EdgePro

Laser, Dental, Soft Tissue

Biolase Inc.

The following data is part of a premarket notification filed by Biolase Inc. with the FDA for Edgepro.

Pre-market Notification Details

• Device ID: K213428
• 510k Number: K213428
• Device Name: EdgePro
• Classification: Laser, Dental, Soft Tissue
• Applicant: Biolase Inc. 27042 Towne Centre Drive, Suite 270 Foothill Ranch, CA 92610
• Contact: Ed Balcos
• Correspondent: Ed Balcos; Biolase Inc. 27042 Towne Centre Drive, Suite 270 Foothill Ranch, CA 92610
• Product Code: NVK
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-10-21
• Decision Date: 2021-12-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00647529004296	K213428	000
00818365026623	K213428	000
00818365026609	K213428	000
00818365026593	K213428	000
00818365026586	K213428	000
00818365026579	K213428	000
00818365026562	K213428	000
10818365026552	K213428	000
00818365026548	K213428	000
00818365026524	K213428	000
00818365026517	K213428	000
00818365026500	K213428	000
00818365026494	K213428	000
00818365026470	K213428	000
00818365026463	K213428	000
00818365026630	K213428	000
00818365026647	K213428	000
00818365026654	K213428	000
00647529004241	K213428	000
00647529004135	K213428	000
00647529004326	K213428	000
00647529003572	K213428	000
00647529004180	K213428	000
00647529003589	K213428	000
00647529004319	K213428	000
00818365026722	K213428	000
10818365026712	K213428	000
10818365026705	K213428	000
10818365026699	K213428	000
10818365026682	K213428	000
10818365026675	K213428	000
10818365026668	K213428	000
10818365026453	K213428	000