(267 days)
No
The summary describes a physical dental implant system and its components, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies focus on material properties and mechanical testing.
Yes.
The device, a dental implant system, is intended to restore a patient's chewing function and support prosthetic devices, which are therapeutic actions.
No
This device is a dental implant system, intended to support prosthetic devices and restore chewing function. It is a therapeutic device, not a diagnostic one, as it does not diagnose a condition or disease.
No
The device description explicitly lists physical components such as dental implants, abutments, occlusal screws, healing caps, and surgical instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for placement in the jaw to support prosthetic devices and restore chewing function. This is a direct therapeutic and restorative function within the body.
- Device Description: The description details physical components like implants, abutments, screws, and surgical instruments. These are all physical devices used in a surgical procedure.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs typically involve analyzing blood, urine, tissue, or other bodily fluids or samples.
- Performance Studies: The performance studies focus on biological evaluation (biocompatibility), mechanical testing (fatigue), and surface analysis. These are relevant to the safety and performance of an implantable device, not a diagnostic test.
In summary, the device is a dental implant system, which is a type of medical device used for surgical implantation and prosthetic support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Dental implant systems are intended to be placed in the upper and lower jaw to support prosthetic devices and to restore a patient's chewing function. Dental implant systems are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
Product codes
DZE, NHA
Device Description
The proposed devices, Dental Implant Systems, are integrated systems of endosseous dental implants, which are intended to support prosthetic devices.
The systems are mainly available in two models which are Tissue Level (TL) and Bone Level (BL), each model consists of the following components: (1) Dental Implants, (2) Abutments, (3) Occlusal Screws and (4) Healing Caps. Each component is available in various configuration. In addition, the systems also consist of various specific surgical instruments.
Abutment models for TL dental implants include: Coping, Solid abutment, Retentive anchor abutment, Screw-retained abutment, Cementable abutment, Angled abutment.
Abutment models for BL dental implants include: Healing Abutment, Anatomic abutment, Meso abutment, Cementable abutment, Multi-base abutment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower jaw
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 tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-3: 2006, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-5,2009:Biological evaluation of medical devices - Part 5: Tests for in vitro Cytotoxicity
- ISO 10993-6 2007, Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
- ISO 10993-10:2002/Amd1:2006, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- ISO 10993-11: 2006, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- ISO 14801:2007, Dentistry - Implants - Dynamic fatigue test for endosseous dental implants
- USP 36-NF31, Bacterial Endotoxins Test
- USP 36-NF31 , Transfusion and Infusion Assemblies and Similar Medical Devices
Electronic speculum and energy spectrum of S-L-A microscopic surface test was conducted on proposed dental implant and predicate dental implant. The test result of scanning electron microscopy showed that there is no significant difference on microscopic morphology of S-L-A of test and controls samples. The test result of surface energy spectrum showed that there is no impurity on both test and control samples surface.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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 consists of a stylized caduceus symbol, which features three human profiles facing right, connected by a flowing ribbon-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 12, 2015
Bio Concept Co., Ltd c/o Ms. Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA
Re: K150388
Trade/Device Name: Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE, NHA Dated: October 9, 2015 Received: October 13, 2015
Dear Ms. Hong:
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 -S
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
2
Indications for Use
510(k) Number (if known) K150388
Device Name Dental Implant System
Indications for Use (Describe)
Dental implant systems are intended to be placed in the upper and lower jaw to support prosthetic devices and to restore a patient's chewing function. Dental implant systems are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: _K150388
- Date of Preparation: 10/27/2015 1.
-
- Sponsor Identification
BIO CONCEPT Co., Ltd
UnitC, No.26, Huashan Middle Road, Xinbei Zone, Changzhou, Jiangsu, 213022, China
Establishment Registration Number: Not yet registered or the Number
Contact Person: Hua Cao Position: General Manager Tel: +86-519-85172266 Fax: +86-519-85172299 Email: xiaojuan.gu@goldenstapler.com
-
- Designated Submission Correspondent
Diana Hong (Primary Contact Person) Lee Fu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Dental Implant System Common Name: Endosseous dental implant Model(s): TL and BL
Regulatory Information
Classification Name: Endosseous implant Classification: II Product Code: DZE Secondary Product Code: NHA; Regulation Number: 21 CFR 872.3640 Review Panel: Dental
Intended Use Statement:
Dental implant systems are intended to be placed in the upper and lower jaw to support prosthetic devices and to restore a patient's chewing function. Dental implant systems are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
Device Description
The proposed devices, Dental Implant Systems, are integrated systems of endosseous dental implants, which are intended to support prosthetic devices.
The systems are mainly available in two models which are Tissue Level (TL) and Bone Level (BL), each model consists of the following components: (1) Dental Implants, (2) Abutments, (3) Occlusal Screws and (4) Healing Caps. Each component is available in various configuration. In addition, the systems also consist of various specific surgical instruments.
Abutment models for TL dental implants include: Coping, Solid abutment, Retentive anchor abutment, Screw-retained abutment, Cementable abutment, Angled abutment.
Abutment models for BL dental implants include: Healing Abutment, Anatomic abutment, Meso abutment, Cementable abutment, Multi-base abutment.
- న్. Identification of Predicate Device(s)
510(k) Number: K123784 Product Name: STRAUMANN DENTAL IMPLANT SYSTEM
5
6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- A ISO 10993-3: 2006, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
-
ISO 10993-5,2009:Biological evaluation of medical devices - Part 5: Tests for in vitro Cytotoxicity
-
ISO 10993-6 2007, Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
-
ISO 10993-10:2002/Amd1:2006, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
-
ISO 10993-11: 2006, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
-
ISO 14801:2007, Dentistry - Implants - Dynamic fatigue test for endosseous dental implants
-
USP 36-NF31, Bacterial Endotoxins Test
-
USP 36-NF31 , Transfusion and Infusion Assemblies and Similar Medical Devices
Electronic speculum and energy spectrum of S-L-A microscopic surface test was conducted on proposed dental implant and predicate dental implant. The test result of scanning electron microscopy showed that there is no significant difference on microscopic morphology of S-L-A of test and controls samples. The test result of surface energy spectrum showed that there is no impurity on both test and control samples surface.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
-
Substantially Equivalent (SE) Comparison 8.
6
| Item | Proposed Device(s) | Predicate Device(s) |
|---|---|---|
| Product Code: | DZE | DZE |
| Regulation #. | 21 CFR 872.3640 | 21 CFR 872.3640 |
| Class | II | II |
| Intended Use | Dental implant systems are intended to be placed in the upper and lower jaw to support prosthetic devices and to restore a patient's chewing function. Dental implant systems are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases. | Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches for the functional and aesthetic oral rehabilitation of edentulous and partially dentate patients. |
| Straumann® Dental implants are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases. | ||
| TL Dental Implants Systems | ||
| Implant Type | Tissue Level | Tissue Level |
| Features | Standard | Standard |
| Standard Plus | Standard Plus | |
| Tapered Effect | Tapered Effect | |
| Neck | Narrow Neck | Narrow Neck |
| Regular Neck | Regular Neck | |
| Wide Neck | Wide Neck | |
| Abutment | Standard / Tapered Effect: | Standard / Tapered Effect: |
| Connection | Internal Morse Taper, Internal Octagonal fixation | Internal Morse Taper, Internal Octagonal fixation |
| Standard Plus | Standard Plus | |
| Surface Treatment | Sand blasting process with large grit and acid-etching (SLA) | Sand blasting process with large grit and acid-etching (SLA) |
| Diameter of Dental Implants | 3.3 mm / 4.1 mm / 4.8mm | 3.3 mm / 4.1 mm / 4.8mm |
| Length of Dental Implants | 8 / 10 / 12 / 14 / 16 mm | 8 / 10 / 12 / 14 / 16 mm |
| Abutment Type | Solid, Angled, Screw-Retained, Cementable, Retentive Anchor | Solid, Angled, Screw-Retained, Cementable, Retentive Anchor |
| Angle | 15°/ 20° | 15°/ 20° |
| BL Dental Implants Systems | ||
| Implant Type | Bone Level | Bone Level |
| Neck | No Neck | No Neck |
| Surface Treatment | Sand blasting process with large grit and acid-etching (SLA) | Sand blasting process with large grit and acid-etching (SLA) |
| Diameter of Dental Implants | 3.3 mm / 4.1 mm / 4.8mm | 3.3 mm / 4.1 mm / 4.8mm |
| Length of Dental Implants | 8.2 / 10.2 / 12.2 / 14.2 mm | 6 / 8 / 10 / 12 / 14 / 16 mm |
| Abutment Type | Solid, Angled, Cementable | Solid, Angled, Cementable |
| Angle | 15°/ 25° | 15°/ 25° |
| Safety | ||
| Dental Implant | Titanium | Titanium |
| Abutment | Titanium Alloy (Ti-6AL-4V) | Titanium Alloy (Ti-6AL-4V) |
| Healing Cap | Titanium Alloy (Ti-6AL-4V) | Titanium Alloy (Ti-6AL-4V) |
| Closure Screw | ||
| Sterilization | ||
| Dental Implant | Provided in sterile condition, sterilized by radiation, SAL 10-6 | Provided in sterile condition, sterilized by radiation, SAL 10-6 |
| Abutment | Provided in non-sterile condition, shall be sterilized by end user prior to operation via autoclave method, SAL 10-6 | Provided in non-sterile condition, shall be sterilized by end user prior to operation via autoclave method, SAL 10-6 |
| Healing Cap | ||
| sure Screw | Provided in non-sterile condition, shall be sterilized by end user prior to operation via autoclave method, SAL 10-6 | Provided in non-sterile condition, shall be sterilized by end user prior to operation via autoclave method, SAL 10-6 |
Table 1 Comparison of Technology Characteristics
7
- Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.