(174 days)
Not Found
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 is a prosthetic component for dental implants, aiding in prosthetic rehabilitation rather than treating a disease or condition.
No
The device is an abutment for dental implants, described as a "prosthetic component," and its purpose is to "provide support for a prosthetic restoration." It aids in "prosthetic rehabilitation," which indicates a treatment rather than a diagnostic function.
No
The device description clearly states the device is made of titanium alloy and is a physical component (abutment and screw) placed into a dental implant. This indicates it is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "premanufactured prosthetic component directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation." This describes a device used in vivo (within the body) for structural support, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a physical component placed into a dental implant to support a restoration. This is consistent with a medical device used for treatment or rehabilitation, not for diagnostic testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances or markers
- Providing information for diagnosis, monitoring, or screening
The information provided describes a dental prosthetic component, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Inclusive Titanium Abutments are compatible with Dentsply Implants Ankylos® C/X in 3.5, 4.5, 5.5, 7.0 mm sizes.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
Inclusive Titanium Abutments are endosseous implant abutments which are placed into the dental implant to provide support for a prosthetic restoration. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. Abutments and screws are made of titanium alloy (Ti-6AL-4V ELI) and meet ASTM F-136 Standard. Inclusive Titanium Abutments are compatible with Dentsply Implants Ankylos C/X in 3.5 mm, 4.5 mm, 5.5 mm, and 7.0 mm Ø sizes.
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)
Non-clinical test data was used to evaluate the proposed device's safety and effectiveness, and determine substantial equivalence with predicate devices. Clinical testing was not necessary to establish substantial equivalency of the device.
Non-clinical testing was performed in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and it consisted of testing finished assembled implant/abutment systems of the worst case scenario, through Reliability Calculation and Testing, as well as Fatigue Strength Testing and Static Load Failure Testing.
The testing performed demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices.
The results of the nonclinical testing performed, demonstrate that Inclusive Titanium Abutments, compatible with Dentsply Implants Ankylos C/X are as safe, as effective, and perform as well as the predicate devices. Therefore the proposed device is substantially equivalent with the predicate devices cleared for the same intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 stylized depiction of a human figure in profile, with three overlapping heads suggesting a sense of community or interconnectedness. The figure is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6,2015
Prismatik Dentalcraft, Incorporated Mr. Brandon Shepard Regulatory Affairs & Quality Assurance Specialist 2212 Dupont Drive, Suite P Irvine, CA 92612
Re: K141923 Trade/Device Name: Inclusive® Titanium Abutments, compatible with Dentsply Implants Ankylos® C/X Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 5, 2014 Received: December 8, 2014
Dear Mr. Shepard,
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. 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
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Page 2 - Mr. Shepard
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 (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Susan Runno DDS, MA
Erin Keith 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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Image /page/2/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangle on the left side, with the word "PRISMATIK" in bold, black letters to the right of the triangle. Below "PRISMATIK" is the text "DENTALCRAFT, INC." in a smaller, black font.
004 Indications for Use Statement
510(k) Number (if known): K141923
Device Name: Inclusive® Titanium Abutments, compatible with Dentsply Implants Ankylos® C/X
Indications for Use: Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Inclusive Titanium Abutments are compatible with Dentsply Implants Ankylos® C/X in 3.5, 4.5, 5.5, 7.0 mm sizes.
Type of Use
Prescription Use: Yes > No | (Part 21 CFR 801 Subpart D)
Over-the-Counter Use: Yes | | No (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
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Image /page/3/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo features a triangular prism on the left side, with each face of the prism displaying a different color. To the right of the prism is the company name, "PRISMATIK" in bold, followed by "DENTALCRAFT, INC." in a smaller font.
005 510(k) Summary
[As Required by 21 CFR 807.92]
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements 21 CFR 807.92.
SUBMITTER INFORMATION A.
B.
| Company Name: | PRISMATIK DENTALCRAFT, INC. |
|---|---|
| Company Address: | 2212 Dupont Dr., Suite P |
| Irvine, CA 92612 | |
| Company Phone / Fax: | (949) 225-1269 / (978) 313-0850 |
| Contact Person: | Primary Contact: |
| ● Brandon Shepard, RA/QA Specialist | |
| (949) 225-1243 | |
| Secondary Contact: | |
| ● Marilyn Pourazar, Sr. Director RA/QA | |
| (949) 225-1269 | |
| Date Summary Prepared: | December 5, 2014 |
DEVICE IDENTIFICATION
| Trade/Proprietary Name: | Inclusive ® Titanium Abutments,
compatible with Dentsply Implants Ankylos ® C/X |
|-------------------------|----------------------------------------------------------------------------------------------------------|
| Common Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 872.3630 |
| Product Code: | NHA |
| Device Class: | 2 |
| Review Panel: | Dental |
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C. IDENTIFICATION OF PREDICATE DEVICE
Trade/Proprietary Name: Atlantis Abutment for Dentsply Ankylos Implant (K101004) Inclusive Titanium Abutment Blanks (K083192)
D. DEVICE DESCRIPTION
Inclusive Titanium Abutments are endosseous implant abutments which are placed into the dental implant to provide support for a prosthetic restoration. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. Abutments and screws are made of titanium alloy (Ti-6AL-4V ELI) and meet ASTM F-136 Standard. Inclusive Titanium Abutments are compatible with Dentsply Implants Ankylos C/X in 3.5 mm, 4.5 mm, 5.5 mm, and 7.0 mm Ø sizes. Physical and technological characteristics of the proposed device are summarized in the comparison table below.
E. INDICATIONS FOR USE
Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Inclusive Titanium Abutments are compatible with Dentsply Implants Ankylos C/X in 3.5, 4.5, 5.5, 7.0 mm sizes.
F. SUBSTANTIAL EQUIVALENCE
Inclusive Titanium Abutments, compatible with Dentsply Implants Ankylos C/X, are substantially equivalent to the Atlantis Abutment for Dentsply Ankylos Implant (K101004) and the Inclusive Titanium Abutment Blanks (K083192). They are substantially equivalent in intended use, materials, as well as design, technological characteristics and performance.
NON-CLINICAL TESTING G.
Non-clinical test data was used to evaluate the proposed device's safety and effectiveness, and determine substantial equivalence with predicate devices. Clinical testing was not necessary to establish substantial equivalency of the device.
Non-clinical testing was performed in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and it consisted of testing finished assembled implant/abutment systems of the worst case scenario, through Reliability Calculation and Testing, as well as Fatigue Strength Testing and Static Load Failure Testing.
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Image /page/5/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangular shape on the left side, resembling a prism. To the right of the prism is the company name, "PRISMATIK" in bold, followed by "DENTALCRAFT, INC." in a smaller font size.
In addition, sterilization validation information and recommended sterilization method based on ANSI/AAMI ST79 and ISO 17665-1 is provided in the Information for Use.
The testing performed demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices.
CONCLUSION H.
The results of the nonclinical testing performed, demonstrate that Inclusive Titanium Abutments, compatible with Dentsply Implants Ankylos C/X are as safe, as effective, and perform as well as the predicate devices. Therefore the proposed device is substantially equivalent with the predicate devices cleared for the same intended use.
(See Comparison Table Below)
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Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangle on the left side, with the word "PRISMATIK" in bold, black letters to the right of the triangle. Below "PRISMATIK" is the text "DENTALCRAFT, INC." in a smaller, non-bold font.
| PREDICATES | PROPOSED | |||
|---|---|---|---|---|
| Atlantis Abutment for | ||||
| Dentsply Ankylos | ||||
| Implant | Inclusive Titanium | |||
| Abutment Blanks | Inclusive Titanium | |||
| Abutments, | ||||
| compatible with | ||||
| Dentsply Implants | ||||
| Ankylos C/X | Similarities / | |||
| Differences | ||||
| of Devices | ||||
| Manufacturer | Astra Tech | Prismatik | Prismatik | - |
| 510(k) No. | K101004 | K083192 | K141923 | - |
| Indications | ||||
| for Use | The Atlantis Abutment | |||
| is intended for use with | ||||
| 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 or screw retained | ||||
| to the abutment. The | ||||
| abutment screw is | ||||
| intended to secure the | ||||
| abutment to the | ||||
| endosseous implant. | The Inclusive | |||
| Titanium Abutment | ||||
| Blank is intended to be | ||||
| used in conjunction | ||||
| with endosseous | ||||
| implants in the | ||||
| maxillary and/or | ||||
| mandibular arch to | ||||
| provide support for | ||||
| crowns, bridges or | ||||
| overdenture | ||||
| prostheses. The | ||||
| prosthesis can be | ||||
| cement retained to the | ||||
| abutment. The | ||||
| abutment screw is | ||||
| intended to secure the | ||||
| abutment to the | ||||
| endosseous implant. | Inclusive Titanium | |||
| Abutments are | ||||
| premanufactured | ||||
| prosthetic | ||||
| components directly | ||||
| connected to | ||||
| endosseous dental | ||||
| implant and are | ||||
| intended for use as | ||||
| an aid in prosthetic | ||||
| rehabilitation. | Same | |||
| Intended | ||||
| Use | ||||
| Dimensions of | ||||
| Abutment | 11.5° Taper, | |||
| 2.84 Gage Point | Cylinder Ø 9.43mm | Cylinder Ø 9.43mm | ||
| 11.5° Taper, | ||||
| 2.84 Gage Point | Same | |||
| Abutment | ||||
| Screw | Integrated fastening | |||
| screw (mobile, not | ||||
| removable) | Detached and | |||
| removable | Detached and | |||
| removable | Same | |||
| Platform | ||||
| Compatibility | Ankylos C/X | |||
| 3.5mm, 4.5mm, | ||||
| 5.5mm, 7.0mm | Various (Straumann | |||
| Bone Level, | ||||
| NobelActive, | ||||
| Branemark) | Ankylos C/X | |||
| 3.5mm, 4.5mm, | ||||
| 5.5mm, 7.0mm | Same | |||
| Connection | Unigrip | Hexagon | Unigrip | Same |
| Material | Ti-6AL-4V ELI | |||
| (ASTM F-136) | Ti-6AL-4V ELI | |||
| (ASTM F-136) | Ti-6AL-4V ELI | |||
| (ASTM F-136) | Same | |||
| Design / | ||||
| Construction | Machined | Machined | Machined | Same |
| Abutment | ||||
| Angle | 0°-30° | 0°-20° | 0°-30° | Same |
| Implant Seat | Taper | Taper | Taper | Same |
| Screw Seat | Taper | Flat | Taper | Same |