(188 days)
No
The summary describes a customized dental abutment and screw, focusing on materials, compatibility, and mechanical testing. There is no mention of AI or ML in the intended use, device description, or performance studies. Customization is described as being based on dentist specifications and limited by physical dimensions, not algorithmic processing.
No.
This device is an abutment and screw used to support a prosthetic device on an endosseous implant, which facilitates the restoration of dental function, but it does not directly treat a disease or condition itself.
No
The device is an abutment and screw designed to support a prosthetic dental restoration. Its purpose is structural support, not diagnosis.
No
The device description clearly states the device is made of Ti-6A1-4V Eli titanium alloy and describes physical characteristics and testing (static/fatigue testing, dimensional analysis), indicating it is a physical medical device, not software-only.
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 for supporting a prosthetic device in patients who are partially or completely edentulous, used with an endosseous implant. This is a surgical/restorative application, not a diagnostic one.
- Device Description: The description details the material (titanium alloy) and its function in securing a prosthetic to a dental implant. This aligns with a medical device used in a surgical procedure.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, tissue, etc.), detect diseases, or provide information for diagnosis.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) as a component of a dental restoration.
N/A
Intended Use / Indications for Use
The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. The CreoDent Solidex® Customized Abutment and Screw are compatible with the following: - Sweden & Martina Premium Implant System 3.3mm and 3.8mm.
Product codes
NHA
Device Description
The Solidex® Customized Abutment and Screw is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 standard and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutment and Screw are compatible with: - Sweden & Martina Premium Implant System 3.3mm and 3.8mm. The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, height, collar height and angulation.
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 Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment and Screw connection platform. Reverse engineering dimensional analysis was conducted using OEM implant bodies, OEM abutments and OEM abutment screws. Sterilization was conducted according to ISO 17665-1 was performed. These results demonstrated that the Solidex® Customized Abutment and Screw have sufficient mechanical strength for their intended clinical application and are compatible with the Sweden & Martina Premium Implant for which they are intended. Biocompatibility information is leveraged from our previous 510k (K150012).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
CreoDent Prosthetics, Ltd. Calvin Shim Managing Director 29 West 30th Street 11th Floor New York, New York 10001 July 18, 2017
Re: K170100
Trade/Device Name: CreoDent Solidex® Customized Abutment and Screw Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 14, 2017 Received: June 20, 2017
Dear Calvin Shim:
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,
Mary S. Runner -A
for Lori Wiggins, MPT, CLT Acting 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) K170100
Device Name: CreoDent Solidex® Customized Abutment and Screw
Indication for Use:
The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.
The CreoDent Solidex® Customized Abutment and Screw are compatible with the following:
- Sweden & Martina Premium Implant System 3.3mm and 3.8mm ●
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-the-Counter Use (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)
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510(k) Summary
CreoDent Prosthetics. Ltd. Solidex® Customized Abutment and Screw
Submitter Information
Company Name: Company Address:
Company Telephone: Company Fax: Contact Person:
Date Summary Prepared:
CreoDent Prosthetics, Ltd. 29 West 30th Street, 11th Floor New York, New York 10001 (212) 302-3860 (212) 302-3865 Calvin Shim (212) 302-3860 Oct 1, 2016
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name:
Common Name:
Product Code: Classification Panel: Reviewing Branch:
CreoDent Solidex® Customized Abutment and Screw Endosseous Dental Implant Abutment, 21 CFR 872.3630 NHA Dental Products Panel Dental Devices Branch
INDICATIONS FOR USE
The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.
The CreoDent Solidex® Customized Abutment and Screw are compatible with the following:
- . Sweden & Martina Premium Implant System 3.3mm and 3.8mm
4
DEVICE DESCRIPTION
The Solidex® Customized Abutment and Screw is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 standard and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutment and Screw are compatible with:
- . Sweden & Martina Premium Implant System 3.3mm and 3.8mm
The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, height, collar height and angulation.
EQUIVALENCE TO MARKETED DEVICE
The CreoDent Solidex® Customized Abutments are substantially equivalent in intended use, material, design and performance to:
- Creodent Solidex Customlized Abutments (K150012) Primary Predicate ●
- Sweden & Martina Premium Implant System (K142242)
Conclusion:
The Creodent Solidex® Customized Abutment and Screw are substantially equivalent to the identified predicate products noted in this 510K Summary.
| Technological
Characteristics | CreoDent Solidex® Customized
Abutment and Abutment Screw | PRIMARY Predicate Device for
claimed equivalence: Creodent
Solidex Customized Abutment
(K150012) |
|----------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Abutment and Screw are Ti-6Al-4V Eli
titanium alloy meets ASTM F-136
Standard. | Abutment is Ti-6A1-4V Eli titanium
alloy meets ASTM F-136 Standard. It is
a higher grade material with more
tensile strength. The Screw is CP TI Gr4
meets ASTM F67 Standard. |
| Performance
Characteristics | Allows the prosthesis to be cemented or
screw retained to the abutment. The | Allows the prosthesis to be cemented
or screw retained to the abutment. The |
Table #1 Legally marketed predicate device (Abutment) to which equivalence is claimed:
5
| | abutment screw is designed to secure the
abutment to the endosseous implant. | abutment screw is designed to secure
the abutment to the endosseous
implant. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The CreoDent Solidex® Customized
Abutment and Screw is intended for use
with an endosseous implant to support a
prosthetic device in patients who are
partially or completely edentulous. The
device can be used for single or multiple-
unit restorations. The prosthesis can be
cemented or screw retained to the
abutment. An abutment screw is used to
secure the abutment to the endosseous
implant.
The CreoDent Solidex® Customized
Abutment and Screw are compatible with
the following:
Sweden & Martina Premium Implant
System 3.3mm and 3.8mm | The CreoDent Solidex® Customized
Abutment is intended for use with an
endosseous implant to support a
prosthetic device in patients who are
partially or completely edentulous. The
device can be used for single or multiple-
unit restorations. The prosthesis can be
cemented or screw retained to the
abutment. An abutment screw is used to
secure the abutment to the endosseous
implant.
The CreoDent Solidex® Customized
Abutment is compatible with the following:
Biomet 3i Osseotite Certain
Dental Implants 3.25mm, 4mm,
5mm, 6mm Straumann Bone Level implants
3.3mm, 4.1mm, 4.8mm |
| Dimensions
and
Angulations | Creodent Solidex Customized Abutment and
Screw sizes for
Sweden & Martina Premium Implant
System 3.3mm and 3.8mm Angles not to exceed up to 20 degrees from
the implant axis. | Creodent Solidex Customized Abutment
sizes for Biomet 3i Osseotite Certain
3.25mm, 4.0mm, 5.0mm and 6.0mm
diameter implants.
Straumann Bone Level implants 3.3mm,
4.1mm, 4.8mm
Angles not to exceed up to 20 degrees
from the implant axis. |
Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment and Screw connection platform. Reverse engineering dimensional analysis was conducted using OEM implant bodies, OEM abutments and OEM abutment screws. Sterilization was conducted according to ISO 17665-1 was performed. These results demonstrated that the Solidex® Customized Abutment and Screw have sufficient mechanical strength for their intended clinical application and are compatible with the Sweden & Martina Premium Implant for which they are intended. Biocompatibility information is leveraged from our previous 510k (K150012).
Substantial Equivalence discussion differences between the subject device and the Primary predicate is the compatible implant bodies. This comparison is for implant compatibility.
Table #2 Legally marketed predicate device (Abutment) to which equivalence is claimed:
| Technological
Characteristics | CreoDent Solidex® Customized
Abutment and Abutment Screw | Reference Predicate Device for
claimed equivalence: Sweden &
Martina Premium Abutments
(K142242) |
| ---------------------------------- | ------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------- |
|---|
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| Material | Abutment and Screw are Ti-6A1-4V Eli
titanium alloy meets ASTM F-136
Standard. | -Abutment and Screw: Same Titanium
Alloy |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance
Characteristics | Allows the prosthesis to be cemented or
screw retained to the abutment. The
abutment screw is designed to secure the
abutment to the endosseous implant. | The prosthetics can be cemented,
screw retained or friction fit to the
abutment. |
| Indications for
Use | The CreoDent Solidex® Customized
Abutment and Screw is intended for use
with an endosseous implant to support a
prosthetic device in patients who are
partially or completely endentulous. The
device can be used for single or multiple-
unit restorations. The prosthesis can be
cemented or screw retained to the
abutment. An abutment screw is used to
secure the abutment to the endosseous
implant.
The CreoDent Solidex® Customized
Abutment and Screw are compatible with
the following:
Sweden & Martina Premium Implant
System 3.3mm and 3.8mm | The Premium abutments is intended
for us with an endossous implant to
support a prosthetic device in partially
or completely edentulous patient. It is
intended for use to support single and
multiple tooth prosthetic device in the
mandible or maxilla. The prosthetics
can be cemented, screw retained or
friction fit to the abutment. |
| Dimensions
and
Angulations | Creodent Solidex Customized Abutment and
Screw sizes for
Sweden & Martina Premium Implant
System 3.3mm and 3.8mm
Angles not to exceed up to 20 degrees from
the implant axis. | Sweden & Martina Premium
Implant System 3.3mm and 3.8mm
Stock abutments |
Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment and Screw connection platform. Reverse engineering dimensional analysis was conducted using OEM implant bodies, OEM abutments and OEM abutment screws. Sterilization was conducted according to ISO 17665-1 was performed. These results demonstrated that the Solidex® Customized Abutment and Screw have sufficient mechanical strength for their intended clinical application and are compatible with the Sweden & Martina Premium Implant for which they are intended. Biocompatibility information is leveraged from our previous 510k (K150012).
Substantial Equivalence discussion differences: The only difference between the subject device and the reference predicate is that one is a stock abutment and Solidex is a Customized abutment. This difference is mitigated by fatigue testing, reverse engineering dimensional analysis.
The CreoDent Solidex® Customized Abutment is compatible with the following:
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| Compatible Device | Implant Diameters | Implant Lengths |
|---|---|---|
| Sweden & Martina Premium | ||
| Implant | 3.3mm | 10mm |
| 11.5mm | ||
| 13mm | ||
| 15mm | ||
| 3.8mm | 6mm | |
| 7mm | ||
| 8.5mm | ||
| 8.5mm | ||
| 10mm | ||
| 11.5mm | ||
| 13mm | ||
| 15mm |
CONCLUSION:
Solidex Customized Abutments incorporates the same material, similar indications for use, dimension, design, abutment seat, screw seat, anatomical site, connection and technological characteristics as the predicate device (K150012). Both the subject and predicate device share intended use. The only significant difference between the devices is the implant platform compatibility which has been mitigated through dynamic fatigue testing and 300 party compatibility testing. The Solidex Customized abutments are substantially equivalent to the predicate (K150012).