA for Prosoft.

Pre-market Notification Details

• Device ID: K121318
• 510k Number: K121318
• Device Name: PROSOFT
• Classification: Reliner, Denture, Over The Counter
• Applicant: PERMA LABORATORIES 120 Wakefield Run Blvd Hinckley, OH 44233
• Correspondent: Mark Job; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: EBP
• CFR Regulation Number: 872.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2012-05-02
• Decision Date: 2012-06-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00852305002018	K121318	000