510(k) · Cleared
ClearedTDS Precision Dental Bar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pou YU Biotechnology Co., Ltd. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Oct 5, 2010 as substantially equivalent to K080864 (Biomet 3i, Inc., 2008) and 2 other predicates after a 235-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Oct 5, 2010
- Review
- 235 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K944964 (1995). 66 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 5 generations between
- 3 generations backK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- 2 generations backK053091 Procera Implant Bridge ZirconiaNobel Biocare AB · 2006
- 1 generation backK091907 Nobelprocera Implant Bridge ZirconiaNobel Biocare AB · 2009
- This deviceK100356 TDS Precision Dental BarPou YU Biotechnology Co., Ltd. · 2010
Show all 9 generations
- Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 8 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 7 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 6 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 5 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 4 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 3 generations backK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004
- 2 generations backK053091 Procera Implant Bridge ZirconiaNobel Biocare AB · 2006
- 1 generation backK091907 Nobelprocera Implant Bridge ZirconiaNobel Biocare AB · 2009
- This deviceK100356 TDS Precision Dental BarPou YU Biotechnology Co., Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −8 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −7 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −6 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −5 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −4 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −3 | K043042 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | Nobel Biocare AB | 2004 | — |
| −2 | K053091 | Procera Implant Bridge Zirconia | Nobel Biocare AB | 2006 | — |
| −1 | K091907 | Nobelprocera Implant Bridge Zirconia | Nobel Biocare AB | 2009 | — |
| 0 (this device) | K100356 | TDS Precision Dental Bar | Pou YU Biotechnology Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 9 | 0 |
| 1994 | 9 | 0 |
| 1995 | 6 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 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? (3)
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 |
|---|---|---|---|
| * | K080864 | Cam Structsure Precision Milled BarsSummary page 1…Class II, 21 CFR 872.3630 Product Code: NHA LEGALLY MARKETED DEVICES BIOMET 3i, Incorporated. - CAM StructSURE(O) Precision Milled Bars - K080864 Cagenix, Incorporated. - Accuframe TM - K(081157 Nobel Biocare USA LLC. - NobelProcera Implant Bridge Zirconia - K(09 1907 DES… | 2008 |
| * | K081157 | AccuframeSummary page 1…NHA LEGALLY MARKETED DEVICES BIOMET 3i, Incorporated. - CAM StructSURE(O) Precision Milled Bars - K080864 Cagenix, Incorporated. - Accuframe TM - K(081157 Nobel Biocare USA LLC. - NobelProcera Implant Bridge Zirconia - K(09 1907 DESCRIPTION OF THE DEVICE TDS Precision Dental Bars… | 2008 |
| * | K091907 | Nobelprocera Implant Bridge Zirconia | 2009 |
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 15 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 8 of the 66 ancestors have a recall of any class.
- 2 other devices also cite its predicate K080864.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
TDS Precision Dental Bars are indicated for use with dental implants as a prosthetic framework to support and/or retain removable or fixed dental prostheses in the treatment of partially or totally edentulous jaws to restore chewing function. The abutment screws are intended to secure the bar to the endosseous implants. TDS Titanium Precision Dental Bars, made of machined titanium material, are compatible with following implant systems: Implant brand —…
Read the full statement (418 words)
TDS Precision Dental Bars are indicated for use with dental implants as a prosthetic framework to support and/or retain removable or fixed dental prostheses in the treatment of partially or totally edentulous jaws to restore chewing function. The abutment screws are intended to secure the bar to the endosseous implants.
TDS Titanium Precision Dental Bars, made of machined titanium material, are compatible with following implant systems:
Implant brand — Model
NobelBiocare — Branemark - NP, RP, WP; Replace - NP, RP, WP, 6.0 mm; NobelActive - NP, RP
Camlog — 3.8, 4.3, 5.0, 6.0 mm
BIOMET 3i — External - 3.4, 4.1, 5.0, 6.0 mm; Certain - 3.4, 4.1, 5.0, 6.0 mm
Zimmer — Tapered Screw-vent - 3.5, 4.5, 5.7 mm
Lifecore — External Hex - SD, RD, WD; Internal Hex - SDI 3.75, RDI 4.5/4.75 mm
Astra — OsseoSpeed - 3.5/4.0, 4.5/5.0 mm
Biol-orizons — External - 3.5, 4.0, 5.0, 6.0 mm; Internal - 3.5, 4.5, 5.7 mm
Straumann — NN, RN, WN; Bone Level - NC 3.3, RC 4.1, RC 4.8 mm
Dentsply Friadent — XiVE - 3.0 mm; Frialit(XiVE) - 3.4, 3.8, 4.5, 5.5 mm; Frialit - 6.5 mm
Osstem — GS - Mini, Standard; SS - Regular, Wide; US - Mini, Regular, Wide
TDS Zirconia Precision Dental Bars, made of machined zirconia material, are compatible with following implant systems:
Implant brand — Model
NobelBiocare — Branemark - NP, RP, WP
BIOMET 3i — External - 3.4, 4.1, 5.0, 6.0 mm
Lifecore — External Hex - SD, RD, WD
Biol-orizons — External - 3.5, 4.0, 5.0, 6.0 mm
TDS Hybrid Precision Dental Bars, made of machined zirconia-titanium materials, are compatible with following implant systems:
Implant brand — Model
NobelBiocare — Replace - NP, RP, WP, 6.0 mm; NobelActive - NP, RP
Camlog — 3.8, 4.3, 5.0, 6.0 mm
BIOMET 3i — Certain - 3.4, 4.1, 5.0, 6.0 mm
Zimmer — Tapered Screw-vent - 3.5, 4.5, 5.7 mm
Lifecore — Internal Hex - SDI 3.75, RDI 4.5/4.75 mm
Astra — OsseoSpeed - 3.5/4.0, 4.5/5.0 mm
Biol-orizons — Internal - 3.5, 4.5, 5.7 mm
Straumann — RN, WN; Bone Level - NC 3.3, RC 4.1, RC 4.8 mm
Dentsply Friadent — XiVE - 3.0 mm; Frialit(XiVE) - 3.4, 3.8, 4.5, 5.5 mm; Frialit - 6.5 mm
Osstem — GS - Mini, Standard; SS - Regular, Wide
Note: Highly angled abutments (i.e. 300) on implants with diameters less than 4 mm are not intended for the posterior region of the mouth due to limited strength of the implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100356: TDS Precision Dental Bar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100356
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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