Class Class II
HEXIM Implant; Samwon General Abutments (K243731)
Description
HEXIM Implant; Samwon General Abutments by P&A USA, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243731
Clearance Date2025-07-09
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243731
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. HEXIM Implant; Samwon General Abutments (K243731) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221866 | S-Plant Dental Implant System | Newton Implant Systems, Inc. | 2024 |
| K222792 | SNUCONE Tissue Level Implant System | Snucone Co., Ltd. | 2023 |
| K190641 | AR_N SLA Type Implant System | Biotem Co., Ltd. | 2020 |
| K111889 | ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT | Zimmer Dental, Inc. | 2011 |
Trace the full predicate network for K243731
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.