INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM

Implant, Endosseous, Root-form

CALCITEK, INC.

The following data is part of a premarket notification filed by Calcitek, Inc. with the FDA for Integral Vi Biointegrated Dental Implant System.

Pre-market Notification Details

• Device ID: K944327
• 510k Number: K944327
• Device Name: INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: CALCITEK, INC. 2320 FARADAY AVE. Carlsbad, CA 92008 -7216
• Contact: Carole A White
• Correspondent: Carole A White; CALCITEK, INC. 2320 FARADAY AVE. Carlsbad, CA 92008 -7216
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-09-02
• Decision Date: 1995-05-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889024012257	K944327	000
00889024011786	K944327	000
00889024011793	K944327	000
00889024011809	K944327	000
00889024011816	K944327	000
00889024011823	K944327	000
00889024011830	K944327	000
00889024011847	K944327	000
00889024011854	K944327	000
00889024011861	K944327	000
00889024011878	K944327	000
00889024011885	K944327	000
00889024011892	K944327	000
00889024011779	K944327	000
00889024011762	K944327	000
00889024012356	K944327	000
00889024012370	K944327	000
00889024012417	K944327	000
00889024012424	K944327	000
00889024012431	K944327	000
00889024012882	K944327	000
00889024012899	K944327	000
00889024011687	K944327	000
00889024011694	K944327	000
00889024011731	K944327	000
00889024011748	K944327	000
00889024011755	K944327	000
00889024011908	K944327	000
00889024011915	K944327	000
00889024011922	K944327	000
00889024012226	K944327	000
00889024012233	K944327	000
00889024012240	K944327	000
00889024012493	K944327	000
00889024012509	K944327	000
00889024012516	K944327	000
00889024012523	K944327	000
00889024012554	K944327	000
00889024012752	K944327	000
00889024012820	K944327	000
00889024013322	K944327	000
00889024013346	K944327	000
00889024012219	K944327	000
00889024012202	K944327	000
00889024011939	K944327	000
00889024011946	K944327	000
00889024011953	K944327	000
00889024011960	K944327	000
00889024011977	K944327	000
00889024011984	K944327	000
00889024011991	K944327	000
00889024012097	K944327	000
00889024012141	K944327	000
00889024012172	K944327	000
00889024012189	K944327	000
00889024012196	K944327	000
00889024013353	K944327	000