The following data is part of a premarket notification filed by Achimhai Medical Corporation with the FDA for Kisses Plus Implant System.
| Device ID | K200193 |
| 510k Number | K200193 |
| Device Name: | Kisses Plus Implant System |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | ACHIMHAI Medical Corporation 28, Namyang-ro, 930beon-gil, Namyang-eup Hwaseong-si, KR 18255 |
| Contact | Ji Ho Jung |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt, STE 200 Irvine, CA 92620 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-27 |
| Decision Date | 2021-08-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800024953083 | K200193 | 000 |
| 08800024918952 | K200193 | 000 |
| 08800024918969 | K200193 | 000 |
| 08800024918976 | K200193 | 000 |
| 08800024918983 | K200193 | 000 |
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| 08800024953502 | K200193 | 000 |
| 08800024953564 | K200193 | 000 |
| 08800024953571 | K200193 | 000 |
| 08800024918945 | K200193 | 000 |
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| 08800024918853 | K200193 | 000 |
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| 08800024918907 | K200193 | 000 |
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| 08800024953045 | K200193 | 000 |
| 08800024953052 | K200193 | 000 |
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| 08800024952604 | K200193 | 000 |
| 08800024952611 | K200193 | 000 |
| 08800024952628 | K200193 | 000 |
| 08800024918846 | K200193 | 000 |