510(k) · Cleared
ClearedUniversal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw
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 Aug 6, 2026 as substantially equivalent to K200040 (Nobel Biocare AG, 2020) and 6 other predicates after a 234-day review. Its family tree reaches back 15 generations to 1990.
- Decided
- Aug 6, 2026
- Review
- 234 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 15 generations to K894595 (1990). 105 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations between
- 3 generations backK202344 TiUltra Implants and Xeal AbutmentsNobel Biocare AB · 2020
- 2 generations backK211109 N1 TiUltra TCC Implant SystemNobel Biocare Services AG · 2021 · Recalled
- 1 generation backK220048 NobelProcera Zirconia N1 BaseNobel Biocare Services AG · 2022
- This deviceK253999 Universal Base ASC Engaging; Universal Base ASC Non-Engaging…Nobel Biocare AB · 2026
Show all 15 generations
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 14 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 13 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 12 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 11 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 10 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 9 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 8 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 7 generations backK083205 Nobelactive 8.5 MM & 18.0 MMNobel Biocare AB · 2009
- 6 generations backK133731 Nobelactive Wide Platform (WP)Nobel Biocare AB · 2014
- 5 generations backK142260 NobelActiveNobel Biocare AB · 2015
- 4 generations backK173418 NobelParallel Conical ConnectionNobel Biocare AB · 2019 · Recalled
- 3 generations backK202344 TiUltra Implants and Xeal AbutmentsNobel Biocare AB · 2020
- 2 generations backK211109 N1 TiUltra TCC Implant SystemNobel Biocare Services AG · 2021 · Recalled
- 1 generation backK220048 NobelProcera Zirconia N1 BaseNobel Biocare Services AG · 2022
- This deviceK253999 Universal Base ASC Engaging; Universal Base ASC Non-Engaging…Nobel Biocare AB · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −14 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −13 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −12 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −11 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −10 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −9 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −8 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −7 | K083205 | Nobelactive 8.5 MM & 18.0 MM | Nobel Biocare AB | 2009 | — |
| −6 | K133731 | Nobelactive Wide Platform (WP) | Nobel Biocare AB | 2014 | — |
| −5 | K142260 | NobelActive | Nobel Biocare AB | 2015 | — |
| −4 | K173418 | NobelParallel Conical Connection | Nobel Biocare AB | 2019 | 1 |
| −3 | K202344 | TiUltra Implants and Xeal Abutments | Nobel Biocare AB | 2020 | — |
| −2 | K211109 | N1 TiUltra TCC Implant System | Nobel Biocare Services AG | 2021 | 2 |
| −1 | K220048 | NobelProcera Zirconia N1 Base | Nobel Biocare Services AG | 2022 | — |
| 0 (this device) | K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base… | Nobel Biocare AB | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 10 | 0 |
| 1994 | 10 | 0 |
| 1995 | 7 | 0 |
| 1996 | 10 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2024 | 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 30.7 · 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 |
|---|---|---|---|
| * | K200040 | Universal Base Conical Connection (CC)Summary page 8…Dental Implant Abutment Regulation Number: 21 CFR 872.3630 Device Class: II Product Code: NHA 1.9 Predicate Device Primary Predicate K200040 Universal Base Conical Connection, Nobel Biocare Reference Devices 1 K233208 NobelPr… | 2020 |
| * | K211109 | N1 TiUltra TCC Implant SystemSummary page 9…K240982 DESS® Dental Smart Solutions, Terrats Medical SL N1 Base Xeal + Universal Abutment N1 Base Tri Bridge, 3 K211109 Nobel Biocare Elos Accurate Hybrid Base (Universal Base non-engagin… | 2021 |
| * | K102436 | Nobel Active 3.0Summary page 9…Biocare Temporary Snap Abutment (Engaging and Non-Engaging), 6 K161435 Nobel Biocare K102436, 7 Healing Abutment Conical Connection, Nobel Biocare K133731 8 K233208… | 2010 |
| * | K133731 | Nobelactive Wide Platform (WP)Summary page 9…K161435 Nobel Biocare K102436, 7 Healing Abutment Conical Connection, Nobel Biocare K133731 8 K233208 Omnigrip Clinical Screw Titanium, Nobel Biocare Clinical Screw Mult… | 2014 |
| * | K233208 | NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumSummary page 9…NHA 1.9 Predicate Device Primary Predicate K200040 Universal Base Conical Connection, Nobel Biocare Reference Devices 1 K233208 NobelProcera Titanium Abutment ASC, Nobel Biocare 2 K240982 DESS® Dental Smart Solutions, Te… | 2024 |
| * | K220048 | NobelProcera Zirconia N1 BaseSummary page 9…N1 TCC, 9 K211109 Nobel Biocare Prosthetic Screw NobelProcera Zr Nobel Biocare N1 Base, 10 K220048 Nobel Biocare 11 K202452 Prosthetic Screw MUA Omnigrip Mini, Nobel Biocare 1… | 2022 |
| * | K202452 | NobelProcera Zirconia Implant BridgeSummary page 9…Biocare Prosthetic Screw NobelProcera Zr Nobel Biocare N1 Base, 10 K220048 Nobel Biocare 11 K202452 Prosthetic Screw MUA Omnigrip Mini, Nobel Biocare 1.10 Device Description Summary The subject device Universal Base… | 2020 |
| † | K240982 | DESS Dental Smart Solutions | 2024 |
| † | K201860 | Elos Accurate Hybrid Base | 2021 |
| † | K161435 | Temporary Snap Abutment | 2016 |
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 36 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 17 of the 105 ancestors have a recall of any class.
- 1 other device also cites its predicate K200040.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Universal Bases ASC Engaging are indicated to support the placement of single unit, screw retained prosthetic restorations in the maxilla or mandible. The Universal Base consists of two major parts. Specifically, the titanium base and mesostructured components make up a two-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from intra oral scanners, CAD software, CAM software, ceramic and…
Read the full statement (427 words)
Universal Bases ASC Engaging are indicated to support the placement of single unit, screw retained prosthetic restorations in the maxilla or mandible.
The Universal Base consists of two major parts. Specifically, the titanium base and mesostructured components make up a two-piece abutment.
The system integrates multiple components of the digital dentistry workflow: scan files from intra oral scanners, CAD software, CAM software, ceramic and ceramic-dominant material, milling machine and associated tooling and accessories.
Universal Bases ASC Non-Engaging are indicated to support the placement of multiple unit, screw retained prosthetic restorations in the maxilla or mandible.
The Universal Base Non-Engaging consists of multiple parts. Specifically, the titanium base and multi-unit mesostructure components make up a multi-piece abutment.
The system integrates multiple components of the digital dentistry workflow: scan files from intra oral scanners, CAD software, CAM software, ceramic and ceramic-dominant material, milling machine and associated tooling and accessories.
Universal Bases MUA ASC:
Universal Base MUA ASC are indicated to support the placement of multiple unit, screw retained prosthetic restorations in the maxilla or mandible.
The Universal Base MUA consists of three major parts, specifically the Multi-unit abutment, the Universal Base MUA and the mesostructure components make up a multi-piece abutment.
The system integrates multiple components of the digital dentistry workflow: scan files from intra oral scanners, CAD software, CAM software, ceramic and ceramic-dominant material, milling machine and associated tooling and accessories.
Temporary Abutment Engaging and Non-Engaging:
Temporary Abutments Engaging CC are indicated for use with single unit screw-retained temporary dental prostheses placed on endosseous dental implants in the maxilla and mandible, for up to 180 days.
Temporary Abutment Non-Engaging CC are indicated for use with multiple unit screw-retained temporary dental prosthesis placed on endosseous dental implant in the maxilla and mandible, for up to 180 days, for implants with less than 14 ° overall divergences to allow path of insertion.
Omnigrip Clinical Screw Titanium:
Clinical Screws are indicated for use to secure a dental abutment or framework to a dental implant in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation.
Omnigrip Prosthetic Screw:
Prosthetic screws are indicated for use to secure a dental abutment or framework to a dental abutment or base in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation.
Healing Abutment Conical Connection:
The Healing Abutments Conical Connection are premanufactured prosthetic components to be directly connected to the endosseous dental implants or abutments and are indicated as temporary components for one single tooth to full arch denture procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253999 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253999: Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253999
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026