O-RING PROSTHETIC ATTACHMENT DEVICE

Implant, Endosseous, Root-form

CALCITEK, INC.

The following data is part of a premarket notification filed by Calcitek, Inc. with the FDA for O-ring Prosthetic Attachment Device.

Pre-market Notification Details

• Device ID: K900545
• 510k Number: K900545
• Device Name: O-RING PROSTHETIC ATTACHMENT DEVICE
• Classification: Implant, Endosseous, Root-form
• Applicant: CALCITEK, INC. 2320 FARADAY AVE. Carlsbad, CA 92008 -7216
• Contact: M Carlson
• Correspondent: M Carlson; 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: 1990-02-05
• Decision Date: 1990-06-22

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889024011328	K900545	000
00889024011311	K900545	000
00889024011304	K900545	000