HEXLOCK

Implant, Endosseous, Root-form

IMTEC CORP.

The following data is part of a premarket notification filed by Imtec Corp. with the FDA for Hexlock.

Pre-market Notification Details

• Device ID: K912262
• 510k Number: K912262
• Device Name: HEXLOCK
• Classification: Implant, Endosseous, Root-form
• Applicant: IMTEC CORP. 5 "A" ST., N.W. - SUITE 2 Ardmore, OK 73401
• Contact: Gillespie
• Correspondent: Gillespie; IMTEC CORP. 5 "A" ST., N.W. - SUITE 2 Ardmore, OK 73401
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-05-22
• Decision Date: 1991-12-10