OSSEOLINK DENTAL IMPLANT SYSTEM

Implant, Endosseous, Root-form

GLOBAL IMPLANT SOLUTIONS, LLC

The following data is part of a premarket notification filed by Global Implant Solutions, Llc with the FDA for Osseolink Dental Implant System.

Pre-market Notification Details

• Device ID: K091878
• 510k Number: K091878
• Device Name: OSSEOLINK DENTAL IMPLANT SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: GLOBAL IMPLANT SOLUTIONS, LLC 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746
• Contact: Stuart R Goldman
• Correspondent: Stuart R Goldman; GLOBAL IMPLANT SOLUTIONS, LLC 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-06-23
• Decision Date: 2009-10-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10816273020006	K091878	000
00816273020221	K091878	000
00816273020238	K091878	000
00816273020245	K091878	000
00816273020252	K091878	000
00816273020269	K091878	000
00816273020276	K091878	000
00816273020283	K091878	000
00816273020290	K091878	000
00816273020306	K091878	000
00816273020313	K091878	000
00816273020320	K091878	000
00816273020337	K091878	000
00816273020344	K091878	000
00816273020351	K091878	000
00816273020368	K091878	000
00816273020375	K091878	000
00816273020214	K091878	000
00816273020207	K091878	000
00816273020191	K091878	000
10816273020013	K091878	000
10816273020020	K091878	000
10816273020044	K091878	000
10816273020051	K091878	000
10816273020068	K091878	000
10816273020082	K091878	000
10816273020099	K091878	000
10816273020105	K091878	000
00816273020115	K091878	000
00816273020122	K091878	000
00816273020139	K091878	000
00816273020146	K091878	000
00816273020153	K091878	000
00816273020160	K091878	000
00816273020177	K091878	000
00816273020184	K091878	000
00816273020382	K091878	000
00816273020399	K091878	000
00816273020597	K091878	000
00816273020603	K091878	000
00816273020610	K091878	000
00816273020627	K091878	000
00816273020634	K091878	000
00816273020641	K091878	000
00816273020658	K091878	000
00816273020665	K091878	000
00816273020672	K091878	000
00816273020689	K091878	000
00816273020696	K091878	000
00816273020702	K091878	000
00816273020719	K091878	000
00816273020726	K091878	000
00816273020733	K091878	000
00816273020740	K091878	000
00816273020580	K091878	000
00816273020573	K091878	000
00816273020566	K091878	000
00816273020405	K091878	000
00816273020412	K091878	000
00816273020429	K091878	000
00816273020436	K091878	000
00816273020443	K091878	000
00816273020450	K091878	000
00816273020467	K091878	000
00816273020474	K091878	000
00816273020481	K091878	000
00816273020498	K091878	000
00816273020504	K091878	000
00816273020511	K091878	000
00816273020528	K091878	000
00816273020535	K091878	000
00816273020542	K091878	000
00816273020559	K091878	000
00816273020757	K091878	000