# K073070: Dio Biotite-H Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dio Department Dsi, Inc.
- Decided: May 16, 2008 after 199 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K852682 (1985). 12 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955428: 3I Hydroxylapatite Coated Standard Threaded & Self-Tapping Implants, Implant Innovations, Inc. (1996) Summary page 1.
- K882682: Compat Enteral Delivery System, Sandoz Nutrition (1988) Summary page 3.
- K852742: Osteograf AR Alveolar Ridge Hydroxylapatite 18-40, Coors Biomedical Co. (1985) Summary page 3.
- K852765: HA-2000 Hydroxylapatite, Orthomatrix, Inc. (1985) Summary page 3.
- K992416: Perioglas- Bioglass Bone Graft Particulate, Usbiomaterials Corp. (1999) Summary page 3.
- K000149: Novabone-Bioglass Bone Graft Particulate, Usbiomaterials Corp. (2000) Summary page 3.
- K952922: Biogran Bioactive Glass Synthetic Bone Graft Material, Orthovita Co. (1995) Summary page 3.
- K921468: Permamesh Hydroxylapatite Matrix, Ceramed Corp. (1992) Summary page 3.
- K862061: Osteograf/AR+ Permaridge Hydroxylapatite, 18-40, Coors Biomedical Co. (1986) Summary page 3.
- K910432: Hapset Hydroxylapatite Bone Graft Plaster, Lifecore Biomedical, Inc. (1991) Summary page 3.

## Cited in the summary but kept off the family tree
- K940348: Trauma Pad 5 X 9, Certified Safety Mfg., Inc. (1994). Our reading of the summary gave K940348, FDA’s number for Trauma Pad 5 X 9 (Certified Safety Mfg., Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “OsteoGraft/D-700”. Kept off the family tree. Summary page 3.

## Most influential descendants
- K112532: ET II Bio-SA Fixture System (2012), 10 descendants of its own
- K151626: ET III Bio-SA Fixture System (2016), 9 descendants of its own
- K203360: EK Implants and Abutments System (2022), 7 descendants of its own
- K221866: S-Plant Dental Implant System (2024), 2 descendants of its own
- K133362: SGS Dental Implant (2014), 2 descendants of its own

## Indications for use
The DIO Biotite-H Implant System is an endosseous dental implant that is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Also, angled abutments on small diameter implants (3.8mm) of the DIO Biotite-H Implant System are intended for the anterior region of the mouth and not intended for the posterior region of the mouth due to possible failure of the implant.

Source page: https://510kreport.com/device/K073070
Methodology: https://510kreport.com/methodology