IMPLA-MED IMPLANT SYSTEM

Implant, Endosseous, Root-form

IMPLA-MED

The following data is part of a premarket notification filed by Impla-med with the FDA for Impla-med Implant System.

Pre-market Notification Details

• Device ID: K892124
• 510k Number: K892124
• Device Name: IMPLA-MED IMPLANT SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: IMPLA-MED 13794 N.W. 4TH ST. SUITE 209 Sunrise, FL 33325
• Contact: Bruce L Nickerson
• Correspondent: Bruce L Nickerson; IMPLA-MED 13794 N.W. 4TH ST. SUITE 209 Sunrise, FL 33325
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-04-04
• Decision Date: 1989-10-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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