Class Class II
Titanium Abutment Blank Nobel Biocare N1 TCC (K223677)
Description
Titanium Abutment Blank Nobel Biocare N1 TCC by Nobel Biocare AB, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223677
Clearance Date2023-04-28
Clearance TypeTraditional
Product CodeNHA
Regulation Number872.3630
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223677
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. Titanium Abutment Blank Nobel Biocare N1 TCC (K223677) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222044 | Elos Accurate Customized Abutment | Elos Medtech Pinol A/S | 2022 |
| K222288 | DESS Dental Smart Solutions | Terrats Medical SL | 2022 |
| K151455 | 3Shape Abutment Designer Software | 3Shape A/S | 2016 |
| K122602 | NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS | Nobel Biocare AB | 2013 |
| K053602 | PROCERA SOFTWARE, MODEL 33145 | Nobel Biocare AB | 2006 |
Trace the full predicate network for K223677
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.