The following data is part of a premarket notification filed by Steri-oss, Inc. with the FDA for Steri-oss' Improv Temporary Dental Cement.
| Device ID | K982400 |
| 510k Number | K982400 |
| Device Name: | STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT |
| Classification | Cement, Dental |
| Applicant | STERI-OSS, INC. 22895 EASTPARK DR. Yorba Linda, CA 92887 |
| Contact | Jeff Hausheer |
| Correspondent | Jeff Hausheer STERI-OSS, INC. 22895 EASTPARK DR. Yorba Linda, CA 92887 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-10 |
| Decision Date | 1998-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D801SP55411 | K982400 | 000 |
| D801SP55401 | K982400 | 000 |
| D801IMPROVECEMENT1 | K982400 | 000 |
| D801AV44001 | K982400 | 000 |