The following data is part of a premarket notification filed by Kj Meditech Co., Ltd with the FDA for Hero I Dental Implant System.
| Device ID | K121098 |
| 510k Number | K121098 |
| Device Name: | HERO I DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | KJ MEDITECH CO., LTD 951 STARBUCK ST. UNIT J Fullerton, CA 92833 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung KJ MEDITECH CO., LTD 951 STARBUCK ST. UNIT J Fullerton, CA 92833 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-11 |
| Decision Date | 2013-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809488217458 | K121098 | 000 |
| 08809488217311 | K121098 | 000 |
| 08809488217304 | K121098 | 000 |
| 08809488217298 | K121098 | 000 |
| 08809488217281 | K121098 | 000 |
| 08809488217274 | K121098 | 000 |
| 08809488217267 | K121098 | 000 |
| 08809488217250 | K121098 | 000 |
| 08809488217243 | K121098 | 000 |
| 08809488217236 | K121098 | 000 |
| 08809488217229 | K121098 | 000 |
| 08809488217212 | K121098 | 000 |
| 08809488217328 | K121098 | 000 |
| 08809488217335 | K121098 | 000 |
| 08809488217441 | K121098 | 000 |
| 08809488217434 | K121098 | 000 |
| 08809488217427 | K121098 | 000 |
| 08809488217410 | K121098 | 000 |
| 08809488217403 | K121098 | 000 |
| 08809488217397 | K121098 | 000 |
| 08809488217380 | K121098 | 000 |
| 08809488217373 | K121098 | 000 |
| 08809488217366 | K121098 | 000 |
| 08809488217359 | K121098 | 000 |
| 08809488217342 | K121098 | 000 |
| 08809488217205 | K121098 | 000 |