(113 days)
Not Found
No
The summary describes a physical dental abutment and its mechanical testing, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is described as a prosthetic component used in rehabilitation, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a prosthetic component (abutment) used in dental implant rehabilitation, designed to support a prosthetic restoration. Its purpose is mechanical support and connection, not to diagnose a medical condition or disease.
No
The device description clearly states that the device is made of titanium and is a physical component (abutment) placed into a dental implant. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "prosthetic rehabilitation" by connecting to dental implants to support a prosthetic restoration. This is a direct clinical application within the oral cavity.
- Device Description: The device is a physical component (abutment) made of titanium, designed to be placed within the patient's mouth.
- 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 treatment. IVDs are typically reagents, instruments, or systems used in a laboratory or point-of-care setting for testing biological samples.
The device described is a medical device used in a surgical and restorative dental procedure, not an in vitro diagnostic test.
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:
- Straumann: Bone Level NC and RC implant sizes
- Nobel Biocare: Branemark RP size implant
- Nobel Biocare NobelActive NP and RP internal connection implants
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 fastened into the implant with a screw. Abutments are made of titanium grade 23 (Ti-6AL-4V ELI) and meet ASTM F-136 Standard.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral Cavity
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 device's safety and effectiveness, and determine substantial equivalence with predicate devices.
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 Reliability Calculation, Fatigue Testing and Static Load Failure Testing of finished assembled implant/abutment systems.
In addition, sterilization validation information and a 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 established that the predicate device is as safe, as effective, and performs as well or better than the predicate device(s).
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.)
0
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
November 25,2014
Prismatik Dentalcraft, Incorporated Mr. Brandon Shepard Regulatory Affairs & Quality Assurance Specialist 2212 Dupont Drive, Suite P Irvine, CA 92612
Re: K142118
Trade/Device Name: Inclusive® Titanium Abutments compatible with: Straumann Bone Level, Nobel Biocare Branemark, and Nobel Biocare NobelActive Implants. Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 24, 2014 Received: October 28, 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.
1
Page 2 - Mr. Shepard
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 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 Acting 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. On the left is a triangular prism with a color gradient. To the right of the prism is the company name, "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line. The text is in a blue sans-serif font.
Indications for Use Statement 004
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K142118
Device Name
Inclusive® Titanium Abutments compatible with: Straumann Bone Level, Nobel Biocare Branemark, and Nobel Biocare Nobel Active Implants.
Indications for Use (Describe)
Inclusive® Tianium 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:
- Straumann: Bone Level NC and RC implant sizes
- Nobel Biocare: Branemark RP size implant
- Nobel Biocare NobelActive NP and RP internal connection implants
Type of Use (Select one or both, as applicable)
2 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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangular prism with different colors. To the right of the prism is the company name, "PRISMATIK DENTALCRAFT, INC.", in blue font.
| 005 | 5100 |
|---|---|
| ----- | ------ |
(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.
| PRISMATIK DENTALCRAFT, INC. |
|---|
| 2212 Dupont Dr., Suite P |
| Irvine, CA 92612 |
| (949) 225-1269 / (978) 313-0850 |
| Primary Contact: |
| Brandon Shepard, (949) 225-1243 |
| Secondary Contact: |
| Marilyn Pourazar, (949) 225-1269 |
| November 24, 2014 |
| Inclusive® Titanium Abutments |
| compatible with: Straumann Bone Level, Nobel |
| Biocare Branemark , and Nobel Biocare |
| NobelActive Implants. |
| Endosseous Dental Implant Abutment |
| 872.3630 |
| NHA |
| 2 |
| Dental |
CONFIDENTIAL
B.
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Image /page/4/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color, including blue, pink, and yellow. The company name is written in blue, with "PRISMATIK" on top and "DENTALCRAFT, INC." below.
C. IDENTIFICATION OF PREDICATE DEVICE
Trade/Proprietary Name:
- 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 fastened into the implant with a screw. Abutments are made of titanium grade 23 (Ti-6AL-4V ELI) and meet ASTM F-136 Standard.
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:
- Straumann: Bone Level NC and RC implant sizes -
- Nobel Biocare: Branemark RP size implant -
- Nobel Biocare NobelActive NP and RP internal connection implants -
F. NON-CLINICAL TESTING
Non-clinical test data was used to evaluate the device's safety and effectiveness, and determine substantial equivalence with predicate devices.
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 Reliability Calculation, Fatigue Testing and Static Load Failure Testing of finished assembled implant/abutment systems.
In addition, sterilization validation information and a 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 established that the predicate device is as safe, as effective, and performs as well or better than the predicate device(s).
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Image /page/5/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a gradient of colors, including pink, blue, green, and yellow. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in blue font. The text is stacked on two lines.
SUBSTANTIAL EQUIVALENCE G.
Inclusive® Titanium Abutments compatible with Straumann Bone Level, Nobel Biocare Branemark, and Nobel Biocare NobelActive Implants are substantially equivalent to the Inclusive Titanium Abutment Blanks (K083192) identified in Section C above. They are substantially equivalent in intended use, materials, design and performance.
(See Comparison Tables below).
CONFIDENTIAL
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Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
| Predicate Device | Proposed Device | ||
|---|---|---|---|
| Inclusive Titanium | |||
| Abutment Blanks | |||
| (K083192) | Inclusive Titanium Abutments | ||
| compatible with: Straumann Bone | |||
| Level Implants | Similarities and | ||
| Differences | |||
| Manufacturer | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | N/A |
| Dimensions of Abutment | Cylindrical Diameter: 9.4mm | ||
| Connection Length: 2.735mm | Cylindrical Diameter: 9.4mm | ||
| Connection Length: 2.735mm | Same | ||
| Abutment Screw | |||
| Manufacturer | OEM (Straumann) | Inclusive (Prismatik) | Equivalent screw from |
| different manufacturer | |||
| Dimensions of Abutment | |||
| Screw | Length 7.85mm; M1.6 Thread | Length 7.85mm; M1.6 Thread | Same |
| Indications for Use | The Inclusive Abutment 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 | |||
| implants and are intended for use as an | |||
| aid in prosthetic rehabilitation. | Same Intended Use. | ||
| Different wording in the | |||
| Indications for Use | |||
| Platform Compatibility | Straumann Bone Level | ||
| NC and RC | Straumann Bone Level | ||
| NC and RC | Same | ||
| Connection | Slot | Slot | Same |
| Design/Construction | Machined | Machined | Same |
| Anatomical Site | Oral Cavity | Oral Cavity | Same |
| Abutment Angle | 0°-20° | 0°-30° | Similar; increased |
| angulation range | |||
| Implant Seat | Taper | Taper | Same |
| Screw Seat | Taper | Taper | Same |
| Material | Titanium Alloy | Titanium Alloy | Same |
| Predicate Device | |||
| Inclusive Titanium Abutment Blanks | |||
| (K083192) | Proposed Device | ||
| Inclusive Titanium Abutments compatible | |||
| with: Nobel Biocare Branemark Implants | Similarities and | ||
| Differences | |||
| Manufacturer | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | N/A |
| Dimensions of | |||
| Abutment | Cylindrical Diameter: 9.4mm | ||
| Across Flats Length: 2.71mm | Cylindrical Diameter: 9.4mm | ||
| Across Flats Length: 2.71mm | Same | ||
| Abutment Screw | |||
| Manufacturer | OEM (Nobel Biocare) | Inclusive (Prismatik) | Equivalent screw from |
| different manufacturer | |||
| Dimensions of | |||
| Abutment Screw | Length 7.3mm; M2.0 Thread | Length 7.3mm; M2.0 Thread | Same |
| Indications for Use | The Inclusive Abutment 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 | |||
| implants and are intended for use as an aid in | |||
| prosthetic rehabilitation. | Same Intended Use. | ||
| Different Indications for | |||
| Use statement. | |||
| Platform Compatibility | Nobel Biocare Branemark RP | Nobel Biocare Branemark RP | Same |
| Connection | External Hex | External Hex | Same |
| Design/Construction | Machined | Machined | Same |
| Anatomical Site | Oral Cavity | Oral Cavity | Same |
| Abutment Angle | 0°-20° | 0°-30° | Similar; increased |
| angulation range | |||
| Implant Seat | Flat | Flat | Same |
| Screw Seat | Flat | Flat | Same |
| Material | Titanium Alloy | Titanium Alloy | Same Titanium material |
Comparison of Predicate and Proposed Devices: Straumann Bone Level Platform
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Image /page/7/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with different colors. To the right of the triangle is the company name in blue font.
Comparison of Predicate and Proposed Devices: Nobel Biocare Branemark Platform
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Image /page/8/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in a sans-serif font, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
Comparison of Predicate and Proposed Devices: Nobel Biocare NobelActive Platform
| Predicate Device | Proposed Device | ||
|---|---|---|---|
| Inclusive Titanium | |||
| Abutment Blanks | |||
| (K083192) | Inclusive Titanium Abutments | ||
| compatible with: Nobel Biocare | |||
| NobelActive Implants | Similarities and Differences | ||
| Manufacturer | Prismatik Dentalcraft, Inc. | Prismatik Dentalcraft, Inc. | N/A |
| Dimensions of | |||
| Abutment | Cylindrical Diameter: 9.4mm | ||
| Across Flats Length: 2.235mm | Cylindrical Diameter: 9.4mm | ||
| Across Flats Length: 2.235mm | Same | ||
| Abutment Screw | |||
| Manufacturer | OEM (Nobel Biocare) | Inclusive (Prismatik) | Equivalent screw from |
| different manufacturer | |||
| Dimensions of | |||
| Abutment Screw | Length 7.3mm; M1.6 Thread | Length 7.3mm; M1.6 Thread | Same |
| Indications for Use | The Inclusive Abutment 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 implants and are | |||
| intended for use as an aid in prosthetic | |||
| rehabilitation. | Same Intended Use. Different | ||
| Indications for Use statement. | |||
| Platform Compatibility | Nobel Biocare NobelActive NP, RP | Nobel Biocare NobelActive NP, RP | Same |
| Connection | Internal Hex | Internal Hex | Same |
| Design/Construction | Machined | Machined | Same |
| Anatomical Site | Oral Cavity | Oral Cavity | Same |
| Abutment Angle | 0°-20° | 0°-30° | Similar; increased angulation |
| range | |||
| Implant Seat | Taper | Taper | Same |
| Screw Seat | Taper | Taper | Same |
| Material | Titanium Alloy | Titanium Alloy | Same |