510(k) · Cleared
ClearedALLONUS Tech Prosthetics
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allonus Tech Co., Ltd. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Dec 17, 2024 as substantially equivalent to K150203 (Medentika GmbH, 2015) and 3 other predicates after a 195-day review. Its family tree reaches back 14 generations to 1990.
- Decided
- Dec 17, 2024
- Review
- 195 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K894844 (1990). 196 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 14 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 10 generations between
- 3 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 2 generations backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- 1 generation backK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- This deviceK241616 ALLONUS Tech ProstheticsAllonus Tech Co., Ltd. · 2024
Show all 14 generations
- Root · 14 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 13 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 12 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 11 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 10 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 9 generations backK052272 Straumann Computer Aided Restoration ServiceStraumann USA · 2006
- 8 generations backK061277 Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic…Straumann USA · 2007
- 7 generations backK072151 P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA · 2007 · Recalled
- 6 generations backK081005 P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008 · Recalled
- 5 generations backK082545 Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG · 2008
- 4 generations backK093113 Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG · 2009
- 3 generations backK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
- 2 generations backK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- 1 generation backK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- This deviceK241616 ALLONUS Tech ProstheticsAllonus Tech Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −13 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −12 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −11 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −10 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −9 | K052272 | Straumann Computer Aided Restoration Service | Straumann USA | 2006 | — |
| −8 | K061277 | Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic Coping | Straumann USA | 2007 | — |
| −7 | K072151 | P.004 RC Cares Titanium and Ceramic Abutments | Straumann USA | 2007 | 1 |
| −6 | K081005 | P.004 NC Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | 1 |
| −5 | K082545 | Straumann NN Cares Titanium and Ceramic Abutments | Institut Straumann AG | 2008 | — |
| −4 | K093113 | Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam Abutment | Institut Straumann AG | 2009 | — |
| −3 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
| −2 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| −1 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| 0 (this device) | K241616 | ALLONUS Tech Prosthetics | Allonus Tech Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 13 | 0 |
| 1994 | 11 | 0 |
| 1995 | 9 | 0 |
| 1996 | 14 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 8 | 0 |
| 2000 | 7 | 0 |
| 2001 | 10 | 0 |
| 2002 | 15 | 0 |
| 2003 | 8 | 0 |
| 2004 | 11 | 0 |
| 2005 | 9 | 0 |
| 2006 | 16 | 0 |
| 2007 | 14 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K150203 | Medentika CAD/CAM AbutmentsSummary page 5…tal, Endosseous Regulation Number 21 CFR 872.3630 Device Classification Class II Product Code NHA 3) Predicate Device Primary Predicate: K150203 Medentika CAD/CAM Abutment, Medentika GmbH Reference Devices: K120414 Astra OsseoSpeed EV by Astra Tech,… | 2015 |
| * | K072570 | Nobelactive Multi Unit AbutmentSummary page 6…and Tapered Screw Vent K241485 TruAbutment DS, TruAbutment Inc. K234142 TiGEN Abutment, PMMA Abutment and Scan Healing Abutment, MegaGen Implant Co., Ltd. K072570 NOBELACTIVE MULTI UNIT ABUTMENT by NOBEL BIOCARE AB K171142 Healing Cap Multi-Unit Titanium by NOBEL BIOCARE AB K123988 ANY… | 2007 |
| * | K171142 | Healing Cap Multi-Unit TitaniumSummary page 6…Inc. K234142 TiGEN Abutment, PMMA Abutment and Scan Healing Abutment, MegaGen Implant Co., Ltd. K072570 NOBELACTIVE MULTI UNIT ABUTMENT by NOBEL BIOCARE AB K171142 Healing Cap Multi-Unit Titanium by NOBEL BIOCARE AB K123988 ANYONETM INTERNAL IMPLANT SYSTEM by MEGAGEN IMPLANT CO.… | 2017 |
| * | K123988 | Anyonetm Internal Implant SystemSummary page 6…Abutment, MegaGen Implant Co., Ltd. K072570 NOBELACTIVE MULTI UNIT ABUTMENT by NOBEL BIOCARE AB K171142 Healing Cap Multi-Unit Titanium by NOBEL BIOCARE AB K123988 ANYONETM INTERNAL IMPLANT SYSTEM by MEGAGEN IMPLANT CO., LTD Page 2 / 21… | 2013 |
| † | K234142 | TiGEN Abutment, PMMA Abutment and Scan Healing Abutment | 2024 |
| † | K241485 | TruAbutment DS; TruBase | 2024 |
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 34 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 20 of the 196 ancestors have a recall of any class.
- 13 other devices also cite its predicate K150203.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
ALLONUS Tech Prosthetic is intended for use with dental implants as a support for single or multiple-unit prosthetic restorations in the maxilla or mandible of partially or fully edentulous patient. It is including; cemented retained, screw-retained, or overdenture restorations. It is compatible with the following systems: • Astra OsseoSpeed EV(K130999) 3.0 • Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm • Tapered Internal Implants (K071638)…
Read the full statement (248 words)
ALLONUS Tech Prosthetic is intended for use with dental implants as a support for single or multiple-unit prosthetic restorations in the maxilla or mandible of partially or fully edentulous patient. It is including; cemented retained, screw-retained, or overdenture restorations.
It is compatible with the following systems:
• Astra OsseoSpeed EV(K130999) 3.0
• Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm
• Tapered Internal Implants (K071638) (K143022) 3.4, 3.8, 4.6, 5.8 mm
• BioHorizons Laser-Lok Implant System (K093321) 3.0 mm
• Conelog Screw-Line (K113779) 3.3, 3.8, 4.3, 5.0 mm
• Osstem TSIII SA (K121995) 3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) mm (Mini, Regular)
• Megagen AnyRidge Internal Implant System (K140091) 4.0, 4.4, 4.9, 5.4 (3.1)
• Neodent Implant System - GM Helix (K163194, Kl80536) 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
• Nobel Active 3.0 (K102436) 3.0
• Nobel Active Internal Connection Implant (K071370) NP RP
• Nobelactive Wide Platform (Wp) (K133731) WP
• Straumann BLX Implant (Kl73961, Kl81703, K191256) 3.5, 3.75, 4.5, 5.5, 6.5 (RB, WB)
• Straumann 02.9 mm Bone Level Tapered Implants, SC CARES Abutments (Kl62890) 2.9 (SC)
• Straumann® Bone Level Tapered Implants (K140878) 3.3, 4.1, 4.8 (NC, RC)
• Zimmer 3.1mmD Dental Implant System (K142082) 3.1 (2.9)
• (Ti-base only) Screw Vent® and Tapered Screw Vent® (K013227) 3.7(3.5), 4.7(4.5), 6.0(5.7)
All digitally designed abutments and/or coping for use with the abutments are intended to be sent to a ALLONUS Tech-validated milling center for manufacture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241616: ALLONUS Tech Prosthetics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241616
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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