510(k) · Cleared
ClearedAllfim Implant Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cowellmedi Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jul 28, 2005 as substantially equivalent to K041655 (Cowellmedi Co., Ltd., 2004) and 4 other predicates after a 119-day review. Its family tree reaches back 6 generations to 1995. 5 later devices descend from it.
- Decided
- Jul 28, 2005
- Review
- 119 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K944964 (1995). 52 ancestors in all, the oldest K874590 (1988). 5 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 5 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 4 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 3 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 2 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 1 generation backK041655 Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd. · 2004
- This deviceK050635 Allfim Implant SystemsCowellmedi Co., Ltd. · 2005
- Descendant · cites it directly · 4 of its ownK071148 Atlas Implant SystemCowellmedi Co., Ltd. · 2008
- Descendant · 2 generations on · 1 of its ownK120043 CSM Internal-R Implant SystemCsm Implant · 2012
- Descendant · 2 generations on · 1 of its ownK090054 Atlas Implant System - Wide PlusCowellmedi Co., Ltd. · 2009
- Descendant · 3 generations on · 0 of its ownK173141 CSM Submerged3-L Implant SystemCsm Implant · 2018
- Descendant · 3 generations on · 0 of its ownK090377 Sinus Quick EB SystemNeobiotech Co., Ltd. · 2009
Most influential descendants
Showing 5 of 5 · See all- K071148Atlas Implant SystemCowellmedi Co., Ltd. · 2008 · cites it directly4descendants
- K120043CSM Internal-R Implant SystemCsm Implant · 2012 · 2 generations on1descendant
- K090054Atlas Implant System - Wide PlusCowellmedi Co., Ltd. · 2009 · 2 generations on1descendant
- K173141CSM Submerged3-L Implant SystemCsm Implant · 2018 · 3 generations on0descendants
- K090377Sinus Quick EB SystemNeobiotech Co., Ltd. · 2009 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −5 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −4 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −3 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −2 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −1 | K041655 | Bio Plant System (Implants and Abutments) | Cowellmedi Co., Ltd. | 2004 | — |
| 0 (this device) | K050635 | Allfim Implant Systems | Cowellmedi Co., Ltd. | 2005 | — |
| +1 | K071148 | Atlas Implant System | Cowellmedi Co., Ltd. | 2008 | — |
| +2 | K120043 | CSM Internal-R Implant System | Csm Implant | 2012 | — |
| +2 | K090054 | Atlas Implant System - Wide Plus | Cowellmedi Co., Ltd. | 2009 | — |
| +3 | K173141 | CSM Submerged3-L Implant System | Csm Implant | 2018 | — |
| +3 | K090377 | Sinus Quick EB System | Neobiotech Co., Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 10 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2018 | 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 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? (5)
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 |
|---|---|---|---|
| * | K041655 | Bio Plant System (Implants and Abutments)Summary page 1…l 21 CFR~ 872.3640 Regulation Number: 872.3640 10-7. Predicate Devices BIOPLANT Implant Systems (K041655) & K971706)… | 2004 |
| * | K925777 | Branemark System Estheticone Abutment CompleteSummary page 1…lant Systems (K041655) & K971706) Branemark Systems (K925777, K925779, K961728, device 1a-s. Perfor… | 1993 |
| * | K925779 | Branemark System Titanium Healing AbutmentsSummary page 1…ems (K041655) & K971706) Branemark Systems (K925777, K925779, K961728, device 1a-s. Performance… | 1993 |
| * | K961728 | Miruscone Abutment SystemSummary page 1…655) & K971706) Branemark Systems (K925777, K925779, K961728, device 1a-s. Performance… | 1996 |
| * | K971706 | Tiadapt Abutment SystemSummary page 1…umber: 872.3640 10-7. Predicate Devices BIOPLANT Implant Systems (K041655) & K971706) Branemark Systems (K925777, K925779, K961728,… | 1997 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071148 | Atlas Implant System | 2008 | 4 |
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 10 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 5 of the 52 ancestors have a recall of any class.
- Of its descendants, K071148 (Cowellmedi Co., Ltd., 2008) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K041655.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Allfim Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Allfim Implant Systems (Atlas Fixtures and Atlas Shoulder Abutments) consists of two-stage, root-form dental implants, associated abutment systems, which provide the clinician with cement-retained, screw-retained and overdenture-type restorative options. The devices covered by this submission…
Read the full statement (96 words)
Allfim Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients.
Allfim Implant Systems (Atlas Fixtures and Atlas Shoulder Abutments) consists of two-stage, root-form dental implants, associated abutment systems, which provide the clinician with cement-retained, screw-retained and overdenture-type restorative options.
The devices covered by this submission are Atlas Fixtures, and Atlas Shoulder Abutments which are placed into dental implant to provide support for prosthetic reconstruction.
The non-hexa-shoulder abutment is designed for single crown use only. The hexa-shoulder abutment is designed for bridge use only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050635: Allfim Implant Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050635
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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