CERAROOT IMPLANT SYSTEM

Implant, Endosseous, Root-form

ORAL ICEBERG S.L.

The following data is part of a premarket notification filed by Oral Iceberg S.l. with the FDA for Ceraroot Implant System.

Pre-market Notification Details

• Device ID: K093595
• 510k Number: K093595
• Device Name: CERAROOT IMPLANT SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: ORAL ICEBERG S.L. 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746
• Contact: Stuart R Goldman
• Correspondent: Stuart R Goldman; ORAL ICEBERG S.L. 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: 2009-11-19
• Decision Date: 2011-01-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08435453900737	K093595	000
08435453900423	K093595	000
08435453900430	K093595	000
08435453900447	K093595	000
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08435453900492	K093595	000
08435453900508	K093595	000
08435453900515	K093595	000
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08435453900539	K093595	000
08435453900546	K093595	000
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08435453900416	K093595	000
08435453900409	K093595	000
08435453900256	K093595	000
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08435453900065	K093595	000
08435453900072	K093595	000
08435453900249	K093595	000