ETIII SA Fixture System (O3.2mm)

Implant, Endosseous, Root-form

HIOSSEN INC.

The following data is part of a premarket notification filed by Hiossen Inc. with the FDA for Etiii Sa Fixture System (o3.2mm).

Pre-market Notification Details

• Device ID: K153332
• 510k Number: K153332
• Device Name: ETIII SA Fixture System (O3.2mm)
• Classification: Implant, Endosseous, Root-form
• Applicant: HIOSSEN INC. 85 BEN FAIRLESS DR. Fairless Hills, PA 19030
• Contact: Patrick Lim
• Correspondent: David Kim; HIOSSEN INC. 85 BEN FAIRLESS DR. Fairless Hills, PA 19030
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-11-19
• Decision Date: 2016-10-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00814913024486	K153332	000
00814913028859	K153332	000
00814913028842	K153332	000
00814913028835	K153332	000
00814913028828	K153332	000
00814913028811	K153332	000
00814913028804	K153332	000
00814913028798	K153332	000
00814913028781	K153332	000
00814913028774	K153332	000
00814913028767	K153332	000
00810126043269	K153332	000
00810126044303	K153332	000
00810126044280	K153332	000
00810126044266	K153332	000
00810126044242	K153332	000
00810126044228	K153332	000
00814913020518	K153332	000
00814913020525	K153332	000
00814913020532	K153332	000
00814913024479	K153332	000
00814913024462	K153332	000
00814913024455	K153332	000
00814913024448	K153332	000
00814913024431	K153332	000
00814913024424	K153332	000
00814913024417	K153332	000
00814913024400	K153332	000
00814913024394	K153332	000
00814913024387	K153332	000
00814913024370	K153332	000
00814913024363	K153332	000
00814913024356	K153332	000
00814913024349	K153332	000
00814913020556	K153332	000
00814913020549	K153332	000
00810126043245	K153332	000