(375 days)
No
The device description and performance studies focus on the mechanical properties, biocompatibility, and sterilization of a physical dental abutment, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a prosthetic component (abutment) used to support a dental restoration, not to treat or cure a disease or condition. Its purpose is mechanical support and rehabilitation, not therapy.
No
The device, Digitek Titanium Abutments, is described as a premanufactured prosthetic component directly connected to dental implants to provide support for a prosthetic restoration. Its intended use is as an aid in prosthetic rehabilitation, not for diagnosing disease or conditions.
No
The device description clearly states that the device is a physical component made of titanium (Digitek Titanium Abutments) and is intended to be physically placed into a dental implant. It is a hardware device.
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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the Digitek Titanium Abutments are "premanufactured prosthetic components directly connected to endosseous dental implants" and are used to "provide support for a prosthetic restoration." They are physical components placed within the mouth.
- Intended Use: The intended use is for "prosthetic rehabilitation" in conjunction with dental implants. This is a mechanical and structural function, not a diagnostic one based on analyzing biological samples.
The information provided focuses on the material properties, mechanical testing (fatigue), biocompatibility (cytotoxicity), and sterilization of a physical implant component. None of these relate to the analysis of biological specimens for diagnostic purposes.
N/A
Intended Use / Indications for Use
Digitek Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the ASTRA TECH Implant System OsseoSpeed™ 3.5mm, 4.0mm, 4.5mm, 5.0mm implants.
Product codes
NHA
Device Description
Digitek Titanium Abutments are endosseous implant abutments which are placed into a corresponding dental implant to provide support for a prosthetic restoration. These abutments are made of titanium grade Ti-6AI-4V ELI (meets ASTM Standard F136). The abutment is mounted into the implant with a screw. These abutments are compatible with the ASTRA TECH Implant System OsseoSpeed™ implants.
Digitek Titanium Abutments are provided straight only and are not intended to be modified to provide an angle correction.
Digitek Titanium Abutments are manufactured in two models "3.5" and "4.0". And a hexagonal prism at the base of the Digitek Titanium Abutments acts as an anti-rotation feature.
Digitek titanium Abutments are supplied in a non-sterile state and should be sterilized prior to installation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Fatigue testing was performed according to ISO 14801:2007, Dentistry --Implants -- Dynamic fatigue test for endosseous dental implants. Testing was performed on Digitek Titanium Abutment with the implants that they are intended to fit.
Final finished sterilized Digitek Titanium Abutment has been tested for cytotoxicity according to ISO 10993-5.
Sterilization method has been validated according to ANSI/AAMI ST79.
Reverse engineering analysis was performed on OEM abutments to obtain data used in the design the Digitek Titanium Abutment.
The Digitek Titanium Abutment conforms to the FDA Guidance Document for Endosseous Dental Implants and Abutments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 31, 2015
Digitek Dental Solutions Limited Mr. Alwin Ngai Director Units B-C Flat D. 6/F, Dragon Ind. Bldg., 93 King Lam St., Cheung Sha Wan, Kowloon, Hong Kong
Re: K141970
Trade/Device Name: Digitek Titanium Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 19, 2015 Received: July 02, 2015
Dear Mr. Ngai,
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.
1
Page 2 - Mr. Alwin Ngai
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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) K141970
Device Name Digitek Titanium Abutment
Indications for Use (Describe)
Digitek Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the ASTRA TECH Implant System OsseoSpeed™ 3.5mm, 4.0mm, 4.5mm, 5.0mm implants
Type of Use (Select one or both, as applicable)
ال Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Section 5: 510(k) Summary
1. Submitter Information
| Company Name: | Digitek Dental Solutions Limited |
|---|---|
| Company Address: | Units B-C, Flat D, 6/F, Dragon Ind. Bldg., 93 |
| King Lam St., Cheung Sha Wan, Kowloon, | |
| Hong Kong | |
| Company Phone: | (852) 2742 3210 |
| Company Fax: | (852) 3590 8715 |
| Contact Person: | Alwin Ngai |
| Date Prepared: | July 29, 2015 |
2. Device Identification
| Device Model Name: | Digitek Titanium Abutment |
|---|---|
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 872.3630 |
| Product Code: | NHA |
| Class | II |
| Panel | Dental |
3. Predicated Devices
| Primary | Predicate | Inclusive® Titanium Abutment for - Astra OsseoSpeed™ | ||
|---|---|---|---|---|
| Device | Implants, K100993 |
Reference predicate GC AADVA TI ABUTMENTS – BO AC SV BH, K103234 Device
4. Device Description
Digitek Titanium Abutments are endosseous implant abutments which are placed into a corresponding dental implant to provide support for a prosthetic restoration. These abutments are made of titanium grade Ti-6AI-4V ELI (meets ASTM Standard F136). The abutment is mounted into the implant with a screw. These abutments are compatible with the ASTRA TECH Implant System OsseoSpeed™ implants.
Digitek Titanium Abutments are provided straight only and are not intended to be modified to provide an angle correction.
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Digitek Titanium Abutments are manufactured in two models "3.5" and "4.0". And a hexagonal prism at the base of the Digitek Titanium Abutments acts as an anti-rotation feature.
Digitek titanium Abutments are supplied in a non-sterile state and should be sterilized prior to installation.
5. Indication for Use
Digitek Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the ASTRA TECH Implant System OsseoSpeed" 3.5mm, 4.0mm, 4.5mm, 5.0mm implants.
6. Substantial Equivalence
The proposed Digitek Titanium Abutments are substantially equivalent to the Inclusive® Titanium Abutments for - Astra OsseoSpeed™ Implants, and the GC AADVA TI ABUTMENTS - BO AC SV BH. These abutments are substantially equivalent in indications for use, material of body and screw, design and sterility status.
| Elements of
Comparison | Subject Device | Primary Predicate
Device | Reference Predicate
Device |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Digitek Titanium
Abutments | Inclusive® Titanium
Abutments for - Astra
OsseoSpeed™
Implants | GC AADVA TI
ABUTMENTS - BO
AC SV BH |
| 510(k)
Number | Applying | K100993 | K103234 |
| Indications
for Use | Digitek Titanium
Abutments are
premanufactured
prosthetic
components directly
connected to
endosseous dental
implants and are
intended for use as an
aid in prosthetic
rehabilitation. They
are compatible with
the ASTRA TECH
Implant System | Inclusive® Titanium
Abutments for - Astra
OsseoSpeed™
Implants are
premanufactured
prosthetic components
directly connected to
endosseous dental
implants and are
intended for use as an
aid in prosthetic
rehabilitation. They are
compatible with the
Astra Tech | "GC AADVA TI
ABUTMENTS - BO
AC SV BH" are dental
implant abutments for
use with partially or
fully edentulous
patients to restore
chewing function by
attachment to a dental
implant fixture placed
in the maxilla or
mandible. Each
abutment is
accompanied by a |
5
| | OsseoSpeed™
3.5mm, 4.0mm,
4.5mm, 5.0mm
implants. | OsseoSpeed™ 3.0, 3.5,
4.0, 4.5, 5.0 implants. | screw in order to
engage corresponding
dental implant fixture. |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material of
Body and
Screw | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V |
| Design | Abutment (main body)
assembly with
abutment screw.
Abutment connection
to implant is an
internal hexagon | Implant/Abutment
assembly with
abutment screw.
Abutment connection to
implant is an internal
hexagon | Allows the prosthesis
to be retained to the
abutment; abutment
screw is intended to
secure the abutment
to the endosseous
dental implant |
| Abutment
Platform
Diameters
(mm) | 3.5, 4.0, 4.5, 5.0mm | 3.0, 3.5, 4.0, 4.5,
5.0mm | Max. 6.0mm
Min. 2.5mm |
| Sterility
Status | Supplied in non-sterile
state | Supplied in non-sterile
state | Supplied in non-sterile
state |
7. Performance Testing
Fatigue testing was performed according to ISO 14801:2007, Dentistry --Implants -- Dynamic fatigue test for endosseous dental implants. Testing was performed on Digitek Titanium Abutment with the implants that they are intended to fit.
Final finished sterilized Digitek Titanium Abutment has been tested for cytotoxicity according to ISO 10993-5.
Sterilization method has been validated according to ANSI/AAMI ST79.
Reverse engineering analysis was performed on OEM abutments to obtain data used in the design the Digitek Titanium Abutment.
The Digitek Titanium Abutment conforms to the FDA Guidance Document for Endosseous Dental Implants and Abutments.
8. Conclusion
There are no known technological differences between Digitek Titanium
6
Abutments and those of the predicate devices. Thus, Digitek Titanium Abutments is substantially equivalent to the predicate devices.