REPLACE TITANIUM IMPLANT SYSTEM

Implant, Endosseous, Root-form

STERI-OSS, INC.

The following data is part of a premarket notification filed by Steri-oss, Inc. with the FDA for Replace Titanium Implant System.

Pre-market Notification Details

• Device ID: K964220
• 510k Number: K964220
• Device Name: REPLACE TITANIUM IMPLANT SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: STERI-OSS, INC. 22895 EASTPARK DR. Yorba Linda, CA 92887
• Contact: Paul Gasser
• Correspondent: Paul Gasser; STERI-OSS, INC. 22895 EASTPARK DR. Yorba Linda, CA 92887
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-10-22
• Decision Date: 1997-03-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07332747016222	K964220	000
07332747003369	K964220	000
07332747003352	K964220	000
07332747002928	K964220	000
07332747002911	K964220	000
07332747002904	K964220	000
07332747002898	K964220	000
07332747002881	K964220	000
07332747002874	K964220	000
07332747002867	K964220	000
07332747002850	K964220	000
07332747002843	K964220	000
07332747002836	K964220	000
07332747002829	K964220	000
07332747002812	K964220	000
07332747002805	K964220	000
07332747002799	K964220	000
07332747002782	K964220	000
07332747003390	K964220	000
07332747003406	K964220	000
07332747016215	K964220	000
07332747016208	K964220	000
07332747016192	K964220	000
07332747016079	K964220	000
07332747016062	K964220	000
07332747016055	K964220	000
07332747016048	K964220	000
07332747016031	K964220	000
07332747016024	K964220	000
07332747016017	K964220	000
07332747016000	K964220	000
07332747015997	K964220	000
07332747015980	K964220	000
07332747015966	K964220	000
07332747015959	K964220	000
07332747015942	K964220	000
07332747015850	K964220	000
07332747002775	K964220	000