510(k) · Cleared
ClearedBhdental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bhdental, Ltd. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Feb 24, 2011 as substantially equivalent to K063364 (Alpha-Bio Tec, Ltd., 2007) and 6 other predicates after a 111-day review. Its family tree reaches back 11 generations to 1996.
- Decided
- Feb 24, 2011
- Review
- 111 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 11 generations to K960026 (1996). 134 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 7 generations between
- 3 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 2 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 1 generation backK071803 Ards Dental ImplantsArds, Ltd. · 2008
- This deviceK103280 Bhdental Implant SystemBhdental, Ltd. · 2011
Show all 11 generations
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 10 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 9 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 8 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 4 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 3 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 2 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 1 generation backK071803 Ards Dental ImplantsArds, Ltd. · 2008
- This deviceK103280 Bhdental Implant SystemBhdental, Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −10 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −9 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −8 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −4 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −3 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −2 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −1 | K071803 | Ards Dental Implants | Ards, Ltd. | 2008 | — |
| 0 (this device) | K103280 | Bhdental Implant System | Bhdental, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1993 | 11 | 0 |
| 1994 | 10 | 0 |
| 1995 | 8 | 0 |
| 1996 | 11 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 9 | 0 |
| 2000 | 6 | 0 |
| 2001 | 11 | 0 |
| 2002 | 12 | 0 |
| 2003 | 8 | 0 |
| 2004 | 7 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063364 | Alpha Bio Dental Implant SystemSummary page 1…5.9 Regulation Number: 872.3640 5.10 Review Panel: Dental 5.11 Predicate Devices: *Alpha-Bio Tec®)Dental Implant System (Alpha-Bio Tec Ltd) cleared under K063364; product code DZE (Implant, Endosseous, Root-Form) *ONEPLANT Dental Implant System (WARANTEC Co., Ltd.) cleared under… | 2007 |
| * | K081748 | Oneplant Dental Implant SystemSummary page 1…o Tec Ltd) cleared under K063364; product code DZE (Implant, Endosseous, Root-Form) *ONEPLANT Dental Implant System (WARANTEC Co., Ltd.) cleared under K081748; product code DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous) *MIS Dental Implan… | 2009 |
| * | K040807 | Mis Dental Implant SystemSummary page 1…ant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous) *MIS Dental Implant System (MIS - Implant Technologies Ltd.) cleared under K040807; product code DZE (Implant, Endosseous, Root-Form) * Osseospeed TM Profile System (ASTRA Tech AB) cleared unde… | 2004 |
| * | K080156 | Osseospeed TM Profile SystemSummary page 2…td.) cleared under K040807; product code DZE (Implant, Endosseous, Root-Form) * Osseospeed TM Profile System (ASTRA Tech AB) cleared under K080156, K091239) ; product code DZE (implant, Endosseous, Root- Form) e ARSO Dental Implants (ARDS Ltd.) cleared under K071803 ;… | 2008 |
| * | K091239 | Astra Tech Implant SystemSummary page 2…red under K040807; product code DZE (Implant, Endosseous, Root-Form) * Osseospeed TM Profile System (ASTRA Tech AB) cleared under K080156, K091239) ; product code DZE (implant, Endosseous, Root- Form) e ARSO Dental Implants (ARDS Ltd.) cleared under K071803 ;product c… | 2009 |
| * | K071803 | Ards Dental ImplantsSummary page 2…System (ASTRA Tech AB) cleared under K080156, K091239) ; product code DZE (implant, Endosseous, Root- Form) e ARSO Dental Implants (ARDS Ltd.) cleared under K071803 ;product code OZE (Implant, Endlosseous, Root-Form) * NobleActive internal Connection Implant (Nobel Biocare AB) cleared… | 2008 |
| * | K071370 | Nobelactive Internal Connection ImplantSummary page 2…S Ltd.) cleared under K071803 ;product code OZE (Implant, Endlosseous, Root-Form) * NobleActive internal Connection Implant (Nobel Biocare AB) cleared under K071370;product code DZE (Implant, Endosseous, Root-Form); product code NHA (Abutment, Implant, Dental, Endossbous). 5.12 Intende… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 16 of the 134 ancestors have a recall of any class.
- 12 other devices also cite its predicate K063364.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
The BHdental Implant system is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic. devices, such as artificial teeth, in order to restore the patient chewing function. The BHdental Implant System is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103280 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103280: Bhdental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103280
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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