(602 days)
Not Found
No
The summary describes a standard dental implant and its components, focusing on materials, dimensions, and mechanical testing. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is intended to restore the patient's chewing function and provide support for prosthetic devices like artificial teeth, which are therapeutic functions.
No
The description clearly states the device's purpose is to provide support for prosthetic devices (like artificial teeth) and restore chewing function, indicating a therapeutic or restorative function rather than a diagnostic one.
No
The device description explicitly states it is made of Titanium Alloy and consists of physical components like implants, cover screws, healing abutment screws, and abutments, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Syntec Dental Implant is a physical device surgically placed in the body (in the jaw bone) to support prosthetic devices. It does not analyze any biological samples taken from the body.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, chemical reactions, or diagnostic information derived from such analysis.
Therefore, based on the provided information, the Syntec Dental Implant is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Syntec Dental Implant is intended to be surgically placed in the bone of the upper or lower jaw arches. To provide support for prosthetic devices, such as to restore the patient's chewing function, and artificial teeth. It is intended for delayed loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The Syntec Dental Implant provides Titanium Alloy (commercially followed by ASTM F136) intended to be surgically placed in the bone of the upper or lower jaw arches. To provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of implant, cover screw, healing abutment screw and abutments. The Syntec Dental Implant is for one and two stage surgical procedures. Its materials, dimensions, and intended use are similar to devices currently marked worldwide. The range of implant in diameter is from 3.4mm to 4.8mm and in length from 8.0mm to 14.0mm. The range of abutment in diameter is from 4.5mm to 6.5mm, and in length from 5.5mm to 12.0mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw arches
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)
Bench Testing:
Biomechanical testing:
- Static strength: ISO 14801
- Fatigue testing: ISO 14801
Biocompatibility: - Certificate of Raw material: ISO-10993
Sterilization: - Sterilization Validation of Gamma Irradiation: ISO 11137
- Sterilization Validation of Moist Heat: ISO 17665-1, ISO 17665-2, ISO 11737-1
- Sterilization Process Validation: and ISO 11737-2
Surface analysis: - Morphology: SEM
- Coating thickness: EN ISO 4288
- Ca/P ratio: EN ISO 11885-E22
- Residue analysis: ASTM F1854/ DIN EN ISO 4288
- Cytotoxicity: DIN EN ISO 10993-5
- Solubility: FDA guidance (2/21/97)
- Analysis of raw material: ASTM F1185 and ASTM F1609
- Adhesive Tensile Strength: ASTM F-1147
- Shear Strength: ASTM F-1044
Discussion of Biomechanical Studies: The experiments were according ISO 14801 (Dentistry - Implant - Dynamic Fatigue Test for Endosseous Dental Implants). In these experiments, the static strength and fatigue life were evaluated.
Key Results: The result of Dental Implant is substantially equivalent to 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.
Not Found
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
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
DEC 2 0 2012
510(k) SUMMARY
The summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
| Submitter's name : | Syntec Scientific Corporation |
|---|---|
| Address : | 2, Kung San Rd, |
| Chuan Shing Industrial Zone, | |
| Shen Kang, Chang Hua, | |
| Taiwan | |
| Tel : | 886-4-7987099 |
| Fax: | 886-4-7987077 |
| Date : | December 17, 2012 |
| Contact person : | Chia-Ching Lee |
| Name of the device : | Syntec Dental Implant |
| Trade or proprietary name : | Syntec Dental Implant |
| Common name: | Dental implant, Dental implant abutments |
| Classification name: | Endosseous dental implant, Endosseous dental implant abutments |
| Produce Code : | DZE, NHA |
| Regulation Number : | 872.3640, 872.3630 |
| Class : | II |
| Predicate device: | Dentium Company Limited Implantium, K041368 |
| Implantium Prosthetics, K052957 |
Description of the Device:
The Syntec Dental Implant provides Titanium Alloy (commercially followed by ASTM F136) intended to be surgically placed in the bone of the upper or lower jaw arches. To provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of implant, cover screw, healing abutment screw and abutments. The Syntec Dental Implant is for one and two stage surgical procedures. Its materials, dimensions, and intended use are similar to devices currently marked worldwide. The range of implant in diameter is from 3.4mm to 4.8mm and in length from 8.0mm to 14.0mm. The range of abutment in diameter is from 4.5mm to 6.5mm, and in length from 5.5mm to 12.0mm.
1
Indications for Use:
The Syntec Dental Implant is intended to be surgically placed in the bone of the upper or lower jaw arches. To provide support for prosthetic devices, such as to restore the patient's chewing function, and artificial teeth. It is intended for delayed loading.
| Predicate Device | Applicant | |
|---|---|---|
| Sponsor | Dentium Co., Ltd. | Syntec Scientific Corporation |
| Device name | Dentium Company Limited Implantium | |
| Implantium Prosthetics | Syntec Dental Implant | |
| 510(k) number | K041368 | |
| K052957 | K111189 | |
| Similarities: | ||
| Regulation number/ | ||
| name/ class/ product | ||
| code | Class II §872.3640, 872.3630/ | |
| Endosseous dental implant, | ||
| Endosseous dental implant abutment/ | ||
| DZE, NHA | Class II §872.3640, 872.3630/ | |
| Endosseous dental implant, | ||
| Endosseous dental implant abutment/ | ||
| DZE, NHA | ||
| Intended for Use | The Dentium Co., Ltd Implantium is intended to be | |
| surgically placed in the bone of the upper or lower jaw | ||
| arches to provide support for prosthetic devices, such as | ||
| artificial teeth, and to restore the patient's chewing | ||
| function. Implantium prosthetics is intended for use as an | ||
| aid in prosthetic rehabilitation. | The Syntec Dental Implant is intended to be surgically | |
| placed in the bone of the upper or lower jaw arches. To | ||
| provide support for prosthetic devices, such as to restore | ||
| the patient's chewing function, and artificial teeth. It is | ||
| intended for delayed loading. | ||
| Diameters of Implant | From 3.4mm to 4.8mm | From 3.4mm to 4.8mm |
| Lengths of Implant | From 8.0mm to 14.0mm | From 8.0mm to 14.0mm |
| Diameters of Abutment | From 4.0mm to 6.5mm | From 4.5mm to 6.5mm |
| Lengths of Abutment | From 5.5mm to 12.0mm | From 5.5mm to 12.0mm |
| Single Use? | Yes | Yes |
| Mechanical Properties | Good | Good |
| Differences: | ||
| Materials | Pure titanium and titanium alloy | Titanium alloy |
| Sterility | Sterile | Implant and cover screw are sterile. Other components are |
| non-sterile. |
Device Comparison Table
2
Bench Testing:
Overview all bench Testing:
| Testing Item | Standard and regulations applied | Submitted on |
|---|---|---|
| Biomechanical testing | ||
| Static strength | ISO 14801 | November 25, 2011 |
| Fatigue testing | ISO 14801 | November 25, 2011 |
| Biocompatibility | ||
| Certificate of Raw material | ISO-10993 | April 26, 2011 |
| Sterilization : | ||
| Sterilization Validation of Gamma Irradiation | ISO 11137 | November 25, 2011 |
| Sterilization Validation of Moist Heat | ISO 17665-1, ISO 17665-2, ISO 11737-1 | November 09, 2012 |
| Sterilization Process Validation | and ISO 11737-2 | |
| surface analysis | ||
| Morphology | SEM | August 7, 2012 |
| Coating thickness | EN ISO 4288 | August 7, 2012 |
| Ca/P ratio | EN ISO 11885-E22 | August 7, 2012 |
| Residue analysis | ASTM F1854/ DIN EN ISO 4288 | August 7, 2012 |
| Cytotoxicity | DIN EN ISO 10993-5 | August 7, 2012 |
| Solubility | FDA guidance (2/21/97) | August 7, 2012 |
| Analysis of raw material | ASTM F1185 and ASTM F1609 | August 7, 2012 |
| Adhesive Tensile Strength | ASTM F-1147 | November 09, 2012 |
| Shear Strength | ASTM F-1044 | November 09, 2012 |
Brief discussion of Biomechanical Studies: The experiments were according ISO 14801 . (Dentistry - Implant - Dynamic Fatigue Test for Endosseous Dental Implants). In these experiments, the static strength and fatigue life were evaluated. The result of Dental Implant is substantially equivalent to predicate devices.
Conclusion:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Syntec concludes that Dental is substantially equivalent to predicate devices as described herein.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
December 20, 2012
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Chia-Ching Lee Regulatory Affairs Specialist Syntec Scientific Corporation 2, Kung San Road Chuan Shing Industrial Zone Shen Kang, Chang Hua Taiwan
Re: K11189
Trade/Device Name: Syntec Dental Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: December 17, 2012 Received: December 19, 2012
Dear Ms. Lee:
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.
4
Page 2 - Ms. Lee
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 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 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Anthony De ma
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
5
INDICATION FOR USE
Indications for Use
510(k) Number (if known): k | | | 89 Device Name: Syntec Dental Implant Indications for Use:
The Syntec Dental Implant is intended to be surgically placed in the bone of the upper or lower jaw arches. To provide support for prosthetic devices, such as to restore the patient's chewing function, and artificial teeth.
AND/OR Over-The-Counter Use x Prescription Use _ (21 CFR 801 Subpart C) ( Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Susan Runner DDS, MA | 2012.12.20
13:32:08 -05'00' |
| ---------------------- | -------------------------------- |
|---|
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K111189 |
|---|---|
| ---------------- | --------- |