(182 days)
Not Found
Not Found
No
The summary describes a physical dental abutment and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as a support for dental prostheses rather than a device intended to treat or cure a disease or condition. Its function is structural and restorative.
No
Explanation: The device description states that the TDS Abutment is a support for single or multiple tooth prostheses, which is a restorative function, not a diagnostic one. There is no mention of it identifying, detecting, or assessing medical conditions.
No
The device description explicitly states that the device is a custom titanium or ceramic abutment, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the TDS Abutment is a physical component (titanium or ceramic) used in conjunction with dental implants to support prostheses within the mouth (maxilla or mandible). It is a structural device, not a test performed on a biological sample.
- Intended Use: The intended use is to support dental prostheses in the mouth of a patient. This is a direct clinical application within the body, not an in vitro test.
The information provided describes a medical device used for dental restoration, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
TDS Abutment 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 paient.
Product codes
NHA
Device Description
TDS Abutments are custom titanium or ceramic abutments designed to be used in conjunction with specific dental implants utilizing the screw provided by the implant manufacturer. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Abutments made of titanium are available for Nobel Biocare Replace® RP (Ø 4.3 mm) implants. TDS Abutments made of ceramic are available for Nobel Biocare Replace® WP (Ø 5.0 mm) implants and BioHorizons Internal 4.0 (Ø 4.5 mm platform) implants.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Ko 81460
TDS Abutment
510(k) Summary
NOV 21 2008
Pou Yu Biotechnology Co., Ltd TDS Abutment
ADMINISTRATIVE INFORMATION
Manufacturer Name: Pou Yu Biotechnology Co., Ltd. No. 6 Fugong Rd. Fusing Township Changhua County 506, Taiwan Telephone: +886-(0)4 768 5660 x5122 Fax: +886-(0)4 768 9032
Official Contact:
Daniel Tsao
Representative/Consultant:
Linda K. Schulz Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 email: 1schulz@paxmed.com flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name: Classification Regulations:
Product Code: Classification Panel: Reviewing Branch:
TDS Abutment Dental implant abutment Endosseous dental implant abutment Class II, 21 CFR 872.3630 NHA Dental Products Panel Dental Devices Branch
INTENDED USE
TDS Abutment 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 paient.
1
DEVICE DESCRIPTION
TDS Abutments are custom titanium or ceramic abutments designed to be used in conjunction with specific dental implants utilizing the screw provided by the implant manufacturer. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Abutments made of titanium are available for Nobel Biocare Replace® RP (Ø 4.3 mm) implants. TDS Abutments made of ceramic are available for Nobel Biocare Replace® WP (Ø 5.0 mm) implants and BioHorizons Internal 4.0 (Ø 4.5 mm platform) implants.
EQUIVALENCE TO MARKETED DEVICE
Pou Yu Biotechnology Co. Ltd demonstrated that, for the purposes of FDA's regulation of medical devices, TDS Abutment is substantially equivalent in indications and design principles to predicate devices, cach of which has been determined by FDA to be substantially equivalent to preamendment devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pou Yu Biotechnology Company, Limited C/o Ms. Linda K. Schulz Regulatory Affairs PaxMed International, LLC 11234 EL Camino Real, Suite 200 San Diego, California 92130
NOV 21 2008
Rc: K081460
Trade/Device Name: TDS Abutment Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NI-IA Dated: November 19, 2008 Received: November 20, 2008
Dear Ms. Schulz:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Schulz
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal sugencies. 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); good manufacturing practice requirements as sct 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runne
L. Chi S. Lin, Ph.D.
Chiu S. Lin, Ph. D Division 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): _ KO81400
Device Name: TDS Abutment
Indications for Use:
TDS Abutment 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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