B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM

Implant, Endosseous, Root-form

B.T.I. BIOTECHNOLOGY INSTITUTE, S.L.

The following data is part of a premarket notification filed by B.t.i. Biotechnology Institute, S.l. with the FDA for B.t.i. Biotechnology Institute, S.l. Dental Implant System.

Pre-market Notification Details

• Device ID: K022258
• 510k Number: K022258
• Device Name: B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. PARQUE TECNOLOGICO DE ALAVA LEONARDO DA VINCI, 14B 01510 Minano (alava), ES
• Contact: Alfredoco Gomez
• Correspondent: Alfredoco Gomez; B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. PARQUE TECNOLOGICO DE ALAVA LEONARDO DA VINCI, 14B 01510 Minano (alava), ES
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-07-12
• Decision Date: 2003-09-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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