# K100356: TDS Precision Dental Bar

- Pathway: 510(k) (Traditional)
- Applicant: Pou YU Biotechnology Co., Ltd.
- Decided: Oct 5, 2010 after 235 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K944964 (1995). 66 ancestors in all.
No later device cites it as a predicate yet.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080864: Cam Structsure Precision Milled Bars, Biomet 3i, Inc. (2008) Summary page 1.
- K081157: Accuframe, Cagenix, Inc. (2008) Summary page 1.
- K091907: Nobelprocera Implant Bridge Zirconia, Nobel Biocare AB (2009)

## Indications for use
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.

Source page: https://510kreport.com/device/K100356
Methodology: https://510kreport.com/methodology