ET IV SA Dental Implants

Implant, Endosseous, Root-form

Hiossen, Inc.

The following data is part of a premarket notification filed by Hiossen, Inc. with the FDA for Et Iv Sa Dental Implants.

Pre-market Notification Details

• Device ID: K183242
• 510k Number: K183242
• Device Name: ET IV SA Dental Implants
• Classification: Implant, Endosseous, Root-form
• Applicant: Hiossen, Inc. 85 Ben Fairless Drive Fairless Hills, PA 19030
• Contact: Peter Lee
• Correspondent: Peter Lee; Hiossen, Inc. 85 Ben Fairless Drive Fairless Hills, PA 19030
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-11-21
• Decision Date: 2019-05-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00814913028866	K183242	000
00814913029009	K183242	000
00814913029016	K183242	000
00814913029023	K183242	000
00814913029030	K183242	000
00814913029047	K183242	000
00814913029054	K183242	000
00814913029061	K183242	000
00814913029078	K183242	000
00814913029085	K183242	000
00814913029092	K183242	000
00814913028996	K183242	000
00814913028989	K183242	000
00814913028972	K183242	000
00814913028873	K183242	000
00814913028880	K183242	000
00814913028897	K183242	000
00814913028903	K183242	000
00814913028910	K183242	000
00814913028927	K183242	000
00814913028934	K183242	000
00814913028941	K183242	000
00814913028958	K183242	000
00814913028965	K183242	000
00814913029108	K183242	000
00814913029115	K183242	000
00814913029252	K183242	000
00814913029269	K183242	000
00814913029276	K183242	000
00814913029283	K183242	000
00814913029290	K183242	000
00814913029306	K183242	000
00814913029313	K183242	000
00814913029320	K183242	000
00814913029337	K183242	000
00814913029344	K183242	000
00814913029245	K183242	000
00814913029238	K183242	000
00814913029221	K183242	000
00814913029122	K183242	000
00814913029139	K183242	000
00814913029146	K183242	000
00814913029153	K183242	000
00814913029160	K183242	000
00814913029177	K183242	000
00814913029184	K183242	000
00814913029191	K183242	000
00814913029207	K183242	000
00814913029214	K183242	000
00814913029351	K183242	000