(246 days)
Not Found
No
The description focuses on CAD/CAM fabrication based on clinician-defined parameters and mechanical testing, with no mention of AI or ML.
Yes
The device, NDX Custom Abutments, is intended for use with dental implants as a support for single or multiple tooth prostheses, which directly contributes to the restoration of normal function or structure in a patient, thereby meeting the definition of a therapeutic device.
No
The device is described as an abutment, which is a component used to support dental prostheses after a dental implant has been placed. Its function is to provide physical support for the prosthesis, not to diagnose a medical condition or disease.
No
The device description explicitly states that the device is a physical abutment made from titanium alloy, fabricated through a CAD/CAM scanning and milling process. It is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that the NDX Custom Abutments are physical components intended to be implanted into the maxilla or mandible to support dental prostheses. This is a surgical implant or dental device, not a device used for testing biological samples.
The information provided about the device's fabrication process (CAD/CAM), materials (titanium alloy), and mechanical testing further reinforces that it is a physical medical device for structural support, not an IVD.
N/A
Intended Use / Indications for Use
NDX Custom Abutments are 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.
NDX Abutment for Nobel Biocare Bränemark is compatible with the following implant systems:
Nobel Biocare: Bränemark System® Mk III Groovy
Bränemark System® Mk III Shorty
Bränemark System® Zygoma
NobelSpeedy Groovy
NobelSpeedy Shorty
NDX Abutment for Nobel Biocare Replace is compatible with the following implant systems:
Nobel Biocare: Nobel Replace® Select Straight
Nobel Replace Select Straight One Stage
Replace Select Tapered
Replace Select Tapered One Stage
Nobel Replace Straight
Nobel Replace Tapered
Nobel Replace Straight Groovy
Nobel Replace Tapered Groovy for the 3.5 mm (NP)
4.3 mm (RP), 5.0 mm (WP) and 6.0 mm implants
NDX Abutment for Nobel Active is compatible with the following implant system:
Nobel Biocare: NobelActive Implant
NDX Abutment for 3i External Hex is compatible with the following implant systems:
3i: NanoTite External Hex Connection Implants
Full OSSEOTITE External Hex Connection Implants
OSSEOTITE External Hex Connection Implant
NDX Abutment for 3i Certain Internal is compatible with the following implant system:
3i: Certain Internal Connection
Product codes
NHA
Device Description
NDX Custom Abutments are fabricated for a specific prosthetic case and implant interface using a Computer Assisted Design /Computer Assisted Manufacturing (CAD/CAM) scanning and milling process. Milling of NDX Custom Abutments includes anti-rotation features compatible with specific implant systems. Each abutment is made from titanium alloy. It is created according to the specific design parameters designated by the clinician. All components and parameters of the system remain identical to those cleared for the TDS Abutment System predicates. Abutments are available in diameters of 3.5, 4.1, 4.3, 5.0, 5.1, and 6.0 mm, and can be fabricated straight or with an angle up to 30°.
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 was conducted on worst-case constructs of NDX titanium abutments according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants and results showed adequate strength for their intended use. Extensive compatibility testing was performed in support of NDX Abutments. Multiple parameters of the NDX abutments and corresponding implants with designated screws were evaluated to determine appropriate fit.
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: engineering analysis, dimensional analysis, static and dynamic compression-bending testing according to ISO 14801, and sterilization validation according to ISO 17665.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K103339, K091392, K091026, K081460
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
National Dentex Corporation
NDX Custom Abutments
December 13, 2012
DEC 1 4 2012
ADMINISTRATIVE INFORMATION
Manufacturer Name:
National Dentex Corporation 2 Vision Drive Natick, MA 01760 Telephone: +1 (508) 907-7800 Fax: +1 (508) 907-6050
Official Contact:
Dell Dine
Representative/Consultant:
Linda Schulz or Kevin Thomas PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 Email: lschulz@paxmed.com kthomas@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: NDX Custom Abutments Classification Name: Abutment, Implant, Dental, Endosseous Classification Regulations: Endosseous dental implant 21 CFR 872.3630, Class II Product Code: NHA Classification Panel: Dental Products Panel Reviewing Branch: Dental Devices Branch
1
INTENDED USE
NDX Custom Abutments are 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.
| NDX Abutment for Nobel Biocare Bränemark is compatible with the following implant systems: | |
|---|---|
| Nobel Biocare: | Bränemark System® Mk III Groovy |
| Bränemark System® Mk III Shorty | |
| Bränemark System® Zygoma | |
| NobelSpeedy Groovy | |
| NobelSpeedy Shorty | |
| NDX Abutment for Nobel Biocare Replace is compatible with the following implant systems: | |
| Nobel Biocare: | Nobel Replace® Select Straight |
| Nobel Replace Select Straight One Stage | |
| Replace Select Tapered | |
| Replace Select Tapered One Stage | |
| Nobel Replace Straight | |
| Nobel Replace Tapered | |
| Nobel Replace Straight Groovy | |
| Nobel Replace Tapered Groovy for the 3.5 mm (NP) | |
| 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm implants | |
| NDX Abutment for Nobel Active is compatible with the following implant system: | |
| Nobel Biocare: | NobelActive Implant |
| NDX Abutment for 3i External Hex is compatible with the following implant systems: | |
| 3i: | NanoTite External Hex Connection Implants |
| Full OSSEOTITE External Hex Connection Implants | |
| OSSEOTITE External Hex Connection Implant | |
| NDX Abutment for 3i Certain Internal is compatible with the following implant system: | |
| 3i: | Certain Internal Connection |
DEVICE DESCRIPTION
NDX Custom Abutments are fabricated for a specific prosthetic case and implant interface using a Computer Assisted Design /Computer Assisted Manufacturing (CAD/CAM) scanning and milling process. Milling of NDX Custom Abutments includes anti-rotation features compatible with specific implant systems. Each abutment is made from titanium alloy. It is created according to the specific design parameters designated by the clinician. All components and parameters of the system remain identical to those cleared for the TDS Abutment System predicates. Abutments are available in diameters of 3.5, 4.1, 4.3, 5.0, 5.1, and 6.0 mm, and can be fabricated straight or with an angle up to 30°.
2
EQUIVALENCE TO MARKETED DEVICE
National Dentex submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, NDX Custom Abutments is substantially equivalent in indications and design principles to the following predicate devices, all manufactured by Pou Yu Biotechnology Co., Ltd.:
TDS Abutment for Friadent Xive - K103339. TDS Titanium Abutment for Nobel Biocare Bränemark - K091392, TDS Abutment for Nobel Biocare Replace - K091026, and TDS Abutment - K081460
The purpose of this submission is to give National Dentex Corporation the ability to utilize the currently cleared TDS CAD/CAM Abutment System for dental implant abutment fabrication. All component designs and parameters of the system remain identical to those previously cleared for the TDS CAD/CAM Abutment System.
Mechanical testing was conducted on worst-case constructs of NDX titanium abutments according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants and results showed adequate strength for their intended use. Extensive compatibility testing was performed in support of NDX Abutments. Multiple parameters of the NDX abutments and corresponding implants with designated screws were evaluated to determine appropriate fit.
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: engineering analysis, dimensional analysis, static and dynamic compression-bending testing according to ISO 14801, and sterilization validation according to ISO 17665.
The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.
Overall, NDX Custom Abutments have the following similarities to the predicate devices:
- have the same intended use, .
- . use the same operating principle,
- . incorporate the same design,
- . incorporate the same materials, and
- . have similar packaging and are sterilized using the same materials and processes.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 14, 2012
National Dentex Corporation C/O Ms. Linda K. Schulz PaxMed International, Limited Liability Company 12264 El Camino Real, Suite 400 SAN DIEGO CA 92130
Re: K121117
Trade/Device Name: NDX Custom Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 3, 2012 Received: December 5, 2012
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. 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.
4
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 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 devicerelated 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
Sincerely yours,
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
2012.12.14 Susan Runner DDS, MA 14:09:38 -05'00' Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Premarket Notification
NDX Custom Abutments
Indications for Use
510(k) Number: K121117
NDX Custom Abutments Device Name:
Indications for Use:
multudions for ober tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
NDX Abutment for Nobel Biocare Branemark is compatible with the following implant systems: Nobel Biocare: Branemark System® Mk III Groovy
Bränemark System® Mk III Shorty
Bränemark System® Zygoma
NobelSpeedy Groovy
NobelSpeedy Shorty
NDX Abutment for Nobel Biocare Replace is compatible with the following implant systems:
Nobel Biocare: Nobel Replace® Select Straight
Nobel Replace Select Straight One Stage
Replace Select Tapered
Replace Select Tapered One Stage
Nobel Replace Straight
Nobel Replace Tapered
Nobel Replace Straight Groovy
Nobel Replace Tapered Groovy for the 3.5 mm (NP)
4.3 mm (RP), 5.0 mm (WP) and 6.0 mm implants
NDX Abutment for Nobel Active is compatible with the following implant system: Nobel Biocare: NobelActive Implant
NDX Abutment for 3i External Hex is compatible with the following implant systems:
NanoTite External Hex Connection Implants
Full OSSEOTITE External Hex Connection Implants
OSSEOTITE External Hex Connection Implant
NDX Abutment for 31 Certain Internal is compatible with the following implant system: Certain Internal Connection 3i:
X Prescription Use (Part 21 CFR 801 Subpart D)
3i:
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)
Page 1 of 1
2012.12.14 Susan Runner DDS, MA -14:08:29 -05'00'
(Division Sign-Off) (Division of Anestheslology, General Hospital Infection Control, Dental Devices
510(k) Number:
Page 6 of 19