(136 days)
No
The device description and performance studies focus on the mechanical properties and compatibility of a physical dental abutment, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device acts as a support structure for prostheses, which is a restorative function, not a therapeutic one. Therapeutic devices are typically involved in treating or curing diseases or conditions.
No
Explanation: The device description and intended use clearly state that the TDS Abutment is a support for prostheses used with dental implants. It is a structural component designed for restorative purposes, not for diagnosing an illness or condition. The performance studies focus on mechanical strength and compatibility, further confirming its non-diagnostic nature.
No
The device description explicitly states that the device is made of titanium and ceramic-titanium, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a support for dental prostheses in the maxilla or mandible of a patient. This is a direct clinical application within the body.
- Device Description: The description details the materials and function of the abutment as a component used in conjunction with dental implants to support restorations. This is a mechanical device for surgical and prosthetic use.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is implanted within the body to support dental work.
N/A
Intended Use / Indications for Use
TDS Abutment for Friadent Xive is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
This device is compatible with the following implant systems which have an internal hex with flat-to-flat dimensions of 1.78mm or greater: Firadent: FRIALIT Implant, XiVA Implant; 3i: Internal Connect Type; Astra: Osseospeed Implant, Osseospeed TX Implant; BioHorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System, Laser-lok® 3.0 implant system; Lifecore: Lifecore RENOVA™ Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System; Osstem: GS System; Nobel Biocare: Active Implant.
Product codes
NHA
Device Description
TDS Abutment for Friadent Xive are titanium and ceramic-titanium abutments designed to be used in conjunction with specific dental implants utilizing the TDS Abutment screw, which is made of Ti-6A1-4V ELI titanium and is used to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Abutment for Friadent Xive is compatible with the following implant systems which have an internal hex with flat-to-flat dimensions of 1.78mm or greater: Firadent: FRIALIT Implant, XiVA Implant; 3i: Internal Connect Type; Astra: Osseospeed Implant, Osseospeed TX Implant; BirHorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System, Laser-lok 3.0 implant system; Lifecore: Lifecore RENOVA™ Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System; Osstem: GS System; Nobel Biocare: Active Impalnt.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 TDS Abutment for Friadent Xive 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 appropriate fit. These testing results show that TDS Abutment for Friadent Xive 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
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.(b)
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.)
0
510(k) Summary Pou Yu Biotechnology Co., Ltd TDS Abutment for Friadent Xive
APPLICANT'S NAME AND ADDRESS
Applicant' Name: Address:
Telephone: Fax: Official Contact: Date Prepared:
Pou Yu Biotechnology Co., Ltd. No. 6 Fugong Rd. Fusing Township Changhua County 506, Taiwan +886-(0)4 768 5660 x5122 +886-(0)4 768 9032 Daniel Tsao November 5, 2010
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name: Classification Regulations:
Product Code: Classification Panel: Reviewing Branch:
TDS Abutment for Friadent Xive, Dental implant abutment Endosseous dental implant abutment Class II, 21 CFR 872.3630 NHA Dental Products Panel Dental Devices Branch
LEGALLY MARKETED DEVICES
FRIADENT GmbH. – Xive TG Abutments –K032302 Lifecore Biomedical Inc. - PrimaConnex® CAD/CAM Abutment System- K072241 Atlantis Components, Inc. - Atlantis M Abutment in Zirconia for 3i Certain Interface- K063734.
DEVICE DESCRIPTION
TDS Abutment for Friadent Xive are titanium and ceramic-titanium abutments designed to be used in conjunction with specific dental implants utilizing the TDS Abutment screw, which is made of Ti-6A1-4V ELI titanium and is used to secure the abutment to the implant. In combination with
Confidential
MAR 3 1 2011
1
the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Abutment for Friadent Xive is compatible with the following implant systems which have an internal hex with flat-to-flat dimensions of 1.78mm or greater: Firadent: FRIALIT Implant, XiVA Implant; 3i: Internal Connect Type; Astra: Osseospeed Implant, Osseospeed TX Implant; BirHorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System, Laser-lok 3.0 implant system; Lifecore: Lifecore RENOVA™ Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System; Osstem: GS System; Nobel Biocare: Active Impalnt.
INTENDED USE OF THE DEVICE
ﺑ
TDS Abutment for Friadent Xive is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
This device is compatible with the following implant systems which have an internal hex with flat-to-flat dimensions of 1.78mm or greater: Firadent: FRIALJT Implant, XiVA Implant; 3i: Internal Connect Type: Astra: Osseospeed Implant, Osseospeed TX Implant; BioHorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System, Laser-lok 3.0 implant system: Lifecore: Lifecore RENOVA™ Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System; Osstem: GS System; Nobel Biocare: Active Implant.
TECHNOLOGICAL CHARACTERISTICS
TDS Abutment for Friadent Xive 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.
The basis for Pou Yu Biotechnology Co. Ltd.'s belief that TDS Abutment for Friadent Xive is substantially equivalent to the predicate devices is summarized in the following table.
2
510(k) Premarket Notification
:
| | Subject Device
Pou Yu Biotechnology Co.
TDS Abutment for Friadent Xive | FRIADENT GmbH.
XIVE TG Abutments
K032302 | Predicate Devices
Lifecore Biomedical Inc.
PrimaConnex® CAD/CAM
Abutment System
K072241 | Atlantis Components, Inc.
Atlantis™ Abutment in Zirconia for 3i
Certain Interface
K063734 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | TDS Abutment for Friadent Xive is
intended for use with dental implants
as a support for single or multiple
tooth prostheses in the maxilla or
mandible of a partially or fully
edentulous patient.
TDS Abutment for Friadent Xive is
compatible with the following implant
systems which have an internal hex
with flat-to-flat dimensions of
1.78mm or greater: Firadent:
FRIALIT Implant, XiVA Implant; 3i:
Internal Connect Type; Astra:
Osseospeed Implant, Osseospeed TX
Implant; BioHorizons: Internal
Implant System, Tapered Internal
Implant System, Single-Stage Implant
System, Laser-lok® 3.0 implant
system; Lifecore: Lifecore
RENOVAT™ Internal Hex Implant
System; Zimmer: Tapered
Screw-Vent Implant System,
Screw-Vent Implant System, AdVent
Implant System; Osstem: GS System;
Nobel Biocare: Active Impalnt. | The XIVE TG Abutment is
intended for use in the fabrication
of screw-retained and cementable
crowns and bridges. | The Lifecore PrimaConnex®
CAD/CAM Abutment System is
intended for use as an accessory to a
Lifecore PrimaConnex endosseous
implant to support a prosthetic
device in a partially or completely
edentulous patient. It is intended for
use to support single and multiple
tooth prostheses in the mandible or
maxilla. The prosthesis can be
cement retained to the abutment.
The abutment screw is intended to
secure the abutment to the
endosseous implant. The copings are
intended for use as a core structure
for a prosthetic restoration in
partially or fully edentulous
mandibles or maxillae in the
construction of single-unit cement
retained restorations on Lifecore
PrimaConnex CAD/CAM
Abutments. | The devices covered by this submission are
abutments which are placed into a dental
implant to provide support for a prosthetic
reconstruction. The Atlantis Abutment is
intended for use as an accessory to an
endosseous implant to support a prosthetic
device in a partially or completely edentulous
patient. It is intended for use to support
single and multiple tooth prosthesis, in the
mandible or maxilla. The prosthesis can be
cement retained to the abutment. The
abutment screw is intended to secure the
abutment to the endosseous implant. Please
note: Highly angled abutments (i.e. 30
degrees) on implants with diameters less than
4 mm are intended for the anterior region of
the mouth and are not intended for the
posterior region due to the limited strength of
the implant fixture. |
| Custom Design | | | | |
| Attachment | Implant level | Implant level | Implant level | Implant level |
| Restoration | Cement-retained | Cement-retained | Cement-retained | Cement-retained |
| CAD/CAM
processing | Yes | Yes | Yes | Yes |
| Material | | | | |
| Abutment | Ti-6Al-4V ELI;
Y-TZP Zirconia | Ti-6Al-4V ELI | Y-TZP Zirconia | Y-TZP Zirconia |
| Screw | Provided by Pou Yu Biotechnology
Co. Ltd. | Provided by individual
manufacturers for specified
implants | Provided by individual
manufacturers for specified implants | Provided by Atlantis Components, Inc. |
3
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 TDS Abutment for Friadent Xive 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 appropriate fit.
These testing results show that TDS Abutment for Friadent Xive 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.
CONCLUSION
Pou Yu Biotechnology Co. Ltd demonstrated that, for the purposes of FDA's regulation of medical devices, TDS Abutment for Friadent Xive is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Daniel Tsao Pou Yu Biotechnology Company, Limited No. 6, Fugong Road Fusing Township, Changhua City China Taiwan 506
MAR 3 1 2011
Re: K103339
Trade/Device Name: TDS Abutment for Friadent Xive Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment · Regulatory Class: II Product Code: NHA Dated: March 17, 2011 Received: March 17, 2011
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.
5
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
hh 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
6
510(k) Premarket Notification
Indications for Use
103339 510(k) Number (if known):
Device Name: TDS Abutment for Friadent Xive
Indications for Use:
TDS Abutment for Friadent Xive is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
This device is compatible with the following implant systems which have an internal hex with flat-to-flat dimensions of 1.78mm or greater: Firadent: FRIALIT Implant, XiVA Implant; 3i: Internal Connect Type; Astra: Osseospeed Implant, Osseospeed TX Implant; BioHorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System, Laser-lok® 3.0 implant system; Lifecore: Lifecore RENOVA™ Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System; Osstem: GS System; Nobel Biocare: Active 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, Qffice of Device Evaluation (ODE)
Susan Kurpe
(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices
Page 1 of 1
510(k) Number: K103339