(166 days)
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 Standard Plus Tissue Level Implants in RN (4.1 mm and 4.8 mm) and WN (4.8 mm) sizes.
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. Abutments are to be provided straight and are not intended for any angulation correction.
The provided text describes the submission for a 510(k) premarket notification for Inclusive® Titanium Abutments, compatible with Straumann® Standard Plus Tissue Level Implants. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed study of the device's performance against specific acceptance criteria.
However, based on the non-clinical testing summary, we can infer the types of acceptance criteria and the nature of the study conducted.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
Since specific numerical acceptance criteria and performance metrics are not explicitly stated in this document (which is common for 510(k) summaries focusing on substantial equivalence), we'll infer them from the types of tests conducted and describe the reported outcome.
| Acceptance Criteria Category (Inferred) | Specific Test Type (Inferred from "Non-clinical testing") | Reported Device Performance |
|---|---|---|
| Mechanical Integrity / Durability | Reliability Calculation and Testing | Device demonstrated sufficient reliability |
| Fatigue Strength Testing | Device demonstrated sufficient fatigue strength, performing as well as predicate devices. | |
| Static Load Failure Testing | Device demonstrated sufficient static load failure resistance, performing as well as predicate devices. | |
| Material Compatibility | Material composition (Titanium Alloy (ASTM F136) for abutment and screw) | Same material as Predicate I, similar to Predicate II. Implied to meet required biocompatibility and strength standards. |
| Implant/Abutment Compatibility | Assessment of fit with specified Straumann implants | Demonstrated implant to abutment compatibility. |
| Sterilization Efficacy | Sterilization validation (per ANSI/AAMI ST79 and ISO 17665-1) | Sterilization method established and recommended in Information for Use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the document. The testing involved "finished assembled implant/abutment systems of the worst case scenario," but the number of samples is not provided.
- Data Provenance: Not specified, but likely conducted in a lab setting by or for Prismatik Dentalcraft, Inc. The document does not indicate country of origin or whether it was retrospective or prospective in a clinical sense, as it was non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable. This was non-clinical engineering and materials testing, not a study requiring human expert assessment for ground truth.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This was non-clinical testing against predefined engineering standards and measurements, not a human reader study requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC study was not done. This device is a dental implant abutment, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the non-clinical testing, the "ground truth" would be established engineering standards, material specifications (e.g., ASTM F136 for titanium alloy), and the performance characteristics of the legally marketed predicate devices. The device's performance was compared against these established benchmarks.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a physical device, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, all facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
OCtober 22, 2014
Prismatik Dentalcraft, Incorporated Mr. Armin Zehtabchi Senior Regulatory Affairs 2212 Dupont Drive, Suite P Irvine, CA 92612
Re: K141211
Trade/Device Name: Inclusive® Titanium Abutments, compatible with Straumann® Standard Plus Tissue Level Implants Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 19, 2014 Received: September 22, 2014
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.
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Page 2 - Mr. Zehtabchi
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
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
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Image /page/2/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangular prism on the left side. To the right of the prism is the company name, "PRISMATIK" in bold, followed by "DENTALCRAFT, INC." in a smaller font.
004 Indications for Use Statement
510(k) Number (if known): K141211
| Device Name: | Inclusive ® Titanium Abutments, compatible with Straumann ® Standard Plus Tissue Level Implants |
|---|---|
| -------------- | ----------------------------------------------------------------------------------------------------------------------- |
| 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 Standard Plus Tissue Level Implants in RN (4.1 mm and 4.8 mm) and WN (4.8 mm) sizes. |
|---|---|
| ---------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Type of Use
Prescription Use: Yes > 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 A SEPARATE PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
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Image /page/3/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangular prism on the left side. To the right of the prism is the company name, "PRISMATIK" in bold, followed by "DENTALCRAFT, INC." in a smaller font.
005 510(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.
B.
| Company Name: | Prismatik Dentalcraft, Inc. |
|---|---|
| Company Address: | 2212 Dupont Dr., Suite PIrvine, CA 92612 |
| Company Phone: | (949) 225-1269 |
| Company FAX: | 949-553-0924 |
| Primary Contact Person: | Armin Zehtabchi, (949) 225-1234Senior RA |
| Secondary Contact Person: | Marilyn Pourazar, (949) 225-1269Sr. Director, RA/QA |
| Date Summary Prepared: | October 21, 2014 |
| DEVICE IDENTIFICATION | |
| Trade/Proprietary Name: | Inclusive® Titanium Abutments, compatible withStraumann® Standard Plus Tissue Level Implants |
| Common Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 872.3630 |
| Product Code: | NHA |
| Device Class: | II |
| Review Panel: | Dental |
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Image /page/4/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangle on the left side, with the word "PRISMATIK" in bold, black letters on the right side. Below the word "PRISMATIK" is the phrase "DENTALCRAFT, INC." in a smaller, black font. The logo is simple and modern, and the use of color in the triangle makes it visually appealing.
C. IDENTIFICATION OF PREDICATE DEVICE
Trade/Proprietary Name: ITI synOcta Meso Abutments (K033243) 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 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. Abutments are to be provided straight and are not intended for any angulation correction.
| Inclusive Titanium Abutments, compatible withStraumann Standard Plus Tissue Level Implants | ||
|---|---|---|
| Platform Compatibility | Straumann synOcta | |
| Platform Diameter (mm) | RN 4.8 mm, WN 6.5 mm | |
| Dimension of Abutment | Blank Abutment: 13.30 mm long, 9.44 mm diameter | |
| Dimensions of Screw | 8 mm long, M2.0 thread | |
| Connection | Octagonal | |
| Material | Titanium Alloy (ASTM F136) | |
| Design / Construction | Machined | |
| Surface Treatment | None | |
| Abutment Angle | Straight, 0° | |
| Implant Seat | Sits on a Taper | |
| Screw Seat | Sits on a Taper |
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 Standard Plus Tissue Level Implants in RN (4.1 mm and 4.8 mm) and WN (4.8 mm) sizes.
F. DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Inclusive Titanium Abutments, compatible with Straumann Standard Plus Tissue Level Implants, are substantially equivalent to the ITI synOcta Meso Abutments (K033243) and the Inclusive Titanium Abutment Blanks (K083192). They are substantially equivalent in intended use, materials, design, technological characteristics, and performance.
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Image /page/5/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangular graphic on the left, resembling a prism. To the right of the graphic, the word "PRISMATIK" is written in bold, uppercase letters. Below "PRISMATIK", the words "DENTALCRAFT, INC." are written in a smaller font size.
COMPARISON OF DEVICES
| PROPOSED | PREDICATE (I) | PREDICATE (II) | ||
|---|---|---|---|---|
| Inclusive TitaniumAbutments,compatible withStraumann StandardPlus Tissue LevelImplants | Inclusive TitaniumAbutment Blanks | ITI synOcta MesoAbutments | Similarities/Differencesof Devices | |
| Manufacturer | Prismatik Dentalcraft | Prismatik Dentalcraft | Straumann USA | - |
| 510(k) Number | K141211 | K083192 | K033243 | - |
| Indicationsfor Use | Inclusive TitaniumAbutments arepremanufacturedprosthetic componentsdirectly connected toendosseous dentalimplants and areintended for use as anaid in prostheticrehabilitation.Inclusive TitaniumAbutments arecompatible withStraumann StandardPlus Tissue LevelImplants in RN (4.1mm and 4.8 mm) andWN (4.8 mm) sizes. | Inclusive TitaniumAbutment Blank isintended to be usedin conjunction withendosseous implantsin the maxillaryand/or mandibulararch to providesupport for crowns,bridges oroverdentureprostheses. Theprosthesis can becement retained tothe abutment. Theabutment screw isintended to securethe abutment to theendosseous implant. | Abutments areintended to be placedinto dental implants toprovide support forprostheticreconstructions such ascrowns or bridges. TheITI synOcta Measoabutments areindicated for cementedrestorations in estheticareas of the mouth. Theabutment can be usedin single toothreplacements andmultiple toothrestorations. | SameIntendedUse |
| PlatformCompatibility | Straumann synOcta | - | Straumann synOcta | Same |
| PlatformDiameter (mm) | RN 4.8 mmWN 6.5 mm | - | RN 4.8 mmWN 6.5 mm | Same |
| Dimensions ofAbutment Screw | 8 mm longM2.0 thread | - | 8 mm longM2.0 thread | Same |
| Connection | Octagonal | - | Octagonal | Same |
| Material(Abutment &Screw) | Titanium Alloy(ASTM F136) | Titanium Alloy(ASTM F136) | Abutment: UnalloyedTitanium (ASTM F67)Screw: Titanium Alloy | Same withPredicate I.Similar withPredicate II. |
| Design /Construction | Machined | Machined | Machined | Same |
| Abutment Angle | 0° | 0°-20° | - | Similar |
| Implant Seat | 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 | Same |
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Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangular prism on the left side. To the right of the prism is the company name, "PRISMATIK" in bold, followed by "DENTALCRAFT, INC." in a smaller font.
G. SUMMARY OF NON-CLINICAL TESTING/PERFORMANCE DATA
Non-clinical test data was used to evaluate the proposed device's safety and effectiveness, and determine substantial equivalence with predicate devices. 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.
In addition, sterilization validation information and 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 has established substantial equivalency of the proposed device with predicate devices.
CONCLUSION FROM THE NON-CLINICAL TESTING/ PERFORMANCE H. DATA
The results of the nonclinical testing performed, demonstrate that Inclusive Titanium Abutments compatible with Straumann Standard Plus Tissue Level Implants perform as well as the predicate devices. Therefore the proposed device is substantially equivalent with the predicate devices cleared for the same intended use.
§ 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.)