(215 days)
No
The summary describes a physical dental abutment and its mechanical testing, with no mention of software, algorithms, or AI/ML technologies.
No.
The device is a prosthetic component for dental implants, aiding in prosthetic rehabilitation rather than treating or preventing a disease or condition.
No
The device is a prosthetic component used in dental rehabilitation, providing support for restorations. It does not perform any diagnostic function.
No
The device description clearly states it is a physical component made of titanium (Ti-6AL-4V ELI) and is placed into a dental implant. It is a hardware device.
Based on the provided text, 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 in prosthetic rehabilitation." This describes a device used in vivo (within the body) for structural support, not a device used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description reinforces its use as an "endosseous implant abutment which is placed in to the dental implant to provide support for a prosthetic restoration." This is a physical component for dental reconstruction.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information
- Using reagents or assays
The device is a medical device, specifically a dental prosthetic component, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Inclusive® Titanium Abutments for Camlog Screw-Line Implants 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 the CAMLOG Screw-Line Implants in 3.3mm, 3.8mm, 4.3mm, 5.0mm, and 6.0mm diameters.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Inclusive® Titanium Abutments for Camlog Screw-Line Implants are endosseous implant abutments which are placed in to the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. These abutments are made of titanium grade Ti-6AL-4V ELI (meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw.
These abutments are compatible with the CAMLOG Screw-Line Implants as follows: 3.3mm, 3.8mm, 4.3mm, 5.0mm, and 6.0mm diameters.
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 substantial equivalency.
The parameters of the abutment features that interface with the implant systems were determined by reverse engineering. The functionality of the abutments as well as their conformance to design input was further determined by laboratory mechanical testing. The following FDA's Guidance Document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments was used for the purpose of Implant to Abutment Compatibility. Static and fatigue tests were performed by following the ISO 14801: 2007- Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. All testing conducted met the acceptance criteria and evaluated the worst case scenario. Performance testing data indicated the compatibility between implant/abutment. In addition, the sterilization validation/instructions by following the ANSI-AAMI ST79-2006: Comprehensive guide to steam sterilization and sterility assurance in health care facilities is provided in the Information for Use (IFU). Furthermore, the Prismatik's predicate device (K100993) is made of Titanium alloy.
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/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 written in a bold, sans-serif font.
B.
K121391
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: 2212 Dupont Dr., Suite IJK, Company Address: Irvine, CA 92612 (949) 225-1269 Company Phone: 949-553-0924 Company FAX: Armin Zehtabchi, (949) 225-1234 Primary Contact Person: Marilyn Pourazar, (949) 225-1269 Secondary Contact Person December 5, 2012 Date Summary Prepared: DEVICE IDENTIFICATION Inclusive Titanium Abutments for Camlog Trade/Proprietary Name: Screw-Line Implants 21 CFR 872.3630 21 CFR Reference: Endosseous Dental Implant Abutment 21 CFR Common Name: Class II Classification: NHA Product Code: Dental Panel:
IDENTIFICATION OF PREDICATE DEVICE C.
Trade/Proprietary Name:
CAMLOG Implant System Abutments (K073553)
DEVICE DESCRIPTION
The Inclusive® Titanium Abutments for Camlog Screw-Line Implants are endosseous implant abutments which are placed in to the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated
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KI 21391
Image /page/1/Picture/1 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangular prism with different colors. To the right of the prism is the company name, "PRISMATIK DENTALCRAFT, INC.", in blue text.
for cemented restorations. These abutments are made of titanium grade Ti-6AL-4V ELI (meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw.
These abutments are compatible with the CAMLOG Screw-Line Implants as follows: 3.3mm, 3.8mm, 4.3mm, 5.0mm, and 6.0mm diameters.
INDICATIONS FOR USE D.
The Inclusive® Titanium Abutments for Camlog Screw-Line Implants 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 the CAMLOG Screw-Line Implants in 3.3mm, 3.8mm, 4.3mm, 5.0mm, and 6.0mm diameters.
SUBSTANTIAL EQUIVALENCE
The Inclusive® Titanium Abutments for Camlog Screw-Line Implants are substantially equivalent to the CAMLOG Implant System Abutments (K073553). These abutments are substantially equivalent in intended use, indication for use, material, design and performance.
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. :
.
・ . :
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 side and the company name on the right side. The company name is written in a bold, sans-serif font. The logo is simple and modern.
. .
| Elements of | Prismatik's | CAMLOG Implant |
|---|---|---|
| Comparison | Inclusive Titanium Abutments | System Abutments |
| for Camlog Screw-Line | (K073553) | |
| Implants | ||
| Material | Ti -6AL-4V ELI | Ti -6AL-4V |
| Indications | The Inclusive® Titanium | |
| Abutments for Camlog | ||
| Screw-Line Implants 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 the | ||
| CAMLOG Screw-Line | ||
| Implants. | CAMLOG Implant | |
| System Abutments are | ||
| intended to be used to | ||
| fabricate crowns and | ||
| bridges in conjunction | ||
| with CAMLOG dental | ||
| implants to support | ||
| prostheses in the | ||
| maxillary and/or | ||
| mandibular arch. | ||
| Platform | ||
| Diameters | ||
| (mm) | 3.3mm, 3.8mm, 4.3mm, 5.0mm, | |
| 6.0mm. | 3.3mm, 3.8mm, 4.3mm, | |
| 5.0mm, 6.0mm. | ||
| Design | Implant/Abutment assembly with | |
| abutment screw. Abutment | ||
| prosthetic connection to implant | ||
| is 3 internal radial features. | Implant/Abutment | |
| assembly with abutment | ||
| screw. Abutment | ||
| prosthetic connection to | ||
| implant is 3 internal | ||
| radial features. | ||
| Performance | Fatigue testing in accordance | |
| with ISO 14971 - Dynamic | ||
| fatigue test for endosseous dental | ||
| implants conducted to validate | ||
| mechanical compatibility with | ||
| Camlog implants. | Substantially equivalent | |
| in indications and design | ||
| to predicated devices | ||
| determined to be | ||
| substantially equivalent | ||
| to pre-amendment | ||
| devices. |
Comparison of Predicate Devices
·
:
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Image /page/3/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 written in a bold, sans-serif font.
E. NON-CLINICAL TESTING
Non-clinical test data was used to support the substantial equivalency.
The parameters of the abutment features that interface with the implant systems were determined by reverse engineering. The functionality of the abutments as well as their conformance to design input was further determined by laboratory mechanical testing. The following FDA's Guidance Document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments was used for the purpose of Implant to Abutment Compatibility. Static and fatigue tests were performed by following the ISO 14801: 2007- Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. All testing conducted met the acceptance criteria and evaluated the worst case scenario. Performance testing data indicated the compatibility between implant/abutment. In addition, the sterilization validation/instructions by following the ANSI-AAMI ST79-2006: Comprehensive guide to steam sterilization and sterility assurance in health care facilities is provided in the Information for Use (IFU). Furthermore, the Prismatik's predicate device (K100993) is made of Titanium alloy.
F. CONCLUSION
The information provided in the submission demonstrates that the Inclusive® Titanium Abutments for Camlog Screw-Line Implants are substantially equivalent to the Camlog Implant System Abutments.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, overlaid with three overlapping ribbons. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 10, 2012
Mr. Armin Zehtabchi Senior Regulatory Affairs / Quality Assurance Coordinator Prismatik Dentalcraft, Incorporated 2212 Dupont Drive, Suite P IRVINE CA 92612
Re: K121391
Trade/Device Name: Inclusive Titanium Abutment for Camlog Screw-Line Implants Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 5, 2012 Received: December 6, 2012
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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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 vours.
Anthem Lo m
Anthony D. Watson, B.S., M.S., M.B.A. 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 STATEMENT
510(K) Number: K121391
Device Name:
Inclusive Titanium Abutment for Camlog Screw-Line Implants
Indications for Use:
The Inclusive Titanium Abutments for Camlog Screw-Line Implants are premanufactured The inclusive Thamum Abauments for Cannon and implants and are intended for use prosthence components ancelly of the are compatible with the Camlog Screw-Line Implants in 3.3mm, 3.8mm, 4.3mm, 5.0mm and 6.0mm diameters.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
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Over-the-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
2012.12.10 Susan Runner DDS, MA 12:18:21 -05'00'
(Division Sign-Off) . (Division Signoli)
Division of Anesthesiology, General Hospital Division of Antonioental Devices
510(k) Number: