Class Class II
T3 Pro Implants– ZimVie Packaging System (K251660)
Description
T3 Pro Implants– ZimVie Packaging System by Biomet 3i, LLC, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251660
Clearance Date2025-06-27
Clearance TypeSpecial
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251660
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. T3 Pro Implants– ZimVie Packaging System (K251660) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220978 | TSX Implants | Biomet 3i, LLC | 2022 |
| K213672 | T3 Pro Implants | Biomet 3i, LLC | 2022 |
| K122300 | T3 DENTAL IMPLANT | Biomet 3i | 2013 |
| K082639 | ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS | Zimmer Dental, Inc. | 2008 |
| K063286 | OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE | Implant Innovations, Inc. | 2007 |
Trace the full predicate network for K251660
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.