510(k) · Cleared
ClearedProcera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare AB · NHA Abutment, Implant, Dental, Endosseous
Cleared on May 26, 2004 as substantially equivalent to K023113 (Nobel Biocare Uas, Inc., 2002) and 3 other predicates after a 15-day review. Its family tree reaches back 5 generations to 1990. 328 later devices descend from it.
- Decided
- May 26, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K894844 (1990). 21 ancestors in all. 328 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 4 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 3 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 2 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 1 generation backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- This deviceK041236 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- Descendant · cites it directly · 327 of its ownK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- Descendant · cites it directly · 313 of its ownK090069 Procera Implant Bridge OverdentureNobel Biocare AB · 2009
- Descendant · 2 generations on · 278 of its ownK091756 Nobelprocera TI AbutmentNobel Biocare AB · 2009
- Descendant · 3 generations on · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
- Descendant · cites it directly · 167 of its ownK101465 Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010
Showing 5 of 328 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 328 · See all- K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004 · cites it directly327descendants
- K090069Procera Implant Bridge OverdentureNobel Biocare AB · 2009 · cites it directly313descendants
- K091756Nobelprocera TI AbutmentNobel Biocare AB · 2009 · 2 generations on278descendants
- K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · 3 generations on240descendants
- K101465Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG · 2010 · cites it directly167descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −4 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −3 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −2 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −1 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| 0 (this device) | K041236 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | Nobel Biocare AB | 2004 | — |
| +1 | K043042 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | Nobel Biocare AB | 2004 | — |
| +1 | K090069 | Procera Implant Bridge Overdenture | Nobel Biocare AB | 2009 | — |
| +2 | K091756 | Nobelprocera TI Abutment | Nobel Biocare AB | 2009 | — |
| +3 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
| +1 | K101465 | Straumann Cares Bridge; Straumann Cares Dolder Bar | Institut Straumann AG | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 5 | 0 |
| 2014 | 14 | 0 |
| 2015 | 15 | 0 |
| 2016 | 19 | 0 |
| 2017 | 17 | 0 |
| 2018 | 16 | 0 |
| 2019 | 17 | 0 |
| 2020 | 30 | 0 |
| 2021 | 27 | 0 |
| 2022 | 25 | 0 |
| 2023 | 33 | 0 |
| 2024 | 41 | 0 |
| 2025 | 29 | 0 |
| 2026 | 17 | 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 |
|---|---|---|---|
| * | K023113 | Replace Tiunite Endosseous ImplantSummary page 1…rade or Proprietary or Model Name: Procera® Implant Bridge Legally Marketed Devices: Nobel Biocare - Replace TiUnite Endosseous Implant (K023113) Nobel Biocare - Branemark System Implants (K022562) St… | 2002 |
| * | K022562 | Various Branemark System Implants-Immediate Function IndicationSummary page 1…Marketed Devices: Nobel Biocare - Replace TiUnite Endosseous Implant (K023113) Nobel Biocare - Branemark System Implants (K022562) Steri-Oss - Steri-Oss Implants for Single Stage Placement (K963224)… | 2002 |
| * | K963224 | Steri-Oss Implants for Single Stage PlacementSummary page 1…Nobel Biocare - Branemark System Implants (K022562) Steri-Oss - Steri-Oss Implants for Single Stage Placement (K963224) Straumann - ITI synOcta Meso Abutments (K033243) Device Description: Nobel Biocare's Proce… | 1996 |
| * | K033243 | Iti Synocta Meso AbutmentsSummary page 1…Steri-Oss - Steri-Oss Implants for Single Stage Placement (K963224) Straumann - ITI synOcta Meso Abutments (K033243) Device Description: Nobel Biocare's Procera ® Implant Bridge is a bridge framework that attaches to implants or abutments. The… | 2003 |
What descends from it? (328)
See all 3284 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 14 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K043042 (Nobel Biocare AB, 2004) has gone furthest, with 327 descendants of its own.
- 16 other devices also cite its predicate K023113.
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?
The Procera Implant Bridge is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The Procera Implant Bridge can be used at the implant or abutment level of the following implant systems: -Nobel Biocare Brinemark System -Nobel Biocare Replace Select The Procera Implant Bridge can be used at the implant level of the following implant systems: -Nobel Biocare Replace…
Read the full statement (116 words)
The Procera Implant Bridge is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
The Procera Implant Bridge can be used at the implant or abutment level of the following implant systems:
-Nobel Biocare Brinemark System
-Nobel Biocare Replace Select
The Procera Implant Bridge can be used at the implant level of the following implant systems:
-Nobel Biocare Replace
-Nobel Biocare Sten-Oss HL
-Nobel Biocare Novum
*Straumann Dental Implant System Regular neck 4.8
*Straumann Dental Implant System Wide neck 6.5
The Procera Implant Bridge can be used at abutment level of the following implant systems:
-Nobel Biocare ARK abutment for Teeth-in-Hour concept
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041236 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041236: Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041236
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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