510(k) · Cleared
ClearedZirace
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acucera, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Oct 19, 2005 as substantially equivalent to K042658 (Nobel Biocare Uas, Inc., 2004) and 5 other predicates after a 135-day review. Its family tree reaches back 7 generations to 1995. 8 later devices descend from it.
- Decided
- Oct 19, 2005
- Review
- 135 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 7 generations to K944964 (1995). 42 ancestors in all, the oldest K871863 (1987). 8 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 6 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 5 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 4 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 3 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 2 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 1 generation backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- This deviceK051501 ZiraceAcucera, Inc. · 2005
- Descendant · cites it directly · 7 of its ownK063494 Doro Radiolucent Headrest System ( Also Mri-Compatible) and ComponentsPro-Med Instruments GmbH · 2007
- Descendant · 2 generations on · 4 of its ownK072208 Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation · 2007
- Descendant · 2 generations on · 2 of its ownK103493 Head Fiation Device (HFD 100)Imris, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK191740 DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH · 2020
- Descendant · 3 generations on · 0 of its ownK250423 mb-FIX Cranial Stabilization SystemsMedical Bees GmbH · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K063494Doro Radiolucent Headrest System ( Also Mri-Compatible) and ComponentsPro-Med Instruments GmbH · 2007 · cites it directly7descendants
- K072208Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation · 2007 · 2 generations on4descendants
- K103493Head Fiation Device (HFD 100)Imris, Inc. · 2011 · 2 generations on2descendants
- K191740DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH · 2020 · 2 generations on1descendant
- K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbH · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −6 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −5 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −4 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −3 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −2 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −1 | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… | Nobel Biocare Uas, Inc. | 2004 | — |
| 0 (this device) | K051501 | Zirace | Acucera, Inc. | 2005 | — |
| +1 | K063494 | Doro Radiolucent Headrest System ( Also Mri-Compatible) and Components | Pro-Med Instruments GmbH | 2007 | — |
| +2 | K072208 | Mayfield Disposable and Reusable Titanium Skull Pins | Integra LifeSciences Corporation | 2007 | — |
| +2 | K103493 | Head Fiation Device (HFD 100) | Imris, Inc. | 2011 | 3 |
| +2 | K191740 | DORO LUCENT® iXI and iMRI Headrest System | Pro Med Instruments GmbH | 2020 | — |
| +3 | K250423 | mb-FIX Cranial Stabilization Systems | Medical Bees GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 8 | 0 |
| 1994 | 8 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Summary page 1…ue, for ready visualization. VIL. Substantial lquivalence: Air Ace [L t is substantially equivalent, and nearly identical, to the Procera Abutment Branemark. cleared in K042658. It is equivalent to several other ceramic abutments, such as the Esthetic Zirconia Abutment (K031719), the Astra Tech Dental Inp… | 2004 |
| * | K031719 | Esthetic Zirconia AbutmentSummary page 1…and nearly identical, to the Procera Abutment Branemark. cleared in K042658. It is equivalent to several other ceramic abutments, such as the Esthetic Zirconia Abutment (K031719), the Astra Tech Dental Inplants--Ceramnic abutment (K023631) and others such as the Ceramic Abutment (K9132255), the Procera Abt… | 2003 |
| * | K023631 | Astra Tech Dental Implants-Ceramic AbutmentsSummary page 1…red in K042658. It is equivalent to several other ceramic abutments, such as the Esthetic Zirconia Abutment (K031719), the Astra Tech Dental Inplants--Ceramnic abutment (K023631) and others such as the Ceramic Abutment (K9132255), the Procera Abtutment System (K974150), the 3i 1)ental Abutment (K032263), a… | 2002 |
| * | K913255 | Ceramic (TM) Abutment | 1994 |
| * | K974150 | Procera Preparable Abutment SystemSummary page 1…irconia Abutment (K031719), the Astra Tech Dental Inplants--Ceramnic abutment (K023631) and others such as the Ceramic Abutment (K9132255), the Procera Abtutment System (K974150), the 3i 1)ental Abutment (K032263), and the Sterngold ImplamMed I lex Implant (KO81516). [he material firom which the Zir Ace'FN… | 1998 |
| * | K032263 | 3I Patient-Specific Dental Abutment and Overdenture BarSummary page 1…ra Tech Dental Inplants--Ceramnic abutment (K023631) and others such as the Ceramic Abutment (K9132255), the Procera Abtutment System (K974150), the 3i 1)ental Abutment (K032263), and the Sterngold ImplamMed I lex Implant (KO81516). [he material firom which the Zir Ace'FN4 abutment is manufhctured is equiv… | 2004 |
| Kept off the family tree | K081516 | FDA’s K081516 is Medsource CPR Mask with & Without Oxygen Port Our reading of the summary gave K081516, which FDA decided on Aug 26, 2008, after this device was decided (Oct 19, 2005), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. | 2008 |
| † | K971414 | Zirconia Prozyr Ceramic 12/14 Global Taper (GT) Femoral Heads | 1997 |
| † | K033227 | Luxaform Plus | 2004 |
| † | K043472 | Medin Tech Zirconia-CP10, SS1000 | 2005 |
| † | K984201 | Denzir | 1999 |
| † | K023327 | Cynovad Zirkon | 2002 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063494 | Doro Radiolucent Headrest System ( Also Mri-Compatible) and Components | 2007 | 7 |
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 4 companies; a new generation was cleared every 10 months on median.
- 5 of the 42 ancestors have a recall of any class.
- Of its descendants, K063494 (Pro-Med Instruments GmbH, 2007) has gone furthest, with 7 descendants of its own.
- 9 other devices also cite its predicate K042658.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
ZirAce IM abutments are indicated for use in partially edentulous patients requiring prosthetic devices and/or endosseous implants to restore chewing function. They are especially applicable to anterior or canine teeth where the typical titanium color may show through the gum. In addition to the Branemark (Nobel Biocare) implants, the ZirAce IM abutments hexagon connector fits the external hexagon of the following implants:
Lifecore Biomedical,
Sterngold Implamed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051501 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051501: Zirace.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051501
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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