ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM

Implant, Endosseous, Root-form

ACE SURGICAL SUPPLY COMPANY INC.

The following data is part of a premarket notification filed by Ace Surgical Supply Company Inc. with the FDA for Ace Freedom Internal Hexagon Dental Implant System.

Pre-market Notification Details

• Device ID: K102981
• 510k Number: K102981
• Device Name: ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: ACE SURGICAL SUPPLY COMPANY INC. 1034 PEARL ST. Brockton, MA 02401
• Contact: Carol A Houts
• Correspondent: Carol A Houts; ACE SURGICAL SUPPLY COMPANY INC. 1034 PEARL ST. Brockton, MA 02401
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-10-07
• Decision Date: 2010-12-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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