HC-BIOS DENTAL IMPLANT

Implant, Endosseous, Root-form

HUNG CHUN BIO-S CO., LTD.

The following data is part of a premarket notification filed by Hung Chun Bio-s Co., Ltd. with the FDA for Hc-bios Dental Implant.

Pre-market Notification Details

• Device ID: K110425
• 510k Number: K110425
• Device Name: HC-BIOS DENTAL IMPLANT
• Classification: Implant, Endosseous, Root-form
• Applicant: HUNG CHUN BIO-S CO., LTD. NO.45, MINSHENG RD DANSHUI TOWN Taipei County, TW 251
• Contact: Michael Lee
• Correspondent: Michael Lee; HUNG CHUN BIO-S CO., LTD. NO.45, MINSHENG RD DANSHUI TOWN Taipei County, TW 251
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-02-14
• Decision Date: 2012-07-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04719871590607	K110425	000
04719871590430	K110425	000
04719871590423	K110425	000
04719871590409	K110425	000
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04719871590065	K110425	000
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04719871590232	K110425	000
04719871590225	K110425	000
04719871590218	K110425	000
04719871590201	K110425	000
04719871590195	K110425	000
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04719871590751	K110425	000
04719871590614	K110425	000