BIO-SCREEN

Diagnostic Light, Soft Tissue Detector

ADDENT, INC.

The following data is part of a premarket notification filed by Addent, Inc. with the FDA for Bio-screen.

Pre-market Notification Details

• Device ID: K082668
• 510k Number: K082668
• Device Name: BIO-SCREEN
• Classification: Diagnostic Light, Soft Tissue Detector
• Applicant: ADDENT, INC. 43 MIRY BROOK RD. Danbury, CT 06810
• Contact: Joshua Friedman
• Correspondent: Joshua Friedman; ADDENT, INC. 43 MIRY BROOK RD. Danbury, CT 06810
• Product Code: NXV
• CFR Regulation Number: 872.6350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-09-12
• Decision Date: 2009-01-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D813PLS10010	K082668	000
D813PLS10030	K082668	000