(211 days)
Not Found
Not Found
No
The summary describes a premanufactured prosthetic component and a digital design process for milling, with no mention of AI or ML technologies.
No
The device provides support for prosthetic restorations and does not actively treat or alleviate a disease, injury, or medical condition.
No
The device description indicates it is a prosthetic component for supporting dental restorations, not a tool for diagnosing medical conditions.
No
The device description explicitly states that the device is a "premanufactured prosthetic component," which is a physical hardware component, not software.
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.
- Device Description and Intended Use: The description clearly states that Inclusive® Abutments are "premanufactured prosthetic components connected to endosseous dental implants... to provide support for cement-retained prosthetic restorations." This describes a physical medical device used in vivo (within the body) for structural support, not a test performed in vitro (outside the body) on a sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the Inclusive® Abutment is a dental prosthetic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Inclusive® Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement-retained prosthetic restorations.
All digitally designed abutments for use with Inclusive® Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.
Product codes
NHA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
edentulous or partially edentulous 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
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Description of the test set, sample size, data source, and annotation protocol
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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
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 4, 2016
Prismatik Dentalcraft, Inc. c/o Linda Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K160979
Trade/Device Name: Inclusive® Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 6, 2016 Received: October 7, 2016
Dear Linda 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.
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
1
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 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,
Michael J. Ryan -S
for Tina Kiang, Ph.D.
Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Inclusive Abutments
Indications for Use (Describe)
Inclusive® Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement-retained prosthetic restorations.
| Compatible Implant System | Implant Diameter (mm) | Platform Diameter (mm) |
|---|---|---|
| Astra Tech OsseoSpeed™ | 3.0, 3.5, 4.0, 4.5, 5.0 | 3.0, 3.5, 4.0, 4.5, 5.0 |
| Biomet 3i Osseotite® Certain® | 3.25, 4.0, 5.0, 6.0 | 3.4, 4.1, 5.0, 6.0 |
| Camlog Screw-line | 3.3, 3.8, 4.3, 5.0, 6.0 | 3.3, 3.8, 4.3, 5.0, 6.0 |
| Dentsply Ankylos | 3.5, 4.5, 5.5, 7.0 | 3.5, 4.5, 5.5, 7.0 |
| Hahn Tapered Implant System | 3.0, 3.5, 4.3, 5.0, 7.0 | 3.0, 3.5, 4.3, 5.0, 7.0 |
| Hiossen HG Implant System mini, standard | 3.5, 4.0, 4.5, 5.0 | 3.7, 4.2, 4.6, 5.1 |
| Inclusive Tapered Implant System | 3.7, 4.7, 5.2 | 3.5, 4.5 |
| Nobel Biocare Brånemark RP | 3.75, 4.0 | 4.1 |
| Nobel Biocare NobelActive™ NP, RP | 3.5, 4.3, 5.0 | 3.5, 3.9 |
| Nobel Biocare NobelReplace™ NP, RP, WP, 6.0 | 3.5, 4.3, 5.0, 6.0 | 3.5, 4.3, 5.0, 6.0 |
| Straumann Bone Level NC, RC | 3.3, 4.1, 4.8 | 3.3, 4.1, 4.8 |
| Straumann synOcta RN, WN | 4.1, 4.8 | 4.8, 6.5 |
| Zimmer Screw-Vent® | 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 |
All digitally designed abutments for use with Inclusive® Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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