BIOPLANT

Bone Grafting Material, Synthetic

KERR DENTAL MATERIALS CENTER

The following data is part of a premarket notification filed by Kerr Dental Materials Center with the FDA for Bioplant.

Pre-market Notification Details

• Device ID: K050984
• 510k Number: K050984
• Device Name: BIOPLANT
• Classification: Bone Grafting Material, Synthetic
• Applicant: KERR DENTAL MATERIALS CENTER 1717 WEST COLLINS AVE. Orange, CA 92867
• Contact: Colleen Boswell
• Correspondent: Colleen Boswell; KERR DENTAL MATERIALS CENTER 1717 WEST COLLINS AVE. Orange, CA 92867
• Product Code: LYC
• CFR Regulation Number: 872.3930 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-04-19
• Decision Date: 2005-08-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841396100048	K050984	000
00841396100031	K050984	000
00841396100024	K050984	000
00841396100017	K050984	000
00841396100000	K050984	000