510(k) · Cleared
ClearedPanthera Dental Milled Bars
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Panthera Dental, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Apr 8, 2020 as substantially equivalent to K173466 (Panthera Dental, Inc., 2018) after a 247-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Apr 8, 2020
- Review
- 247 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K944964 (1995). 23 ancestors in all, the oldest K910611 (1991). No later device cites it as a predicate yet.
- Root · 8 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 7 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 6 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 5 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 4 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 3 generations backK034035 3I Patient-Specific Overdenture BarImplant Innovations, Inc. · 2004
- 2 generations backK080864 Cam Structsure Precision Milled BarsBiomet 3i, Inc. · 2008
- 1 generation backK173466 Panthera Dental Milled BarsPanthera Dental, Inc. · 2018
- This deviceK192108 Panthera Dental Milled BarsPanthera Dental, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −7 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −6 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −5 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −4 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −3 | K034035 | 3I Patient-Specific Overdenture Bar | Implant Innovations, Inc. | 2004 | — |
| −2 | K080864 | Cam Structsure Precision Milled Bars | Biomet 3i, Inc. | 2008 | — |
| −1 | K173466 | Panthera Dental Milled Bars | Panthera Dental, Inc. | 2018 | — |
| 0 (this device) | K192108 | Panthera Dental Milled Bars | Panthera Dental, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 8 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 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? (1)
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 |
|---|---|---|---|
| * | K173466 | Panthera Dental Milled BarsSummary page 4…Common Name: Overdenture Bar Classification: 21 CFR 872.3630 (Class II) Product Code: NHA Primary Predicate: K173466 Panthera Dental Milled Bars Reference Devices: K071370, K133731 NobelActive K173418… | 2018 |
| † | K071370 | Nobelactive Internal Connection Implant | 2007 |
| † | K133731 | Nobelactive Wide Platform (WP) | 2014 |
| † | K173418 | NobelParallel Conical Connection | 2019 |
| † | K062566 | Nobelreplace Tapered Conical Connection | 2006 |
| † | K073142 | Nobelreplace Hexagonal Implant | 2008 |
| † | K023113 | Replace Tiunite Endosseous Implant | 2002 |
| † | K050406 | Nobelspeedy Implants | 2005 |
| † | K160119 | NobelSpeedy Groovy | 2016 |
| † | K022562 | Various Branemark System Implants-Immediate Function Indication | 2002 |
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 25 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 23 ancestors has a recall of any class.
- 1 other device also cites its predicate K173466.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The Panthera Dental Milled Bar is indicated for use as an accessory to an endosseous dental implant to support a
prosthetic device in a partially or edentulous patient for purpose of restoring chewing function. It is intended for use to
support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.
The Panthera Dental Milled Bars are indicated for compatibility with:
» NobelActive: NP @3.5; RP 04.3 / @5.0; WP 05.5
» NobelParallel CC: NP ©03.75; RP @4.3 / @5.0; WP @5.5
* NobelReplace: NP 033.5; RP 04.0 / ¥4.3 / ©5.0; WP 05.0; 6 06.0
* NobelSpeedy: RP ©4.0 / ©5.0; WP ©5.0 / ©6.0
» Branemark: NP ?3.3; RP ©@3.75 / @4.0; WP ©@5.0
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192108: Panthera Dental Milled Bars.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192108
Report an extraction error
Are you the manufacturer?
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