Not Found
No
The summary describes a dental implant system and its components. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on mechanical testing, not algorithmic performance.
No
This device is a dental implant system, which is a prosthetic device used to replace missing teeth, not a therapeutic device designed to treat a disease or condition. It provides support for crowns, bridges, or overdentures.
No
The device is an implant system used for supporting crowns, bridges, or overdentures. It is a therapy device that is surgically implanted, not a diagnostic device that detects or diagnoses a disease/condition.
No
The device description clearly outlines physical components made of titanium and polyetheretherketone, which are hardware. The performance studies also focus on mechanical testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The iSy® Implant System is a dental implant system designed to be surgically placed in the bone of the jaw and used to support dental restorations like crowns and bridges. It is a physical device used in vivo (within the body), not a test performed on a sample in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the iSy® Implant System falls under the category of a surgical implant and restorative dental device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
iSy® Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. iSy Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.
Product codes
DZE, NHA
Device Description
The iSy Implant System is an endosseous dental implant system designed for ease of use. Each product package contains the components needed for implant placement, impression taking, gingival contouring, and temporization. Components available with the iSy Implant System include the implant base, cover cap, multifunctional cap, gingiva former, universal abutment and Titanium base CAD/CAM. The implants are provided in three diameters (3.8, 4.4 and 5.0 mm) and three lengths (9, 11, and 13 mm). The implant/abutment interface is identical for all sizes and, therefore, only one abutment connection is necessary. The implant base is a mount, supplied with the implant, that also can be used for temporary restoration. Titanium base CAD/CAM is an abutment designed to be used with the Sirona CAD/CAM System in Coris ZI meso L and meso S to fabricate a hybrid abutment with an angle up to 20°. The cover cap, multifunctional cap and gingiva former are temporary abutments used during healing. The universal abutment and titanium base CAD/CAM are abutments used for final restoration. The iSy implants are made of unalloyed titanium, iSy implant base, universal abutment and Titanium base CAD/CAM are made of titanium alloy, and iSy cover cap, multifunctional cap and gingiva former are made of polyetheretherketone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular arch
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 submitted, referenced, or relied upon to demonstrate substantial equivalence included: engineering analysis, dimensional analysis, and static and dynamic compression-bending testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. Clinical data were not submitted in this premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K113779, K083496, K120414, K111421
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.
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus-like symbol with three human profiles merging into a single form, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The seal is simple, using black lines on a white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 6, 2014
Altatec GmbH C/O Ms. Linda K. Schulz, BSDH, RDH PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130
Re: K133991
Trade/Device Name: iSy® Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: July 3, 2014 Received: July 7, 2014
Dear Ms. Schulz:
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
Page 2 - Ms. Schulz
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,
Mary S. Runner -S
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
2
Indications for Use
K133991 510(k) Number:
Device Name: iSy® Implant System
iSy® Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. iSy Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
Page 1 of 1
Sheena A. Green -S 2014.08.06 12:14:27 -04'00'
3
510(k) Summary
Altatec GmbH iSy® Implant System K133991
August 5, 2014
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Altatec GmbH
Maybachstrasse 5
D-71299 Wimsheim, Germany |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| | Telephone: +49 7044 9445 0 |
| | Fax: +49 7044 9445 723 |
| Official Contact | Tina Steffanie-Oak,
Supervisor, Regulatory Operations |
| Representative/Consultant | Linda K. Schulz, BSDH, RDH
Kevin A Thomas, PhD
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130 |
| | Telephone: +1 (858) 792-1235 |
| | Fax: +1 (858) 792-1236 |
| | Email: lschulz@paxmed.com |
| | kthomas@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | iSy® Implant System |
|---|---|
| Common Name | Endosseous dental implant |
| Classification Name | Implant, endosseous, root form |
| Endosseous dental implant abutment | |
| Classification Regulations | 21 CFR 872.3640, Class II |
| Product Code | DZE, NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
4
INTENDED USE
iSy® Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. iSy® Implant System Abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.
DEVICE DESCRIPTION
The iSy Implant System is an endosseous dental implant system designed for ease of use. Each product package contains the components needed for implant placement, impression taking, gingival contouring, and temporization. Components available with the iSy Implant System include the implant base, cover cap, multifunctional cap, gingiva former, universal abutment and Titanium base CAD/CAM. The implants are provided in three diameters (3.8, 4.4 and 5.0 mm) and three lengths (9, 11, and 13 mm). The implant/abutment interface is identical for all sizes and, therefore, only one abutment connection is necessary. The implant base is a mount, supplied with the implant, that also can be used for temporary restoration. Titanium base CAD/CAM is an abutment designed to be used with the Sirona CAD/CAM System in Coris ZI meso L and meso S to fabricate a hybrid abutment with an angle up to 20°. The cover cap, multifunctional cap and gingiva former are temporary abutments used during healing. The universal abutment and titanium base CAD/CAM are abutments used for final restoration. The iSy implants are made of unalloyed titanium, iSy implant base, universal abutment and Titanium base CAD/CAM are made of titanium alloy, and iSy cover cap, multifunctional cap and gingiva former are made of polyetheretherketone.
EQUIVALENCE TO MARKETED DEVICE
Altatec GmbH submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, iSy® Implant System is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
Altatec GmbH, CONELOG® Implant System cleared under K113779;
Altatec GmbH, CAMLOG Implant System Modified Implants and Abutments cleared under K083496;
Astra Tech AB, OsseoSpeed™ Plus cleared under K120414; and
Sirona Dental Systems GmbH, Sirona Dental CAD/CAM System cleared under K111421.
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: engineering analysis, dimensional analysis, and static and dynamic compression-bending testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. Clinical data were not submitted in this premarket notification.
The subject device and the predicate devices encompass the same range of physical dimensions and characteristics, including implant diameter and length, and similar surface treatments. Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy.
5
| | Subject
Device | Predicate Devices | | | |
|---------------------------------|--------------------------------|----------------------------|-------------------------------------------------------------------|--------------------------------------------------|------------------------------------|
| | Altatec GmbH | Altatec GmbH | Altatec GmbH | Astra Tech AB | Sirona Dental
Systems GmbH |
| | iSy® Implant
System | CONELOG®
Implant System | CAMLOG
Implant System
Modified
Implants and
Abutments | OsseoSpeed™
Plus | Sirona Dental
CAD/CAM
System |
| | | K113779 | K083496 | K120414 | K111421 |
| Design | | | | | |
| Implant
Length, mm | 9- 13 | 7.0- 16 | 9.0 - 16 | 6 - 17 | NA |
| Implant
Diameter, mm | 3.8- 5.0 | 3.3- 5.0 | 3.3- 6.0 | 3.0 - 5.4 | NA |
| Abutment
Diameter, mm | 6.5 | 3.3 - 5.0 | 3.3- 6.0 | 3.0 - 5.4 | 3.3 - 6.5 |
| Abutment Angle | Straight, up to
20° | Straight, up to
30° | Straight up to
20° | Straight, up to
30° | Straight, up to
20° |
| Material | | | | | |
| Implant | CP Ti Gr 4 | CP Ti Gr 4 | CP Ti Gr 4 | CP Ti Gr 4 | NA |
| Abutments and
Abutment Screw | Titanium
Alloy;
Zirconia | Titanium Alloy | Titanium Alloy;
Zirconia | Titanium Alloy;
Zirconia, Gold
alloy, PEEK | Titanium Alloy;
Zirconia |
| Implant Surface | GBE | GBE | GBE | GBE | NA |
Overall, iSy® Implant System has the following similarities to the predicate devices:
- has the same intended use,
- uses the same operating principle,
- incorporates the same basic design, ●
- incorporates the same or very similar materials, and .
- has similar packaging and is sterilized using the same materials and processes. .
The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.