(137 days)
No
The device description and performance studies focus on the mechanical properties and compatibility of the titanium abutments, with no mention of AI or ML technology.
No.
The device is a prosthetic component that supports prosthetic rehabilitation, not a device intended for treating or curing a disease or condition.
No
The device is a prosthetic component used in dental rehabilitation, not for diagnosing medical conditions.
No
The device description explicitly states that the device is made of titanium alloy and is a physical component (abutment and screw) placed into a dental implant. It also describes physical testing performed on the device.
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. This is a surgical/dental procedure, not a diagnostic test performed on samples from the human body.
- Device Description: The device is a physical component (an abutment) made of titanium alloy, designed to be placed in the mouth. It's a medical device used in a dental procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The testing described is mechanical testing of the device itself, not diagnostic testing.
Therefore, the Inclusive® Titanium Abutments are a medical device, specifically a dental implant abutment, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1mm and 4.8 mm) and WN (4.8 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 F136 Standard. They are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1 mm and 4.8 mm) and WN (4.8 mm) sizes.
Prismatik Dentalcraft. Inc. provides premanufactured titanium abutments of a stock type with no inherent angulation which require further modification to obtain the desired shape before being used. The modifications are intended to be performed by dental laboratories with laboratory hand tools, as delineated in the device's instructions for use.
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 proposed device's substantial equivalence compared to the predicate device. 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.
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.)
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name encircling a symbol of three stylized human profiles facing right. The profiles are stacked on top of each other, with the top profile being the most prominent and the bottom profile being the least prominent. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 16, 2015
PRISMATIK DENTALCRAFT, INC. Mr. Armin Zehtabchi Senior RA 2212 Dupont Drive, Suite P Irvine, California 92612
Re: K151798
Trade/Device Name: Inclusive® Titanium Abutments compatible with: Straumann synOcta Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 14, 2015 Received: October 16, 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 (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,
Tina Kiang
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
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Indications for Use
510(k) Number (if known) K151798
Device Name
Inclusive® Titanium Abutments compatible with: Straumann synOcta Implant System
Indications for Use (Describe)
The Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
They are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1mm and 4.8 mm) and WN (4.8 mm) sizes.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a rainbow color scheme. To the right of the triangle is the company name in blue text. The text is stacked, with "PRISMATIK" on top, "DENTALCRAFT" in the middle, and ", INC." on the bottom.
B.
006_510 (K)-K151798 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: | November 16, 2015 |
| DEVICE IDENTIFICATION | |
| Trade/Proprietary Name: | Inclusive® Titanium Abutments compatible |
| with: Straumann synOcta 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 side of the logo is a triangle with a color gradient. The colors in the triangle range from blue to pink to yellow. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a blue sans-serif font.
C. IDENTIFICATION OF PREDICATE DEVICE
Trade/Proprietary Name: Primary Predicate Device: Inclusive® Titanium Abutments compatible with: Straumann Tissue Level Implants, (K141211)
Reference Device 1: Inclusive Titanium Abutments for NobelActive, Straumann Bone Level, Branemark, (K142118)
Reference Device 2: ITI synOcta Meso Abutments, (K033243)
D. PROPOSED 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 F136 Standard. They are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1 mm and 4.8 mm) and WN (4.8 mm) sizes.
Prismatik Dentalcraft. Inc. provides premanufactured titanium abutments of a stock type with no inherent angulation which require further modification to obtain the desired shape before being used. The modifications are intended to be performed by dental laboratories with laboratory hand tools, as delineated in the device's instructions for use.
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.
They are compatible with Straumann Standard Plus Tissue Level Implants in RN (implant diameter: 4.1 mm and 4.8 mm) and WN (implant diameter: 4.8 mm) sizes.
F. DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The comparison table below outlines and provides the similarities and the substantial equivalency of the Primary Predicate Device, the Inclusive® Titanium Abutments for Straumann Tissue Level Implants, K141211 (cleared by FDA on 10/22/2014), the Reference Device 1, the Inclusive Titanium Abutments for NobelActive, Straumann Bone Level, Branemark, (K142118), the Reference Device 2, the ITI synOcta Meso Abutments, (K033243) and the proposed device, the Inclusive® Titanium Abutments compatible with: Straumann synOcta Implant
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Image /page/5/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left side of the logo is a triangle with a gradient of colors, including pink, red, yellow, green, blue, and purple. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a blue sans-serif font. The text is stacked, with "PRISMATIK" on the top line, "DENTALCRAFT, INC." on the bottom line.
System. The platform diameters and connection are the same for the Proposed Device and the Reference Device 2 (K033243). The connection for the Proposed Device and the Primary Predicate Device (K141211) is also the same.
Prismatik believes that the comparative data presented in the preceding paragraphs demonstrate that proposed device, Inclusive® Titanium Abutments compatible with: Straumann synOcta Implant System is substantially equivalent to currently marketed devices for the same indications for use, and supports our claim of substantial equivalence to predicate Class II devices under the classification of abutment, implant, dental, endosseous (21 CFR 872.3630) that have previously been found to be substantially equivalent. Any differences between the proposed device, the Inclusive® Titanium Abutments compatible with: Straumann synOcta Implant System, and the predicate device do not introduce any new issues of safety or effectiveness.
(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 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 and is blue.
| Attributes | Primary Predicate Device | Reference Device (1) | Reference Device (2) | Proposed Device | Similarities /
Differences |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| | Inclusive Titanium
Abutments compatible with:
Straumann Tissue Level
Implants (K141211) | Inclusive Titanium
Abutments
compatible with:
Straumann Bone
Level Implants (K142118) | ITI synOcta Meso Abutments
(K033243) | Inclusive® Titanium
Abutments compatible with:
Straumann Tissue Level
synOcta Implant System | |
| | (Prismatik Dentalcraft, Inc.) | (Prismatik Dentalcraft, Inc.) | Straumann USA | (Prismatik Dentalcraft, Inc.) | |
| Indications
for Use | Inclusive Titanium Abutments
are pre-manufactured
prosthetic components directly
connected to endosseous
dental implants and are
intended for use as an aid to
prosthetic rehabilitation.
Inclusive Titanium Abutments
are compatible with
Straumann Standard
Plus Tissue Level Implants in
RN (4.1 mm and 4.8 mm) and
WN (4.8
mm) sizes. | 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 | Abutments are intended to be
placed into dental implants to
provide support for prosthetic
reconstructions such as crowns or
bridges. The ITI synOcta Meso
abutments are indicated for
cemented restorations in esthetic
areas of the mouth. The abutment
can be used in single tooth
replacements and multiple tooth
restorations. | Inclusive Titanium Abutments
are pre-manufactured prosthetic
components directly connected
to endosseous dental implants
and are intended for use as an
aid to prosthetic rehabilitation.
They are compatible with
Straumann Standard Plus
Tissue Level Implants in RN
(implant diameter: 4.1 mm and
4.8 mm) and WN (implant
diameter: 4.8 mm) sizes. | Same as
primary
predicate |
| Attributes | Primary Predicate Device | Reference Device (1) | Reference Device (2) | Proposed Device | Similarities /
Differences |
| | Inclusive Titanium
Abutments compatible with:
Straumann Tissue Level
Implants (K141211) | Inclusive Titanium
Abutments
compatible with:
Straumann Bone
Level Implants (K142118) | ITI synOcta Meso Abutments
(K033243) | Inclusive® Titanium
Abutments compatible with:
Straumann Tissue Level
synOcta Implant System | |
| Dimensions | Cylindrical Diameter: 9.4mm
RN: diameter 4.8mm;
WN: diameter 6.5mm | Cylindrical Diameter:
9.4mm Connection Length:
2.735mm | synOcta RN 4.8 mm
synOcta WN 6.5 mm | Cylindrical Diameter: 9.4mm
RN: diameter 4.8mm;
WN: diameter 6.5mm | Same as
Primary
Predicate
Device and
Reference
Device # 2 |
| Connection | Octagonal | Slot | Octagonal | Octagonal | Same as
Primary
Predicate
Device and
Reference
Device # 2 |
| Sterility | Packaged Non-sterile | Packaged Non-sterile | Packaged Non-sterile | Packaged Non-sterile | Same |
| Material | Titanium Alloy, Grade 23 | Titanium Alloy, Grade 24 | Ti-6AL-7Nb | Titanium Alloy, Grade 23 | Same |
| Picture of
Abutment | Image: abutment | Image: abutment | Image: abutment | Image: abutment | - |
| Attributes | Primary Predicate Device | Reference Device (1) | Reference Device (2) | Proposed Device | Similarities /
Differences |
| | Inclusive Titanium
Abutments compatible with:
Straumann Tissue Level
Implants (K141211) | Inclusive Titanium
Abutments
compatible with:
Straumann Bone
Level Implants (K142118) | ITI synOcta Meso Abutments
(K033243) | Inclusive® Titanium
Abutments compatible with:
Straumann Tissue Level
synOcta Implant System | |
| Picture of
Screw | Image: Primary Predicate Device Screw | Image: Reference Device (1) Screw | Image: Reference Device (2) Screw | Image: Proposed Device Screw | - |
| Abutment
Angle | None | 0°-30° | - | 0°-30° | Same as the
Reference
Device 1 |
| Abutment
Seat | Sits on a taper | Sits on a taper | Sits on a taper | Sits on a taper | Same |
| Screw Seat | Sits on a taper | Sits on a taper | Sits on a taper | Sits on a taper | Same |
| Anatomical
Site | Oral Cavity | Oral Cavity | Oral Cavity | Oral Cavity | Same |
| Construction | Machined | Machined | Machined | Machined | Same |
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Image /page/7/Picture/0 description: The image contains 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.
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Image /page/8/Picture/0 description: The image contains 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.
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Image /page/9/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a color gradient, transitioning from blue to pink. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC.", written in a blue sans-serif font. The logo is clean and professional, suggesting a modern and innovative dental company.
SUMMARY OF NON-CLINICAL TESTING (PERFORMANCE DATA) G.
Non-clinical test data was used to evaluate the proposed device's substantial equivalence compared to the predicate device.
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.
H. CONCLUSION FROM THE NON-CLINICAL TESTING (PERFORMANCE DATA)
The proposed device, the Inclusive® Titanium Abutments compatible with: Straumann synOcta Implant System has the same performance specifications, fundamental scientific technology and intended use as that of the Prismatik's Primary Predicate device, the Inclusive® Titanium Abutments compatible with: Straumann Tissue Level Implants, K141211 (cleared by FDA on 10/22/2014), the Reference Device 1, the Inclusive Titanium Abutments for NobelActive, Straumann Bone Level, Branemark, K142118 (cleared by FDA on 11/25/2014) and the Reference Device 2, the ITI synOcta Meso Abutments, (K033243). These devices are substantially equivalent, and that any differences between the proposed device, the Inclusive® Titanium Abutments compatible with: Straumann synOcta Implant System and the cited primary predicate and reference devices do not introduce any new issues or concerns.