The following data is part of a premarket notification filed by Steri-oss, Inc. with the FDA for Steri-oss Gold Attachment System.
Device ID | K963945 |
510k Number | K963945 |
Device Name: | STERI-OSS GOLD ATTACHMENT SYSTEM |
Classification | Implant, Endosseous, Root-form |
Applicant | STERI-OSS, INC. 22895 EASTPARK DR. Yorba Linda, CA 92887 |
Contact | Don Kennard |
Correspondent | Don Kennard 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 | 1996-10-02 |
Decision Date | 1997-02-11 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07332747010534 | K963945 | 000 |
07332747010381 | K963945 | 000 |
07332747010350 | K963945 | 000 |
17332747000013 | K963945 | 000 |