Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack (K251062)
Description
Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack by Geistlich Pharma AG, an FDA 510(k) cleared dental device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251062
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. Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack (K251062) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212463 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio... | Geistlich Pharma AG | 2022 |
| K171643 | Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed | Geistlich Pharma AG | 2017 |
| K112572 | GEISTLICH COMBI-KIT COLLEGEN | Geistlich Pharma AG | 2011 |
| K050446 | BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND ... | Ed. Geistlich Soehne AG Fuer Chemis... | 2005 |
| K042197 | BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND ... | Ed. Geistlich Soehne AG Fuer Chemis... | 2004 |
Trace the full predicate network for K251062
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.