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 Blue Sky Bio Dental Implant System.

Pre-market Notification Details

• Device ID: K073713
• 510k Number: K073713
• Device Name: 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: Michele Vovolka
• Correspondent: Michele Vovolka; 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: 2007-12-31
• Decision Date: 2008-03-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00815131021783	K073713	000
00815131022544	K073713	000
00815131022551	K073713	000
00815131022568	K073713	000
00815131022575	K073713	000
00815131022582	K073713	000
00815131022599	K073713	000
00815131022605	K073713	000
00815131022612	K073713	000
00815131022629	K073713	000
00815131022636	K073713	000
00815131022537	K073713	000
00815131022520	K073713	000
00815131021837	K073713	000
00815131022346	K073713	000
00815131022353	K073713	000
00815131022384	K073713	000
00815131022391	K073713	000
00815131022407	K073713	000
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00815131022490	K073713	000
00815131022506	K073713	000
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00815131022858	K073713	000
00815131022865	K073713	000
00815131023978	K073713	000
00815131024050	K073713	000
00815131024067	K073713	000
00815131024074	K073713	000
00815131024081	K073713	000
00815131024098	K073713	000
00815131024104	K073713	000
00815131024265	K073713	000
00815131024272	K073713	000
00815131024289	K073713	000
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00815131023954	K073713	000
00815131022872	K073713	000
00815131023053	K073713	000
00815131023060	K073713	000
00815131023077	K073713	000
00815131023220	K073713	000
00815131023237	K073713	000
00815131023244	K073713	000
00815131023695	K073713	000
00815131023930	K073713	000
00815131023947	K073713	000
00815131024296	K073713	000