S-MINI IMPLANT SYSTEM

Implant, Endosseous, Root-form

NEOBIOTECH CO., LTD.

The following data is part of a premarket notification filed by Neobiotech Co., Ltd. with the FDA for S-mini Implant System.

Pre-market Notification Details

• Device ID: K112540
• 510k Number: K112540
• Device Name: S-MINI IMPLANT SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: NEOBIOTECH CO., LTD. 325 N PUENTE ST. UNIT B Brea, CA 92821
• Contact: April Lee
• Correspondent: April Lee; NEOBIOTECH CO., LTD. 325 N PUENTE ST. UNIT B Brea, CA 92821
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-09-01
• Decision Date: 2012-02-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08809276761439	K112540	000
08809407155694	K112540	000
08809407155700	K112540	000
08809407155717	K112540	000
08809407155724	K112540	000
08809407155731	K112540	000
08809407155748	K112540	000
08809407155755	K112540	000
08809407155762	K112540	000
08809407155779	K112540	000
08809407155786	K112540	000
08809407155793	K112540	000
08809407155809	K112540	000
08809407155816	K112540	000
08809407155687	K112540	000
08809407155670	K112540	000
08809407155540	K112540	000
08809407155557	K112540	000
08809407155564	K112540	000
08809407155571	K112540	000
08809407155588	K112540	000
08809407155595	K112540	000
08809407155601	K112540	000
08809407155618	K112540	000
08809407155625	K112540	000
08809407155632	K112540	000
08809407155649	K112540	000
08809407155656	K112540	000
08809407155663	K112540	000
08809407155823	K112540	000
08809407155830	K112540	000
08809407157117	K112540	000
08809407157124	K112540	000
08809407157131	K112540	000
08809407157148	K112540	000
08809407157155	K112540	000
08809407157162	K112540	000
08809407157179	K112540	000
08809407157186	K112540	000
08809407157193	K112540	000
08809407157209	K112540	000
08809407157216	K112540	000
08809407157223	K112540	000
08809407157230	K112540	000
08809407157100	K112540	000
08809407157094	K112540	000
08809407155847	K112540	000
08809407155854	K112540	000
08809407156967	K112540	000
08809407156974	K112540	000
08809407156981	K112540	000
08809407156998	K112540	000
08809407157001	K112540	000
08809407157018	K112540	000
08809407157025	K112540	000
08809407157032	K112540	000
08809407157049	K112540	000
08809407157070	K112540	000
08809407157087	K112540	000
08809407157056	K112540	000