Search Results
Found 3 results
510(k) Data Aggregation
(252 days)
Alpha Dent Implants Dental Implants System is intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications. The prostheses can be screw or cement retained to the abutment.
The Alpha Dent Implants Dental Implants System is indicated also, for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The Alpha Dent Implant Active Conus (IAK), Implant Classic Conus (ICK), Implant Active Bio (IAB) Dental Implants System consists of one or two stage Endosseous form dental implants, with same platform of implant/prosthetics abutments connection- internal hexagon for anti-rotation and internal cone, and It is intended to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.
The Alpha Dent Implants Dental Implants System is a medical device intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous patients. It aims to provide support for prosthetic devices (artificial teeth) and restore chewing function. The system is designed for single-tooth or multiple-teeth applications, with prostheses that can be screw or cement-retained to the abutment. It is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The device's acceptance criteria and the study that proves it meets these criteria are detailed below:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Alpha Dent Implants Dental Implants System are primarily based on demonstrating substantial equivalence to predicate devices (K181138 and K180968) in terms of intended use, materials, performance, and safety. The performance criteria are derived from relevant international standards and the results of non-clinical testing.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance and Evidence |
|---|---|---|
| Intended Use | The device's intended use and indications for use should be substantially equivalent to previously cleared predicate devices. | The subject device's intended use and indications for use are previously cleared by FDA for the reference device K180968 (Alpha Dent Dental Implants Ltd) and are stated to be the same as the primary predicate K181138 (IS-III active System, Neobiotech Co., Ltd). |
| Materials | Implants and prosthetic components must be manufactured from medical-grade materials that comply with relevant standards. | Implants and abutments are manufactured from Titanium alloy (Ti 6Al 4V ELI) complying with ASTM F 136 Standard. This material is consistent with the predicate devices (Ti Grade 5 (Ti6AL4V-ELI) ASTM F136-13 for K180968 and Ti CP4 of ASTM F67 for K181138, though the subject device uses a higher grade Ti alloy). |
| Biocompatibility | The device must demonstrate biocompatibility for its intended use, in accordance with established biological evaluation standards. | Biocompatibility evaluation was conducted in accordance with ISO 10993-1 and FDA guidance. All biological endpoints were met, establishing the device as biocompatible. SEM and Surface analysis (EDS) after the anodize process demonstrated morphology and cleanliness. |
| Sterilization & Packaging | The device must be provided sterile (implants) with a minimum sterility assurance level (SAL) of 10⁻⁶, and packaging must maintain sterility for the specified shelf life. Non-sterile components (abutments) must have validated sterilization instructions for the end-user. | Implants are packaged in a clean room (ISO CLASS 7) and provided with a SAL of 10⁻⁶, validated per ANSI/AAMI/ISO 11137-1 and EN ISO 11137-2. Accelerated aging per ASTM-F-1980 was applied to substantiate a 5-year shelf life, with a real-time study ongoing. Abutments are supplied non-sterile, and moist heat sterilization for end-users was validated per ANSI/AAMI/ISO 17665-1, demonstrating a 6-log reduction of Geobacillus stearothermophilus. |
| Pyrogenicity | The device must meet pyrogen limit specifications. | LAL Endotoxin Analysis demonstrated pyrogenicity met specifications, with a testing limit of 20 EU/device, based on USP . |
| Mechanical Performance | The implants must withstand dynamic fatigue loads per ISO 14801, demonstrating sufficient mechanical strength and durability. Performance should be comparable to the predicate device. For prosthetic components, the implant-abutment connection design and general shape should be similar to recognized predicate devices. The thread type variation for internal thread should not affect structural performance and offer same pitch design. | Static and dynamic compression performance tests were conducted per ISO 14801. The worst-case scenario (smallest diameter, longest implant, 25° abutment) was selected. The measured fatigue limits for Alpha Dent implants were similar to those of the predicate device Neobiotech (K181138) (metal dental implants with a diameter of 3.5 mm). The run-out bending moment was within similar values. The implant/abutment connection design, general shape, and dimensions are compared to predicate K180968. The difference in internal thread type (M1.80-6H vs 1-72 UNF 2B) was deemed not to affect structural performance as both have identical outer diameter (1.80 mm) and same pitch design. |
| Design/Technological Characteristics | The device's technological characteristics, including implant/abutment connection design, surface treatment, general shape, and dimensions, should be comparable to predicate devices. | The implant/abutment connection design (internal hexagon for anti-rotation and internal cone) is stated to be the same as the primary predicate (K181138). The surface treatment (anodized layer), general shape, and dimensions are substantially equivalent to the reference predicate (K180968). While there is a slight difference in design and dimensions between the primary predicate and the subject device, and a minor difference in internal thread type, these were considered not to affect structural performance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific "sample size" in terms of number of devices for each non-clinical test (e.g., how many implants were subjected to fatigue testing). It generally refers to "the implant used in the testing was the smallest in diameter and the longest in length available with this system of implants," indicating a worst-case selection for mechanical performance.
The data provenance is from non-clinical bench testing conducted by Alpha Dent Implants GmbH, not from human or animal subjects. Therefore, there is no information on country of origin of data, or whether it was retrospective or prospective in the sense of clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable. The "test set" in this context refers to non-clinical bench testing data and engineering analysis, not clinical data requiring expert review for ground truth establishment. Equivalence is established through comparison to predicate devices and adherence to international standards.
4. Adjudication Method for the Test Set
This question is not applicable. There was no "test set" of clinical cases requiring adjudication by experts. The substantiation relies on engineering judgment, comparison to predicate devices, and demonstrated compliance with recognized standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The document explicitly states: "No clinical studies were performed." This is a 510(k) submission primarily relying on substantial equivalence to legally marketed predicate devices through non-clinical performance testing and comparative analysis of design and materials.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable. The Alpha Dent Implants Dental Implants System is a physical medical device (dental implants and associated prosthetic components), not an AI algorithm or software. Therefore, there is no "standalone" algorithm performance to assess.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating the safety and effectiveness of the device is established by:
- Substantial Equivalence to Predicate Devices: Comparing the new device's intended use, technological characteristics (design, materials, surface treatment), and performance data to those of one or more legally marketed predicate devices (K181138 and K180968) that have already been determined safe and effective.
- Adherence to Recognized International Standards: Compliance with standards such as ASTM F 136 (material), ISO 10993-1 (biocompatibility), ANSI/AAMI/ISO 11137-1 and EN ISO 11137-2 (sterilization), USP (pyrogenicity), ASTM-F-1980 (accelerated aging/shelf life), and ISO 14801 (dynamic fatigue test for implants).
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of this device submission, as it is a physical medical device and not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as point 8.
Ask a specific question about this device
(142 days)
Kontact™ Dental Implant System is indicated for use in partially or fully edentulous patients to support maxillary or mandibular single unit, multiple-unit, or overdenture dental restorations. Kontact Dental Implant System is indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate. Kontact 3 mm diameter implants and prosthetics components are indicated for use in surgical and restorative applications in the maxillary lateral incisor or mandibular incisor regions.
The Kontact™ Dental Implant System comprises endosseous root-form dental implants, abutments, abutment screws, and other associated components for single-unit, multi-unit, and overdenture restorations. Kontact dental implants are provided in five body diameters: 3.0 mm, 3.6 mm, 4.2 mm, 4.8 mm, and 5.4 mm. The platform diameter for each size is the same as the (maximum) body diameter. The implants are provided in lengths ranging from 8 mm to 16 mm. The implants have a recessed internal section for abutment indexing, and an internal threaded section for mating to the corresponding subject device cover screw, or abutment screw. All implants are manufactured from titanium alloy conforming to ASTM F136 and ISO 5832-3. The endosseous threaded surface of the subject device implants is grit-blasted with non-resorbable aluminum oxide (Al2O3) particles. Kontact conventional and prosthetic components include cover screws, abutment screws, temporary abutments, straight abutments, angled abutments, prepable abutments, multi-unit abutments, healing caps, and overdenture abutments. Most device screws and all subject device abutments are manufactured from titanium alloy conforming to ASTM F136 and ISO 5832-3. Select subject device abutments and screws manufactured from titanium alloy are anodized using standard electrolytic passivation processing to impart a distinctive surface color. The subject device abutment screw intended for 3 mm diameter implants and the prosthesis screw intended for conical abutments are manufactured from cobalt alloy, conforming to ASTM F1058 and ISO 5832-7. The abutment screw is coated with titanium nitride (TiN); the prosthesis screw is coated with chromium nitride (CrN). Subject device healing caps intended for use with UniPost abutments, and IsoPost abutments are manufactured from polyetheretherketone (PEEK). Subject device healing caps intended for NanoPost abutments and IsoPost abutments are manufactured from polymethyl methacrylate (PMMA).
The product, Kontact™ Dental Implant System, has not reported any clinical studies. The only data provided is non-clinical performance data.
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Evaluation Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Conformance to ISO 10993-5 and ISO 10993-12 | Device demonstrates biocompatibility according to ISO 10993-5 (tests for in vitro cytotoxicity) and ISO 10993-12 (sample preparation and reference materials). Specific results are not detailed but compliance with these standards indicates meeting requirements for biological safety. |
| Gamma Sterilization | Conformance to ISO 11137-1 and ISO 11137-2 | Validation performed for subject device implants and cover screws. Specific Sterility Assurance Levels (SAL) are not stated, but conformance to these standards implies achieving a validated sterile state (e.g., SAL of 10^-6). |
| Bacterial Endotoxin Testing (BET) | ≤ 20 EU/device | Limulus amebocyte lysate (LAL) test performed according to ANSI/AAMI ST72 and USP 43-NF38:2020 . Ongoing monitoring and control ensure BET levels meet or are below ≤ 20 EU/device. This indicates the devices are free from pyrogenic contamination within accepted limits. |
| Shelf Life Validation | Conformance to ASTM F1980 and ISO 11607-1 | Packaging stability validated. Conformance to ASTM F1980 (standard guide for accelerated aging of sterile medical device packages) and ISO 11607-1 (packaging for terminally sterilized medical devices) indicates the device maintains its integrity and sterility over its claimed shelf life. Specific shelf life duration is not provided. |
| Moist Heat Sterilization (End-user) | Conformance to ISO 17665-1 and ISO TS 17665-2 | Instructions and validation for end-user moist heat sterilization provided. Conformance to ISO 17665-1 (sterilization of health care products - moist heat - requirements for the development, validation and routine control of a sterilization process for medical devices) and ISO TS 17665-2 (guidance on the application of ISO 17665-1) ensures proper sterilization by the end-user. Specific parameters are not detailed. |
| Static Compression & Compression Fatigue Testing | Conformance to ISO 14801 | Mechanical performance testing performed on the subject device according to ISO 14801 (dentistry - implants - dynamic fatigue test for endosseous dental implants). The fatigue limit data for abutments compatible with 3.0 mm diameter implants was supported by reference device K183518, and "constructs of all other subject device abutments in combination with all other subject device implants have sufficient strength for their intended use." This indicates the devices meet mechanical strength requirements for their intended application. The specific criteria for "sufficient strength" are not explicitly quantified (e.g., number of cycles survived, load at failure) but implied by conformance to the standard. |
| Endosseous Surface Characterization | Demonstrated by SEM and EDS | The grit-blasted surface (with non-resorbable aluminum oxide) was validated by scanning electron microscope (SEM) and energy dispersive X-ray spectroscopy (EDS) characterization. This confirms the presence and composition of the surface modification intended to facilitate osseointegration. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for any of the non-clinical tests.
- Data Provenance: All data is non-clinical and derived from laboratory testing of the device and its components, primarily referencing international and industry standards (ISO, ASTM, ANSI/AAMI, USP). Information on the country of origin of the test data is not provided, but the manufacturer is Biotech Dental, SAS, based in France. The data is retrospective in the sense that it's generated as part of a premarket submission, not from a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This device relies on pre-defined engineering and sterility standards, not expert-established ground truth from clinical cases. There were no clinical studies.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Not applicable. There was no test set for clinical performance requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- Not applicable. No clinical studies were conducted, and this product does not involve AI or human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This product is a physical dental implant system, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
- Not applicable. Ground truth, in the clinical sense, was not used as there were no clinical studies. The "ground truth" for non-clinical testing is adherence to established international and industrial standards (e.g., ISO, ASTM) for material properties, mechanical performance, and sterility.
8. The Sample Size for the Training Set
- Not applicable. There was no training set, as this is a physical medical device and not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There was no training set.
Ask a specific question about this device
(290 days)
Surgikor's Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The 7mm implants are intended to be used in the molar region.
The Surgikor Dental Implant System consists of two stage endosseous form dental implants, hexagonal and conical implants and hexagonal and conical abutments; cover screws and healing caps; abutment systems including multi-unit abutments. Implants are made from Ti6ALAV ELI.
The Surgikor Dental Implant System includes:
Versatile model is a platform switched, tapered implant designed for use in any bone type and is offered with a Morse tapered hex connection. The regular hex platform comes in diameters of 3.5, 3.75, 4.2, 4.5, 5.0 and 6.0mm. Lengths of 8, 10, 11.5, 13 and 16 are available with 18 and 20 mm lengths available in the 4.2 diameter only.
Immediate model is a platform switched root-form implant design. The Immediate suitable for both immediate load applications and insertion into fresh extraction sockets and is offered with a Morse tapered hex connection in regular platform. It is available in 3.75, 4.2, 4.5, 5.0, 6.0, and 7.0 mm diameter. The hex is regular platform and comes in lengths of 7 (4.5, 5, 6.and 7mm only), 8, 10, 11.5, 13, 16 (7.0mm diameter not in 11.5,13 or 16 mm length).
Fixation model is a root form implant is appropriate for both immediate load applications and insertion into fresh extraction sockets. The Fixation is offered with a conical connection in narrow, regular and wide platforms. The 3.0 diameter implant is available in narrow platform and lengths of 10, 11.5, 13 and 15mm. The Fixation regular platform implant is available in 3.5 and 3.9 mm diameter and has available lengths of 8.5, 10, 11.5, 15, and 18 mm. Wide platform is available in 4.3 and 5.0 mm diameter with lengths of 8.5, 10, 11.5, 13, 15 and 18mm.
Solution model is equipped with a specially designed, narrow, deep, conical connection and is designed for use in narrow bone volumes. The Solution5 is available in narrow platform with a diameter of 3.25mm and lengths of 10, 11.5, 13, 15 mm. The regular platform is available in 3.5, and 4.0 diameter in lengths of 7.0 (4.0 diameter only), 8.5, 10. 11.5, 13, 15mm. The wide platform is available in diameters of 4.5. 5.0. 5.5 and 6.0mm. These diameters come in lengths of 7.0. 8.5. 10. 11.5. 13. and 15mm. The Solution2 is available with lengths of 10. 11.5. 13. and 16 mm in a diameter of 3.25 mm. The Solution5 and Solution2 differ in that the Solution5 implants have an outer thread like the Versatile model, while the Solution2 have an outer thread like the Immediate model.
Healing caps are available in 3 platform sizes: normal, narrow and wide. The conical connection models are available in narrow, regular and wide platforms with lengths of 2, 3, 4, 5, 6, 7 mm and diameters of 3.0, 3.5 and 4.3 mm. There is also a wide platform conical connection healing cap for both narrow emergence and wide emergence. These are 4.3 mm diameter in lengths of 2, 3, 4, 5, 6 and 7 mm. The hex connection models are available in narrow emergence, regular platform with lengths of 2. 3. 4. 5. 6. 7 mm and a diameter of 3.75 mm and standard & wide emergence regular platform with lengths of 2,3, 4, 5, and 6 mm and a diameter of 3.75 mm. There is also a healing cap for the multiunit abutment which comes in one size. Healing caps with marks for scanning are available in 2mm length for regular hex, narrow conical, regular conical and wide conical platforms.
Temporary abutment is for immediate loading if appropriate. The Temporary abutment is available with a conical connection in narrow, regular and wide platforms all with lengths of 1, 2, 3, 4, 5, 6 and 7 mm and diameters of 3.0, 3.5 and 4.3 mm. It is also available with a hex connection regular platform with lengths of 1, 2, 3, 4, 5, 6, 7 mm and a diameter of 3.75 mm.
Non-shouldered abutments are straight titanium abutments with hex designed for permanent restoration. The abutments are supplied as regular non-shouldered straight abutments with lengths of 5, 7, 9, 12 and 15 (not in narrow conical) mm with a narrow conical platform of 3.0 mm width, a regular conical platform of 3.5 mm width, a wide conical platform of 4.3mm and with a regular hex platform of 3.75 mm width. Also available is a wide emergence non-shouldered straight abutment with lengths of 5, 7, 9, 12 and 15 mm with a wide conical platform of 4.3 mm. The 5mm height nonshouldered abutments are intended for multiple unit restorations only.
15° and 25° angular non-shouldered abutments: 15° abutments are supplied in lengths of 9, 11 and 13 mm with either a hex connection (3.75mm) or a conical connection in narrow (3.0mm), regular (3.5mm) or wide (4.3mm) platform. 25° abutments are supplied in lengths of 9, 11 and 13 mm with a hex connection, a conical connection regular platform or a conical connection wide platform. 15° and 25° narrow emergence abutments are supplied as a hex connection regular platform with a width of 3.75 mm. 15° and 25° wide emergence abutments are supplied as a wide platform conical connection with a width of 4.3 mm and lengths of 9, 11, and 13mm.
Anatomic Straight Shouldered Abutments All have a length of 7.5mm and shoulder heights of 1, 2 and 3 mm. They are available in the following configurations: conical connection, narrow, regular or wide platform or hex connection regular platform. Wide emergence versions are available in wide conical connection and regular hex connection.
15°, and 25° Angled Anatomic Abutment with Shoulder, all have a length of 7.5 mm and shoulder heights of 1, 2 and 3 mm. They are available in conical connection, narrow (available in 15° only), regular and wide platform and hex connection regular platform. Wide emergence version are available in wide conical.
Ball Attachment Abutments are provided with lengths of 1, 2, 3, 4, 5, and 6 mm and in the following configurations: Conical connection, narrow platform 3.0 mm diameter, Conical connection, regular platform 3.5 mm diameter, Conical connection, wide platform 4.3 mm diameter , Hex connection, regular platform 3.75 mm diameter. Ball attachment abutments are intended for multiple unit restorations only.
Multi-Unit Abutment are supplied with lengths of 1, 2, 3 and 4 mm. They are available in narrow regular and wide conical platforms and in hex regular platform. An angled multi-unit of either 18° or 30° is available for conical connections of narrow, regular and wide platform. A plastic sleeve for casting an extension for using multi-units in single units is included in the 510k. Multi-unit abutments are intended for multiple unit restorations only.
Standard Locator Abutments are supplied in shoulder heights of 1, 2, 3, 4, 5, and 6mm. Locators are intended for multiple unit restorations only.
Castable abutments are available in hexed and non-hexed in hex or conical connection (all three platforms). They are available in Ti alloy and gold. A plastic sleeve is available for use with the castable abutments. They are intended for casting straight abutments taller than 4mm.
Abutment Screws are available for hex connection and for all three platforms of conical connection.
Cover Screw are supplied with a conical connection as narrow, regular and wide and with a hex connection.
The provided text is a 510(k) summary for the Surgikor Dental Implant System, detailing its substantial equivalence to predicate devices. However, it does not describe an AI/ML device or a study proving its performance against acceptance criteria in the context of an AI/ML system.
The document focuses on the physical characteristics, materials, and mechanical testing of dental implants and their associated components (abutments, healing caps, etc.). The "Testing Summary" refers to:
- Dynamic fatigue testing according to ISO 14801: This is a standard for evaluating the fatigue strength of dental implants. The acceptance criterion is "Sufficient run out load for their intended use."
- Surface cleanliness analysis: "all tests were passed."
- Biocompatibility of materials (gold for UCLA abutments, CoCr for castable abutments): "was shown to be biocompatible."
- Sterilization according to ISO 11137-1 and 11137-2: "was conducted on the implants."
- Abutment steam sterilization according to ISO 17665-1 and -2: "was done."
- Material conformity to ASTM F136.
- Endotoxin testing according to USP 161: "was conducted."
These are standard regulatory requirements for medical devices and do not relate to the performance of an AI/ML algorithm.
Therefore, I cannot provide the requested information for an AI/ML device, as the document does not discuss such a device or its associated studies.
Ask a specific question about this device
Page 1 of 1