The following data is part of a premarket notification filed by Lk Consulting Group Usa, Inc. with the FDA for Kerator.
| Device ID | K132144 |
| 510k Number | K132144 |
| Device Name: | KERATOR |
| Classification | Implant, Endosseous, Root-form |
| Applicant | LK Consulting Group USA, Inc. 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92831 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92831 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-11 |
| Decision Date | 2014-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809488213375 | K132144 | 000 |
| 08809488213160 | K132144 | 000 |
| 08809488213153 | K132144 | 000 |
| 08809488213146 | K132144 | 000 |
| 08809488213139 | K132144 | 000 |
| 08809488213122 | K132144 | 000 |
| 08809488213115 | K132144 | 000 |
| 08809488213108 | K132144 | 000 |
| 08809488213092 | K132144 | 000 |
| 08809488213085 | K132144 | 000 |
| 08809488213078 | K132144 | 000 |
| 08809488213061 | K132144 | 000 |
| 08809488213054 | K132144 | 000 |
| 08809488213047 | K132144 | 000 |
| 08809488213030 | K132144 | 000 |
| 08809488213023 | K132144 | 000 |
| 08809488213429 | K132144 | 000 |
| 08809488213412 | K132144 | 000 |
| 08809488213177 | K132144 | 000 |
| 08809488213184 | K132144 | 000 |
| 08809488213191 | K132144 | 000 |
| 08809488213368 | K132144 | 000 |
| 08809488213351 | K132144 | 000 |
| 08809488213344 | K132144 | 000 |
| 08809488213337 | K132144 | 000 |
| 08809488213320 | K132144 | 000 |
| 08809488213313 | K132144 | 000 |
| 08809488213306 | K132144 | 000 |
| 08809488213290 | K132144 | 000 |
| 08809488213283 | K132144 | 000 |
| 08809488213276 | K132144 | 000 |
| 08809488213269 | K132144 | 000 |
| 08809488213252 | K132144 | 000 |
| 08809488213245 | K132144 | 000 |
| 08809488213238 | K132144 | 000 |
| 08809488213221 | K132144 | 000 |
| 08809488213214 | K132144 | 000 |
| 08809488213207 | K132144 | 000 |
| 08809488213405 | K132144 | 000 |