TDS PRECISION DENTAL BAR

K100356 · Pou YU Biotechnology Co., Ltd. · NHA · Oct 5, 2010 · Dental

Device Facts

• Record ID: K100356
• Device Name: TDS PRECISION DENTAL BAR
• Applicant: Pou YU Biotechnology Co., Ltd.
• Product Code: NHA · Dental
• Decision Date: Oct 5, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

TDS Precision Dental Bars are custom-fabricated prosthetic frameworks; machined from titanium, zirconia, or zirconia-titanium; secured to endosseous dental implants via Ti-6Al-4V ELI alloy screws. Device serves as support/retention structure for fixed or removable dental prostheses. Used in clinical dental settings; operated by dental professionals. Compatibility spans multiple major implant systems (e.g., NobelBiocare, Straumann, Zimmer). Output is a physical framework restoring patient chewing function.

Clinical Evidence

Bench testing only. Mechanical fatigue testing performed per ISO 14801 on worst-case construction (angled abutment) to verify strength. Compatibility testing conducted to evaluate dimensions, tolerances, and rotation parameters for fit with designated implant systems.

Technological Characteristics

Materials: Machined titanium, zirconia, and zirconia-titanium. Abutment screws: Ti-6Al-4V ELI alloy. Design: Custom-fabricated prosthetic framework. Compatibility: Multi-brand dental implant systems. Testing: ISO 14801 fatigue testing. No software or electronic components.

Indications for Use

Indicated for partially or totally edentulous patients requiring prosthetic frameworks to support/retain fixed or removable dental prostheses. Contraindicated for highly angled abutments (30°) on implants <4 mm diameter in the posterior region due to limited implant strength.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Predicate Devices

• CAM StructSURE Precision Milled Bars (K080864)
• Accuframe TM (K081157)
• NobelProcera Implant Bridge Zirconia (K091907)

Submission Summary (Full Text)

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K10035p

# 510(k) Summary Pou Yu Biotechnology Co., Ltd TDS Precision Dental Bar

- ﺗﺸﺘﻪ

OCT - 5 2010

#### APPLICANT'S NAME AND ADDRESS

| Applicant's Name: | |
|-------------------|--|
| Address: | |

| Telephone: |
|-----------------|
| Fax: |
| Contact person: |
| Date Prepared: |

Pou Yu Biotechnology Co., Ltd. No. 6 Fugong Rd. Fusing Township Changhua County 506, Taiwan [phone] x5122 [phone] Daniel Tsao February 2, 2010

#### NAME OF THE DEVICE

| Trade/Proprietary Name: | TDS Precision Dental Bar |
|-------------------------|------------------------------------|
| Common Name: | Dental implant bar |
| Classification Name: | Endosseous dental implant abutment |
| | Class II, 21 CFR 872.3630 |
| Product Code: | NHA |

#### LEGALLY MARKETED DEVICES

BIOMET 3i , Incorporated. - CAM StructSURE® Precision Milled Bars - K080864 Cagenix, Incorporated. - Accuframe TM - K081157 Nobel Biocare USA LLC. - NobelProcera Implant Bridge Zirconia - K091907

### DESCRIPTION OF THE DEVICE

TDS Precision Dental Bars are prosthetic frameworks and made of machined titanium, zirconia-titanium, and zirconia materials. They are connected with dental implants utilizing the TDS screw which is made of Ti-6A1-4V ELI (Extra Low Interstitial) alloy. TDS Precision Dental Bars are

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fabricated individually following instructions to each patient and serve to support and/or retain fixed dental prosthesis or removable dental prosthesis. They are compatible with dental implants manufactured by NobelBiocare, Camlog, BIOMET 3i, Zimmer, Lifecore, Astra, BioHorizons, Straumann, Dentsply Friadent, and Osstem.

## INTENDED USE OF THE DEVICE

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.

| 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 |
| BioHorizons | 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 Titanium Precision Dental Bars, made of machined titanium material, are compatible with following implant systems:

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 |
| BioHorizons | External - 3.5, 4.0, 5.0, 6.0 mm |
| Straumann | NN |
| Osstem | US - Mini, Regular, Wide |

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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 |
| BioHorizons | 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. 30°) 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.

#### TECHNOLOGICAL CHARACTERISTICS

The TDS Precision Dental Bar has the following similarities to the predicate devices which have been determined by FDA:

- · has the same intended use,
- · uses the same operating principle,
- · incorporates the same basic design,
- · incorporates the same materials, and
- · is produced using the same processes.

#### NON-CLINICAL TESTING DATA

Mechanical testing, according to ISO 14801 Dentistry - Fatigue test for endosseous dental implants, was conducted on a worst-case scenario with construction of an angle abutment to ensure that the strength of the abutment for TDS Precision Dental Bar is appropriate for its intended use. Compatibility testing was conducted on the abutments and corresponding dental implants with designated screws, the dimensions, tolerances and rotation parameters were evaluated in determining

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appropriate fit.

These testing results show that TDS Precision Dental Bar made of titanium, zirconia-titanium and zirconia materials for their respective dental implant systems have sufficient mechanical strength for their intended clinical application and are compatible with the implant systems for which they are indicated for use.

### BASIS FOR SUBSTANTIAL EQUIVALENCE

Pou Yu Biotechnology Co. Ltd demonstrated that, for the purposes of FDA's regulation of medical devices, TDS Precision Dental Bar is substantially equivalent in intended use, materials, design principles and produced processes to predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices.

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Image /page/4/Picture/1 description: The image shows a logo for the Department of Health & Human Services USA. The logo features a stylized eagle or bird symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Daniel Tsao Manager Pou Yu Biotechnology Company, Limited No. 6 Fugong Road Fusing Township, Changhua City CHINA (Taiwan) 506

OCT - 5 2010

Re: K100356

Trade/Device Name: TDS Precision Dental Bar Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 3, 2010 Received: September 9, 2010

Dear Mr. Tsao:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Tsao

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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## Indications for Use

510(k) Number (if known): 1100356

Device Name: TDS Precision Dental Bar

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 |
| BioHorizons | 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 |
| BioHorizons | External - 3.5, 4.0, 5.0, 6.0 mm |
| Straumann | NN |
| Osstem | US - Mini, Regular, Wide |

OCT - 5 2010

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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 |
| BioHorizons | 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. 30°) 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evatuation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
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510(k) Number: K100354