DEEP BLUE

Activator, Ultraviolet, For Polymerization

E.M.S. ELECTRO MEDICAL SYSTEMS S.A.

The following data is part of a premarket notification filed by E.m.s. Electro Medical Systems S.a. with the FDA for Deep Blue.

Pre-market Notification Details

• Device ID: K071722
• 510k Number: K071722
• Device Name: DEEP BLUE
• Classification: Activator, Ultraviolet, For Polymerization
• Applicant: E.M.S. ELECTRO MEDICAL SYSTEMS S.A. 49 PLAIN STREET North Attleboro, MA 02760
• Contact: Cynthia J.m. Nolte
• Correspondent: Cynthia J.m. Nolte; E.M.S. ELECTRO MEDICAL SYSTEMS S.A. 49 PLAIN STREET North Attleboro, MA 02760
• Product Code: EBZ
• CFR Regulation Number: 872.6070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-06-22
• Decision Date: 2007-08-10
• Summary: summary