(138 days)
No
The device description and performance studies focus on the mechanical properties and compatibility of titanium abutments, with no mention of AI or ML.
No
The device is described as a "premanufactured prosthetic component" used as an "aid to prosthetic rehabilitation," not a device intended for treating or curing a disease or condition.
No
The device description states that the product is a "premanufactured prosthetic component directly connected to endosseous dental implants and are intended for use as an aid to prosthetic rehabilitation." This indicates the device is a treatment component, not a diagnostic tool. There is no mention of it being used to detect, diagnose, treat, prevent, or mitigate disease.
No
The device description explicitly states the abutments are made of Titanium Alloy (Ti-6Al-4V) and are premanufactured prosthetic components, indicating a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "premanufactured prosthetic component directly connected to endosseous dental implants and are intended for use as an aid to prosthetic rehabilitation." This describes a device used in vivo (within the body) for structural support and restoration, not for testing samples in vitro (outside the body) to diagnose or monitor a condition.
- Device Description: The description details the material (Titanium Alloy), its function as a connection to dental implants, and its compatibility with a specific implant system. This aligns with a medical device used for surgical and prosthetic purposes, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect specific analytes, or provide diagnostic information.
Therefore, the Inclusive Titanium Abutments are a medical device used in dentistry for prosthetic rehabilitation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
Inclusive® Titanium Abutments for Hiossen HG Implant System are made of Titanium Alloy (Ti-6Al-4V) and are premanufactured prosthetic components connected directly to the endosseous dental implant and intended as an aid in prosthetic rehabilitation. They are compatible with Hiossen HG Implant System (Mini and Standard).
The anti-rotational feature for Inclusive® Titanium Abutment is a hexagon. The numerical value which defines the across flats of the hexagon is 2.10 mm for the Mini, and 2.50 mm for Standard. Both have a tolerance range of ±0.05 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral Cavity / Tissue Level
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 equivalence, 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, and the testing results and evaluations demonstrate the implant to abutment compatibility between the proposed and predicate/reference devices. The detailed discussion and the testing procedure can be found in Section 018 (Performance Testing-Bench).
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.
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 seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three human profiles facing right, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 7, 2015
PRISMATIK DENTALCRAFT, INC. Mr. Armin Zehtabchi Senior RA 2212 Dupont Dr., Suite P Irvine, California 92612
Re: K151375
Trade/Device Name: Inclusive Titanium Abutments compatible with: Hiossen HG Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 21, 2015 Received: May 22, 2015
Dear Mr. Zehtabchi:
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
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, 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
2
| Form Approved: OMB No. 0910-0120 | |
|---|---|
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. |
| 510(k) Number (if known) | TBD |
|---|---|
| Device Name | Inclusive® Titanium Abutments compatible with: Hiossen HG Implant System |
| Indications for Use (Describe) | Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation. |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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:
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"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."
3
Image /page/3/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with different colors. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC."
B.
006_510 (K) Summary-807.92(c)
This 510 (k) summary is being submitted in accordance with the requirements of SMDA of 1990 and 21 CFR 807.92.
SUBMITTER INFORMATION A.
| Company Name: | Prismatik Dentalcraft, Inc. |
|---|---|
| Company Address: | 2212 Dupont Dr., Suite P, |
| Irvine, CA 92612 | |
| Company Phone: | 949-225-1269 |
| Company FAX: | 949-553-0924 |
| Facility Registration Number: | 3005477956 |
| Primary Contact Person: | Armin Zehtabchi, (949) 225-1234 |
| Senior RA Specialist | |
| Secondary Contact Person | Marilyn Pourazar, (949) 225-1269 |
| Senior Director, RA/QA | |
| Date Summary Prepared: | September 25, 2015 |
| DEVICE IDENTIFICATION | |
| Trade/Proprietary Name: | Inclusive® Titanium Abutments compatible |
| with: Hiossen HG Implant System | |
| 21 CFR Reference: | 21 CFR 872.3630 |
| 21 CFR Common Name: | Abutment, implant, dental, endosseous |
| Classification: | Class II, NHA |
| Panel: | Dental |
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Image /page/4/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left is a triangular prism with a color gradient from blue to pink. To the right of the prism is the company name, "PRISMATIK DENTALCRAFT, INC." in a sans-serif font. The text is a dark teal color.
C. IDENTIFICATION OF PREDICATE DEVICE
Trade/Proprietary Name:
Predicate Device: Inclusive® Titanium Abutments for Astra Tech OsseoSpeed Implants=510(k)-K100993
Reference Device: HS/HG Prosthetic System-510(k)K100245
D. PROPOSED DEVICE DESCRIPTION
Inclusive® Titanium Abutments for Hiossen HG Implant System are made of Titanium Alloy (Ti-6Al-4V) and are premanufactured prosthetic components connected directly to the endosseous dental implant and intended as an aid in prosthetic rehabilitation. They are compatible with Hiossen HG Implant System (Mini and Standard).
The anti-rotational feature for Inclusive® Titanium Abutment is a hexagon. The numerical value which defines the across flats of the hexagon is 2.10 mm for the Mini, and 2.50 mm for Standard. Both have a tolerance range of ±0.05 mm.
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 to prosthetic rehabilitation.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE F.
Inclusive® Titanium Abutments compatible with: Hiossen HG Implant System is substantially equivalent to the Predicate Device, Inclusive® Titanium Abutments for Astra Tech OsseoSpeed Implants-510(k)-K100993, and the Reference Device, HS/HG Prosthetic System-510(k)-K100245 identified in Section C above. They are substantially equivalent in intended use, materials, design and performance.
(See Comparison Tables below)
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Image /page/5/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.
| Attribute | Reference Device (1) | Predicate Device (1) | Proposed Device | Similarities
and
Differences
of Devices |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| | HS/HG Prosthetic
System (K100245)
Osstem Implant
Co. Ltd
(Subsidiary of
Hiossen Inc) | Inclusive® Titanium Abutment
for Astra Tech OsseoSpeed™
Implants (K100993)
Prismatik Dentalcraft, Inc. | Inclusive Titanium
Abutments compatible
with: Hiossen HG Implant
System
Prismatik Dentalcraft, Inc. | |
| Dimensions of
Abutment | Mini - 2.1 Across
Flats of Hex
Standard - 2.5
Across Flats of
Hex | 3.5/4.0 - 2.1 Across Flats of Hex
4.5/5.0 - 2.5 Across Flats of Hex | Mini - 2.1 Across Flats of
Hex
Standard - 2.5 Across Flats of
Hex | Same |
| Dimensions of
Abutment Screw | Mini - Length -
10.7mm, Screw
Head - 2.2mm
Standard - Length -
8.85mm, Screw
Head - 2.5mm | 3.5/4.0 - Length 8.25mm, Screw
Head 2.33mm 4.5/5.0 - Length -
10.3mm, Screw Head 2.33mm | Mini - Length - 10.3mm,
Screw Head - 2.2mm
Standard - Length - 8.35mm,
Screw Head - 2.3mm | Different
screws
dimensions |
| Indications for
Use | HS/HG Prosthetic
System is intended
for use with the
dental implant to
provide support for
prosthetic
restorations such as
crowns, bridges, or
overdentures. | The Inclusive Titanium
Abutments for Astra
OsseoSpeed™ Implants are
premanufactured
prosthetic components directly
connected to endlosseous dental
implants and are intended
for use as an aid in prosthetic
rehabilitation. They are
compatible with the Astra Tech
OsseoSpeed™ 3.0, 3.5, 4.0, 4.5,
5.0 implants. | Inclusive Titanium
Abutments are
premanufactured prosthetic
components directly
connected to endosseous
dental implant and are
intended for use as an aid in
prosthetic rehabilitation. | Similar
intended use
for the
additional use
with Hiossen
mini
2.1 and
Standard 2.5 |
| Platform
Diameter
Compatibility | Hiossen HG Mini
(2.1 Across Flats
of Hex and
Standard (2.5
Across Flats of
Hex | Astra Tech OsseoSpeed™
Implants 3.5/4.0
4.5/5.0 | Hiossen HG
Mini - 2.1 Across Flats of
Hex
Standard - 2.5 Across Flats
of Hex | Same as
Reference
predicate |
| Connection | Hexagonal | Hexagonal | Hexagonal | Same |
| Material | Titanium alloy
(Ti-6AL-4V) | Titanium alloy
(Ti-6AL-4V) | Titanium alloy
(Ti-6AL-4V) | Same |
| Design /
Construction | Machined | Machined | Machined | Same |
| Attribute | Reference Device (1) | Predicate Device (1) | Proposed Device | Similarities
and
Differences
of Devices |
| | HS/HG Prosthetic
System
(K100245)
Osstem Implant
Co. Ltd
(Subsidiary of
Hiossen Inc) | Inclusive® Titanium Abutment
for Astra Tech OsseoSpeed™
Implants (K100993)
Prismatik Dentalcraft, Inc. | Inclusive Titanium
Abutments compatible
with: Hiossen HG Implant
System
Prismatik Dentalcraft, Inc. | |
| Anatomical Site /
Placement | Oral Cavity /
Tissue Level | Oral Cavity / Tissue Level | Oral Cavity / Tissue Level | Same |
| Abutment Angle | 0-30° | 0-20° | 0-30° | Similar |
Table 1 – Comparison between Predicate and Proposed Device
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Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangular prism with different colors radiating from the center. To the right of the prism is the company name, "PRISMATIK DENTALCRAFT, INC." in blue text.
G. NON-CLINICAL TESTING (PERFORMANCE DATA)
Non-clinical test data was used to evaluate the device's equivalence, 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, and the testing results and evaluations demonstrate the implant to abutment compatibility between the proposed and predicate/reference devices. The detailed discussion and the testing procedure can be found in Section 018 (Performance Testing-Bench). The applicable standards that are used in this submission are listed below:
| Applicable Standards | |
|---|---|
| ASTM F136-12a | Standard for Wrought Titanium-6Aluminum- |
| 4Vanadium ELI (Extra Low Interstitial) Alloy | |
| for Surgical Implant Applications | |
| AAMI/ANSI/ISO 10993-1:2009 | Biological Evaluation of Medical Devices - Part |
| 1: Evaluation and Testing within a Risk | |
| Management Process (Biocompatibility) | |
| ISO14801:2007 | Dentistry - Implants - Dynamic fatigue test for |
| endosseous dental implants | |
| AAMI/ANSI 17665:-1:2006 | Sterilization of health care products - Moist Heat |
- Part 1: Requirements for the development,
validation and routine control of a sterilization
process for medical devices |
| AAMI/ANSI/ISO 17665-2:2009 | Sterilization of Health Care Products - Radiation - Part 2: Guidance of on the application of ISO
17665-1 |
| ANSI/AAMI ST79:2010 &A1:2010 &
A2:2011 & A3:2012 & A4:2013 | (Consolidated Text) Comprehensive guide to
steam sterilization and sterility assurance in
health care facilities |
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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 a gradient of colors, including blue, pink, and yellow. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a blue sans-serif font.
Inclusive® Titanium Abutments are manufactured from biocompatible titanium grade 23 (Ti-6AL-4V ELI) and it meets ASTM F-136 Standard. In accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", in lieu of performing biocompatibility testing per ISO 10993-1 for the subject device, we have identified several of Prismatik own predicate devices with identical materials, same manufacturing process, and same type/duration of patient contact:
- K073217, Inclusive® Abutment for Zimmer, 3i and Nobel Biocare Implants -
- K100993, Inclusive® Titanium Abutments for Astra OsseoSpeed Implants -
- K121391, Inclusive® Titanium Abutment for Camlog Screw-Line Implants -
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.
CONCLUSION FROM THE NON-CLINICAL TESTING (PERFORMANCE DATA) H.
The proposed device, the Inclusive® Titanium Abutments compatible with: Hiossen HG Implant System have the same performance specifications, fundamental scientific technology and intended use as that of the Predicate Device, Inclusive® Titanium Abutments for Astra Tech OsseoSpeed Implants-510(k)-K100993, and the Reference Device, HS/HG Prosthetic System-510(k)-K100245 identified in Section C above. The testing performed demonstrated implant to abutment compatibility and supports the substantial equivalence of the subject device to the identified predicate.