MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM

Implant, Endosseous, Root-form

BLUE SKY BIO, LLC

The following data is part of a premarket notification filed by Blue Sky Bio, Llc with the FDA for Modification To Blue Sky Bio Dental Implant System.

Pre-market Notification Details

• Device ID: K051507
• 510k Number: K051507
• Device Name: MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: BLUE SKY BIO, LLC 888 E BELVIDERE RD. SUITE 212 Grayslake, IL 60030
• Contact: Albert Zickmann
• Correspondent: Albert Zickmann; BLUE SKY BIO, LLC 888 E BELVIDERE RD. SUITE 212 Grayslake, IL 60030
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-06-07
• Decision Date: 2005-09-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00815131021431	K051507	000
00815131021585	K051507	000
00815131021592	K051507	000
00815131021608	K051507	000
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00815131021660	K051507	000
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00815131021455	K051507	000
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00815131021714	K051507	000
00815131022216	K051507	000
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00815131022209	K051507	000
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