(127 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and angulation correction of dental abutments, with no mention of AI or ML.
No.
The device description and intended use clearly state that it is a prosthetic component for dental implants, not a device for treating or curing a medical condition.
No
Explanation: The device is described as a prosthetic component (multi-unit abutment) used to support and retain dental restorations, not to diagnose a condition or disease.
No
The device description clearly states the device is a physical component (abutment) made of titanium alloy and is provided sterile, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The provided information clearly describes a prosthetic component (dental abutment) that is implanted into the body to support dental restorations. It is a physical device used in a surgical and restorative procedure, not a test performed on a specimen outside the body.
The device's function is to provide structural support for dental prosthetics, which is a completely different purpose than an IVD.
N/A
Intended Use / Indications for Use
Inclusive Multi-Unit Abutments are prosthetic components directly connected to endosseous dental implants and intended to provide support and retention for multi-unit screw-retained restorations. The 30-degree multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Multi-Unit Abutments with Angulations 17° and 30° are available in multiple cuff heights to provide angulation correction for off-angle implant placement. The abutments are in the following sizes: 3.5mm Platform - Angled 17° - 2mmH and 3mmH, 3.5mm Platform - Angled 30° - 3mmH, 4.5mm Platform - Angled 17° - 2mmH, 3mmH, and 5mmH, 4.5mm Platform - Angled 30° - 3mmH and 5mmH.
The abutment is secured to the implant with an abutment retaining screw. The abutment and abutment retaining screw are fabricated from titanium alloy. The tapered abutments facilitate multi-unit, screw-retained restoration, and are available in titanium 6AI-4V and will provide an angulation up to 30°. The abutments are provided Sterile (Gamma) and are packaged in glass vials suspended by a carrier with a screw cap and is shrink wrapped. The glass vial is sealed inside a Chevron pouch that is compatible with radiation.
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 support the decision of safety and effectiveness. Non-clinical testing consisted of analysis of platforms to identify worst-case test samples and their performance in accordance with the FDA guidance Class II Special controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The testing indicated that the device is safe and effective for its intended use and performed as well or better than the predicate device.
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 PRISMATIK DENTALCRAFT, INC. The logo consists of a black triangle on the left and the company name on the right. The triangle is divided into smaller triangles, creating a prism-like effect. The company name is written in bold, sans-serif font.
B.
OCT 1 2 2012
510 (k) Summary
This 510 (K) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.
SUBMITTER INFORMATION A.
Prismatik Dentalcraft, Inc. Company Name: Company Name 2212 Dupont Dr., Suite P. Company Address: Irvine, CA 92612 Company Phone: 949-399-1940 949-553-0924 Company FAX: Armin Zehtabchi, (949) 225-1234 Contact Person: Kathleen Dragovich, (949) 399-1940 Date Summary Prepared: October 9, 2012 DEVICE IDENTIFICATION Trade/Proprietary Name: Multi-Unit Abutments with Angulations 17° and 30° for InclusiveTapered Implant System 21 CFR Reference: 21 CFR 872.3630 21 CFR Common Name: Endosseous Dental Implant Abutment Classification: Class II
Dental NHA Panel:
C. IDENTIFICATION OF PREDICATE DEVICE
Trade/Proprietary Name:
Zimmer Dental Angled Tapered Abutment (K111853)
D. DEVICE DESCRIPTION
The Multi-Unit Abutments with Angulations 17° and 30° are available in multiple cuff heights to provide angulation correction for off-angle implant placement. The abutments are in the following sizes: 3.5mm Platform - Angled 17° - 2mmH and 3mmH, 3.5mm Platform - Angled 30° - 3mmH, 4.5mm Platform - Angled 17° - 2mmH, 3mmH, and 5mmH, 4.5mm Platform - Angled 30° - 3mmH and 5mmH.
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Image /page/1/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a black triangle on the left and the company name on the right. The company name is in a bold, sans-serif font.
The abutment is secured to the implant with an abutment retaining screw. The abutment and abutment retaining screw are fabricated from titanium alloy. The tapered abutments facilitate multi-unit, screw-retained restoration, and are available in titanium 6AI-4V and will provide an angulation up to 30°.
The abutments are provided Sterile (Gamma) and are packaged in glass vials suspended by a carrier with a screw cap and is shrink wrapped. The glass vial is sealed inside a Chevron pouch that is compatible with radiation.
E. INDICATIONS FOR USE
Inclusive Multi-Unit Abutments are prosthetic components directly connected to endosseous dental implants and intended to provide support and retention for multi-unit screw-retained restorations. The 30-degree multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration.
F. SUBSTANTIAL EQUIVALENCE
The Multi-Unit Abutments with Angulations 17° and 30° for Tapered Implant System are substantially equivalent to the Zimmer Dental Angled Tapered Abutment (K111853). These abutments are substantially equivalent in intended use, indication for use, material, design and performance.
2
:
. . . . .
.
Image /page/2/Picture/1 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a black triangle on the left and the company name on the right. The triangle is a geometric shape with sharp angles and lines. The company name is written in a bold, sans-serif font.
.
.
Comparison of Predicate Devices
| Elements of
Comparison | Prismatik's
Multi-Unit Abutments with
Angulations 17° and 30° for
Tapered Implant System | Zimmer Dental Angled
Tapered Abutment
(K111853) |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Titanium | Titanium |
| Indications | Inclusive Multi-Unit Abutments
are prosthetic components
directly connected to endosseous
dental implants and intended to
provide support and retention for
multi-unit screw-retained
restorations. The 30-degree
multi-unit abutments must be
used within 45 degrees of
parallelism for a splinted
restoration. The 17-degree
multi-unit abutments must be
used within 32 degrees of
parallelism for a splinted
restoration. | The Angled Tapered
Abutment is used for a
terminal or intermediate
abutment for screw-retained
multiple-unit restorations.
The 30Angled
Tapered Abutment must be
used within 45 degree of
parallelism for a
splinted restoration. The
15S0Angled Tapered
Abutment must be used
within 30 degrees of
parallelism for a splinted
restoration. |
| Abutment Angels | Up to 30° | Up to 30° |
| Platforms | 3.5, 4.5mm | 3.5, 4.5mm |
| Method of
Attachment | Internal screw threaded through
internal hex into implant | Internal screw threaded
through internal hex into
implant |
.
.
.
:
.
.
and the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution of the contribution of the co
()
:
.
、
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Image /page/3/Picture/0 description: The image shows a logo for Prismatik Dentalcraft, Inc. The logo consists of a black triangle on the left side and the company name on the right side. The triangle is filled with a gradient of black, with the darkest part at the bottom and the lightest part at the top. The company name is written in a bold, sans-serif font.
NON-CLINICAL TESTING G.
Non-clinical test data was used to support the decision of safety and effectiveness.
Non-clinical testing consisted of analysis of platforms to identify worst-case test samples and their performance in accordance with the FDA guidance Class II Special controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The testing indicated that the device is safe and effective for its intended use and performed as well or better than the predicate device.
H. CONCLUSION
The information provided in the submission demonstrates that the Multi-Unit Abutments for Angulations 17° and 30° for Inclusive Tapered Implant System are substantially equivalent to the Zimmer Dental Angled Tapered Abutment (K111853).
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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 12 2012
Ms. Kathleen Dragovich Manager, Regulatory Affairs/Quality Assurance Prismatik Dentalcraft, Incorporated 2212 Dupont Drive, Suite P Irvine, California 92612
Re: K121688
Trade/Device Name: Multi-Unit Abutments with Angulations 17° and 30° for Tapered Implant System
Regulation Number: 21 CFR 872.3630
Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA
Dated: August 22, 2012
Received: August 27, 2012
Dear Ms. Dragovich:
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.
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Page 2 - Ms. Dragovich
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 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 http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
signature
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure .
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Image /page/6/Picture/1 description: The image shows the logo for PRISMATIK DENTALCRAFT, INC. The logo consists of a black triangle on the left and the company name on the right. The triangle is a solid black color and is positioned so that one of its points is facing upwards. The company name is written in a bold, sans-serif font.
004-Indications for Use Statement
510 (K) Number (if known): To be determined
Multi-Unit Abutments with Angulations 17° and 30° for Device Name: Tapered Implant System
Indications for Use: Inclusive Multi-Unit Abutments are prosthetic components directly connected to endosseous dental implants and intended to provide support and retention for multi-unit screw-retained restorations. The 30-degree multi-unit abutments must be used within 45 degrees of parallelism for a splinted restoration. The 17-degree multi-unit abutments must be used within 32 degrees of parallelism for a splinted restoration.
Prescription Use: Yes No 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 ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Suarez
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: