BTI DENTAL IMPLANT TINY 2.5-3.0

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 Bti Dental Implant Tiny 2.5-3.0.

Pre-market Notification Details

• Device ID: K092112
• 510k Number: K092112
• Device Name: BTI DENTAL IMPLANT TINY 2.5-3.0
• Classification: Implant, Endosseous, Root-form
• Applicant: B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. LEONARDO DA VINCI 14 B Minano(alava), ES 01510
• Contact: Alfredo Gomez
• Correspondent: Alfredo Gomez; B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. LEONARDO DA VINCI 14 B Minano(alava), ES 01510
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-07-14
• Decision Date: 2009-10-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08435389818793	K092112	000
08435389803485	K092112	000
08435389803492	K092112	000
08435389803515	K092112	000
08435389803539	K092112	000
08435389803560	K092112	000
08435389809494	K092112	000
08435389810735	K092112	000
08435389811244	K092112	000
08435389818786	K092112	000
08435389803478	K092112	000