510(k) · Cleared
ClearedDio Biotite-H Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dio Department Dsi, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on May 16, 2008 as substantially equivalent to K955428 (Implant Innovations, Inc., 1996) and 9 other predicates after a 199-day review. Its family tree reaches back 2 generations to 1985. 16 later devices descend from it.
- Decided
- May 16, 2008
- Review
- 199 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 2 generations to K852682 (1985). 12 ancestors in all, the oldest K852765 (1985). 16 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK852682 Calcitite Bone Graft Mat/Oral & Maxillofacial SurgCalcitek, Inc. · 1985
- 1 generation backK992416 Perioglas- Bioglass Bone Graft ParticulateUsbiomaterials Corp. · 1999
- This deviceK073070 Dio Biotite-H Implant SystemDio Department Dsi, Inc. · 2008
- Descendant · cites it directly · 10 of its ownK112532 ET II Bio-SA Fixture SystemHiossen, Inc. · 2012
- Descendant · 2 generations on · 9 of its ownK151626 ET III Bio-SA Fixture SystemHiossen, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 7 of its ownK203360 EK Implants and Abutments SystemHiossen, Inc. · 2022
- Descendant · 4 generations on · 2 of its ownK221866 S-Plant Dental Implant SystemNewton Implant Systems, Inc. · 2024
- Descendant · cites it directly · 2 of its ownK133362 SGS Dental ImplantSgs International, Ltd. · 2014
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K112532ET II Bio-SA Fixture SystemHiossen, Inc. · 2012 · cites it directly10descendants
- K151626ET III Bio-SA Fixture SystemHiossen, Inc. · 2016 · 2 generations on9descendants
- K203360EK Implants and Abutments SystemHiossen, Inc. · 2022 · 3 generations on7descendants
- K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc. · 2024 · 4 generations on2descendants
- K133362SGS Dental ImplantSgs International, Ltd. · 2014 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K852682 | Calcitite Bone Graft Mat/Oral & Maxillofacial Surg | Calcitek, Inc. | 1985 | — |
| −1 | K992416 | Perioglas- Bioglass Bone Graft Particulate | Usbiomaterials Corp. | 1999 | — |
| 0 (this device) | K073070 | Dio Biotite-H Implant System | Dio Department Dsi, Inc. | 2008 | — |
| +1 | K112532 | ET II Bio-SA Fixture System | Hiossen, Inc. | 2012 | — |
| +2 | K151626 | ET III Bio-SA Fixture System | Hiossen, Inc. | 2016 | 1 |
| +3 | K203360 | EK Implants and Abutments System | Hiossen, Inc. | 2022 | — |
| +4 | K221866 | S-Plant Dental Implant System | Newton Implant Systems, Inc. | 2024 | — |
| +1 | K133362 | SGS Dental Implant | Sgs International, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (11)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K955428 | 3I Hydroxylapatite Coated Standard Threaded & Self-Tapping ImplantsSummary page 1…l Devices panel 21 CFR 4 872.3640 Regulation Number: 15-7. Predicate Devices IMPLANT INOVATION, INC. (K 955428) 15-8. Performance Laboratory testing was conducted to determine device functionality… | 1996 |
| Kept off the family tree | K940348 | FDA’s K940348 is Trauma Pad 5 X 9 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…es that are substantially equivalent to the Calcium Hydroxylapatite Implant: K955428 Implant Innovation, Inc. 3i Hydroxylapatite Coated Standard Thread K940348 OsteoGraft/D-700 CeraMed Corporation. 12860 West cedar Drive. Lakewood, Co 80228 K882682 alcitie… | 1994 |
| * | K882682 | Compat Enteral Delivery SystemSummary page 3…tion, Inc. 3i Hydroxylapatite Coated Standard Thread K940348 OsteoGraft/D-700 CeraMed Corporation. 12860 West cedar Drive. Lakewood, Co 80228 K882682 alcitie Calcitek, Inc., 4125-B Sorrento Valley Boulevard, San Diego, CA 92121 K852742 Osteograf AR Alveolar R… | 1988 |
| * | K852742 | Osteograf AR Alveolar Ridge Hydroxylapatite 18-40Summary page 3…CeraMed Corporation. 12860 West cedar Drive. Lakewood, Co 80228 K882682 alcitie Calcitek, Inc., 4125-B Sorrento Valley Boulevard, San Diego, CA 92121 K852742 Osteograf AR Alveolar Ridge Hydroxylapatite 18-40 Coors Biomedical Company, 12860 West Cedar Drive, L… | 1985 |
| * | K852765 | HA-2000 HydroxylapatiteSummary page 3…iego, CA 92121 K852742 Osteograf AR Alveolar Ridge Hydroxylapatite 18-40 Coors Biomedical Company, 12860 West Cedar Drive, Lakewood, CO 80228 K852765 HA-2000 Orthomatrix, Inc., 6968 Sierra Court, Dublin CA 94568 K992416 Perioglas-BioGlass Bone Graft Particula… | 1985 |
| * | K992416 | Perioglas- Bioglass Bone Graft ParticulateSummary page 3…Coors Biomedical Company, 12860 West Cedar Drive, Lakewood, CO 80228 K852765 HA-2000 Orthomatrix, Inc., 6968 Sierra Court, Dublin CA 94568 K992416 Perioglas-BioGlass Bone Graft Particulate U.S. Biomaterials Corp., One Progress Boulevard, Alachua, F… | 1999 |
| * | K000149 | Novabone-Bioglass Bone Graft ParticulateSummary page 3…a Court, Dublin CA 94568 K992416 Perioglas-BioGlass Bone Graft Particulate U.S. Biomaterials Corp., One Progress Boulevard, Alachua, FL 32615 K000149 Novabone-Bioglass Bone Graft Particulate U.S. Biomaterials Corp., One Progress Boulevard, Alachua, FL… | 2000 |
| * | K952922 | Biogran Bioactive Glass Synthetic Bone Graft MaterialSummary page 3…hua, FL 32615 K000149 Novabone-Bioglass Bone Graft Particulate U.S. Biomaterials Corp., One Progress Boulevard, Alachua, FL 32615 K952922 Biogran Bioactive Glass Synthetic Bone Graft Material Orthovita Co., 212 Carnegie Center Drive, Suite 206,… | 1995 |
| * | K921468 | Permamesh Hydroxylapatite MatrixSummary page 3…32615 K952922 Biogran Bioactive Glass Synthetic Bone Graft Material Orthovita Co., 212 Carnegie Center Drive, Suite 206, Princeton, NJ 08540 K921468 PermanMesh Hydroxylapatite Matrix CeraMed Corp., 12860 West Cedar Drive, Lakewood, CO 80228 K862061 Osteograf… | 1992 |
| * | K862061 | Osteograf/AR+ Permaridge Hydroxylapatite, 18-40Summary page 3…ter Drive, Suite 206, Princeton, NJ 08540 K921468 PermanMesh Hydroxylapatite Matrix CeraMed Corp., 12860 West Cedar Drive, Lakewood, CO 80228 K862061 Osteograf/AR+Permaridge Hydroxylapatite, 18-40 Coors Biomedical Company, 12860 West Cedar Drive, Lakewood, CO 80… | 1986 |
| * | K910432 | Hapset Hydroxylapatite Bone Graft PlasterSummary page 3…ar Drive, Lakewood, CO 80228 K862061 Osteograf/AR+Permaridge Hydroxylapatite, 18-40 Coors Biomedical Company, 12860 West Cedar Drive, Lakewood, CO 80228 K910432 HAPSET Hydroxylapatite Bone Graft Plaster Lifecore Biomedical, Inc., 1050 Connecticut Avenue, N.W. Wa… | 1991 |
What descends from it? (16)
See all 163 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 14.1 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K112532 (Hiossen, Inc., 2012) has gone furthest, with 10 descendants of its own.
- 4 other devices also cite its predicate K955428.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073070 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073070: Dio Biotite-H Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073070
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026