(310 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 dentures, in edentulous 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.
Superior Active and Active Bio Plus are a conical-shaped implant with a helical aggressive thread. It is used under one- or two-steps procedure in all bone types. The implant has a platform with an inner cone and a hexagon for positioning.
Superior Active and Active Bio Plus consist of the implant itself and a cover screw, which are packed in a titanium cuff filled with isotonic sodium chloride solution and a plastic flask.
The implant surface treatment method, known as Sandblasted, Large Grit, Acid-Etched (SLA), is a technique designed to roughen the surface of dental implants. The SLA process consists of two key steps: sandblasting with large grit particles to create a roughened texture, followed by acid etching to refine the surface.
The implant WET packaging process involves placing the implant in a protective titanium sleeve within a vial filled with NaCl 0.9% solution. The vial is sealed with a lid and placed inside a blister package. Both the plastic vial and the blister package serve as sterile barriers.
Additional abutments to the already submitted abutments in K210499: The abutments are anodized. Healing caps for implants with conical connection and Anatomical Titanium Shoulder Abutments and Healing caps for Multi-Unit System are also described.
This document pertains to a 510(k) submission for the Alpha Dent Implants Dental Implants System (K240435). It details the device, its intended use, and a comparison to predicate devices to establish substantial equivalence.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data. It explicitly states: "No clinical studies were performed." Therefore, there is no information about a "study that proves the device meets acceptance criteria" in terms of clinical performance, sample sizes for test sets in clinical trials, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these typically relate to clinical efficacy/effectiveness or AI/software performance, neither of which are the primary focus of this specific 510(k) for a dental implant system.
The "acceptance criteria" discussed below are related to the non-clinical performance testing conducted to support the substantial equivalence claim.
Acceptance Criteria and Device Performance (Non-Clinical)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance (Summary) |
|---|---|---|---|
| Mechanical Strength | ISO 14801:2016 Dentistry — Implants Dynamic loading test for endosseous dental implants | Subject device (IABP & ISPA) performance must be substantially equivalent to predicate devices. | Mechanical strength testing was conducted on "worst-case scenario" (25-degree abutment angulation, 3.3mm diameter implant). Results indicated substantial equivalence to predicate devices. |
| Surface Cleanliness/Biocompatibility | SEM/EDX analysis for cleanliness; ISO 10993-1:2018 (Biological evaluation of medical devices); USP<85> / ANSI/AAMI ST72 (Pyrogenicity) | No harmful alumina or chemicals remaining on implant surface; Biocompatibility per ISO 10993-1; Pyrogen limit of 20 EU/device (LAL method). | SEM/EDX showed no harmful residues, only slight NaCl traces. Biocompatibility (cytotoxicity) conducted per ISO 10993-5 (including aged implants) confirmed no adverse effects. Pyrogenicity testing met the 20 EU/device limit. |
| Hydrophilicity | Contact angle measurements (standardized water drop test with isotonic saline); Qualitative observation of droplet distribution rate | Contact angle below 90° for hydrophilicity; smaller angle for greater wettability. | Non-aged implant: 34° contact angle (hydrophilic). 2-year-aged implant: 0° contact angle (complete wetting, maximal hydrophilicity). Rapid spread of droplet observed. |
| MR Compatibility | FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" | Magnetically induced displacement force and torque suitable for MRI environment. | Non-clinical worst-case MRI review performed based on scientific rationale and published literature. Rationale addressed parameters per FDA guidance. |
| Packaging Integrity | ISO 11607-1:2019, Packaging for terminally sterilized medical devices | Packaging must maintain sterility and product integrity. | Packaging performance testing conducted according to ISO 11607-1. |
| Sterilization Validation | ANSI/AAMI/ISO 11137-1 and EN ISO 11137-2 | Sterility Assurance Level (SAL) of 10^-6 must be achieved. | Test results demonstrated SAL of 10^-6 was achieved and all testing requirements were met. |
| Shelf Life | ASTM-F-1980 (Accelerated Aging) | Packaging integrity, cytotoxicity, and hydrophilicity maintained over claimed shelf life. | Accelerated aging completed for 2-year shelf-life claim. Extended 5-year study ongoing based on these criteria. |
Study Details (Non-Clinical Performance Testing)
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact number of units tested for each non-clinical test (e.g., how many implants were tested for mechanical strength, how many samples for SEM/EDX, etc.). It states that "worst-case scenario" samples were tested for mechanical strength (e.g., "Implant Active Bio Plus (IABP)3.3x13 and Implant Superior Active(ISPA)3.5x13, along with Angulated Titanium Abutment 25 ° angulation").
The data provenance is from non-clinical laboratory testing conducted by the manufacturer (Alpha Dent Implants GmbH, based in Germany) or outsourced laboratories, as part of the 510(k) submission process. This is retrospective in the sense that the testing was performed before the submission for premarket review.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable in the context of this 510(k) submission. "Ground truth" established by experts in this context would typically refer to clinical or diagnostic evaluation (e.g., radiologist reads for AI models), which are explicitly stated as "No clinical studies were performed." The "ground truth" for the non-clinical tests are objective measurements based on established engineering and materials science standards (e.g., forces measured, chemical analysis).
4. Adjudication Method for the Test Set:
Not applicable, as this refers to clinical evaluation or expert consensus, not non-clinical performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. The document explicitly states "No clinical studies were performed." Therefore, no MRMC study was conducted or reported.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a dental implant system, not a software algorithm or AI.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical performance testing is based on objective measurements from laboratory tests against established industry standards (e.g., ISO, ASTM, USP). For example, mechanical strength is measured against the failure loads defined by ISO 14801, surface properties are observed and measured via SEM/EDX and contact angle, and biocompatibility is assessed by established protocols like ISO 10993.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable. This is not an AI/ML device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Alpha Dent Implants GmbH Simha Sibony RA/OA Consultant Hanauer Street 8 Pforzheim, 75181 GERMANY
December 20, 2024
Re: K240435
Trade/Device Name: Alpha Dent Implants Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 5, 2024 Received: December 2, 2024
Dear Simha Sibony:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Alpha Dent Implants Dental Implants System
Indications for Use (Describe)
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 dentures, in edentulous 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 Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo consists of the Greek letter alpha on the left, followed by the words "ALPHA DENT" in large, bold letters. Below "ALPHA DENT" is the word "IMPLANTS" in smaller letters. The logo is gray.
ALPHA DENT IMPLANTS Hanauer Straße, 8 75181 Pforzheim
510K SUMMARY - K240435
ALPHA DENT SUPERIOR ACTIVE AND ACTIVE BIO PLUS IMPLANTS (ISPA AND IABP)
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Alpha Dent Implants Dental Implants System
| Date prepared: | 20th December 2024 | |
|---|---|---|
| Device name: | Alpha Dent Implants Dental Implants System | |
| Common Name: | Endosseous Dental Implant | |
| Classification Name: | Implant, Endosseous, Root-Form | |
| Class: | II | |
| Product Code: | DZE | |
| Subsequent productcode | NHA | |
| CFR section: | 21 CFR§872.3640 and 21 CFR§872.3630 | |
| Device panel: | Dental | |
| Legally MarketedPrimary PredicateDevice: | K210499 – Alpha Dent Implants GmbH | |
| Legally MarketedReference Devices: | K200102-MIS Implants | |
| Submitter: | Dr Boris Simanovski — CEOAlpha Dent Implants GmbHHanauer Straße 8, 75181 Pforzheim, GermanyE: dr.simanovski@gmail.comTel: +4917678531156 | |
| Contact: | Simha Sibony- Regulatory Affairs ConsultantGMRE LtdC/O Alpha Dent Implants GmbHHanauer Straße 8, 75181 Pforzheim, GermanyEmail: simha@globalmre.com |
GENERAL INFORMATION 1.
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Image /page/5/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features the greek letter alpha on the left. To the right of the greek letter is the text "ALPHA DENT" in a sans-serif font. Below the text "ALPHA DENT" is the text "IMPLANTS" in a smaller font.
.alpha-dent.net
2. DEVICE DESCRIPTION
2.1 DENTAL IMPLANT SUPERIOR ACTIVE-ISPA AND ACTIVE BIO PLUS -IABP
Superior Active and Active Bio Plus are a conical-shaped implant with a helical aggressive thread. It is used under one- or two-steps procedure in all bone types. The implant has a platform with an inner cone and a hexagon for positioning.
Superior Active and Active Bio Plus consist of the implant itself and a cover screw, which are packed in a titanium cuff filled with isotonic sodium chloride solution and a plastic flask.
The implant surface treatment method, known as Sandblasted, Large Grit, Acid-Etched (SLA), is a technique designed to roughen the surface of dental implants. The SLA process consists of two key steps: sandblasting with large grit particles to create a roughened texture, followed by acid etching to refine the surface.
The implant WET packaging process involves placing the implant in a protective titanium sleeve within a vial filled with NaCl 0.9% solution. The vial is sealed with a lid and placed inside a blister package. Both the plastic vial and the blister package serve as sterile barriers.
2.2 ADDITIONAL ABUTMENT TO THE ALREADY SUBMITTED ABUTMENTS IN K210499:
The abutments are anodized.
Healing caps for implants with conical connection:
HCWK 3/7 -WIDE HEALING CAP, conical connection Diameter: 5.5 mm Length: 7 mm HCWK - WIDE HEALING CAP, conical connection Diameter: 6.5/8.0 mm Length: 3/4/5 and 7 mm
Anatomical Titanium Shoulder Abutments
TAK 3/004 – Titanium Abutment Konus Shoulder: Diameter: 4.2 mm Length: 4 mm
Healing caps for Multi-Unit System
HCAEK: Diameter: 4.7 mm Length: 5.8 mm HCAEM: Diameter: 4.3 mm Length: 5 mm
HCAEM-W: Diameter: 6.2 mm Length: 5 mm
3. MATERIALS
The implants are manufactured from Chemically Pure(CP)Ti Grade 4 complying with standard ASTM F 67 Standard Specification for Unalloyed Titanium, for Surgical Implant Applications .
The Material for abutments- Ti6Al4V-ELI complying with standard ASTM F136.
4. INDICATION FOR USE
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Image /page/6/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo consists of the Greek letter alpha followed by the words "ALPHA DENT" in a bold, sans-serif font. Below "ALPHA DENT" is the word "IMPLANTS" in a smaller font.
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.
5. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES
| Subject Device | Primary Predicate Device | Reference Device | Subject Device – Alpha DentImplants Dental Implants System(K240435) | Alpha Dent Implants Dental Implants System is intended for surgicalplacement in the maxillary and/or the mandibular arch, to supportcrowns, bridges, or over dentures, in edentulous patients. It isintended to provide support for prosthetic devices, such as artificialteeth, and to restore the patient's chewing function. The System isintended to be used in either single tooth or multiple teethapplications. The prostheses can be screw or cement retained to theabutment.The Alpha Dent Implants Dental Implants System is indicated also forimmediate loading when good primary stability is achieved and withappropriate occlusal loading. |
|---|---|---|---|---|
| ISPA – Implant Superior Active | Alpha Dent Dental ImplantsSystem, K210499 | MIS Dental Implant System,K200102 | Primary Predicate Device – AlphaDent Implants Dental ImplantsSystem (K210499) | Alpha Dent Implants Dental Implants System is intended for surgicalplacement in the maxillary and/or the mandibular arch, to supportcrowns, bridges, or over dentures, in edentulous patients. It isintended to provide support for prosthetic devices, such as artificialteeth, and to restore the patient's chewing function. The System isintended to be used in either single tooth or multiple teethapplications. The prostheses can be screw or cement retained to theabutment.The Alpha Dent Implants Dental Implants System is indicated also forimmediate loading when good primary stability is achieved and withappropriate occlusal loading. |
| IABP – Implant Active Bio Plus | Alpha Dent Dental ImplantsSystem, K210499 | MIS Dental Implant System-K200102 | Reference Device – MIS DentalImplant System (K200102) | MIS Dental Implant Systems are intended to be surgically placed inthe bone of the upper or lower jaw arches to provide support forprosthetic devices, such as artificial teeth, in order to restoremasticatory function. When a one-stage surgical procedure isapplied, the implant may be immediately loaded when goodprimary stability is achieved, and the occlusal load is appropriate.Narrow implants (03.3mm) are indicated for use in surgical andrestorative applications for placement only in the mandibularcentral, lateral incisor and maxillary lateral incisor regions ofpartially edentulous jaws, to provide support for prosthetic devicessuch as artificial teeth. Mandibular central and lateral incisors mustbe splinted if using two or more narrow implants adjacent to oneanother.The long MIS (18 & 20 mm) implants can be used in a tiltedmanner.MIS short implants are to be used only with straight abutments. M4short implants are indicated for delayed loading only. |
Alpha Dent Implants Dental Implants System - IABP and ISPA subject to this submission are substantially equivalent to K210499 AlphaDent Implants GmbH in terms of intended use, implant/abutment connection design, platform diameter and surface treatment.
The detailed comparison analysis indicates substantial equivalence between Alpha Dent Superior Active and Active Bio Plus implants (ISPA and IABP) and MIS Dental Implant System in WET packaging, prosthetic connection, device classification, intended use, surface treatment, surface morphology, size of craters/pores, biological characteristics, design and dimensions, inner package medium and sterilization method.
Comparison Details:
- IABP and ISPA Implants are classified as "Implant, Endosseous dental implants," indicating the same primary purpose in dental implantology as a primary predicate K210499 AlphaDent Implants.
- The intended use IABP and ISPA Implants is identical to primary predicate K210499 AlphaDent Implants, supporting single or multiple teeth applications and immediate loading under appropriate conditions.
- . IABP and ISPA Implants' material biocompatibility and duration of use/contact with the body are identical to primary predicate K210499 AlphaDent Implants.
- . Inner package medium and sterilization method are similar to K200102 MIS Implants, utilizing NaCl solution and gamma irradiation.
5.1 Comparison table -Implants
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ALPHA DENT IMPLANTS Hanauer Straße, 8 75181 Pforzheim
O. ALPHA DEI
IMPLANTS
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Image /page/8/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo consists of the Greek letter alpha followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font. The logo is simple and modern, and it conveys a sense of quality and professionalism.
| Characteristics forcomparison | Subject Device | Subject Device | Primary PredicateDeviceFor IABP and ISPA | ReferenceDeviceFor WETPackaging and16 mm length |
|---|---|---|---|---|
| Alpha DentImplants,Implant ActiveBio Plus (IABP) | Alpha DentImplants,Implant SuperiorActive(ISPA) | Alpha Dent Implants,Implant Active Bio(IAB) | MIS DentalImplant System, | |
| 510(K)Number | - | - | K210499 | K200102 |
| Material | Ti CP 4 of ASTMF67-13 | Ti CP 4 of ASTMF67-13 | Ti Grade 5 of ASTMF136-13(Ti-6Al-4V-ELI) | Titanium Alloy |
| Body design | Tapered,threaded | Tapered, threaded | Tapered, threaded | Tapered,threaded |
| OuterDiameters(mm)(Label) | 3.3; 3.75; 4.2;5.0; 6.0 | 3.5; 4.0; 4.5; 5.0;5.5; 6.0 | 3.3; 3.75; 4.2; 5.0; 6.0 | C1 Implants: 3.30, 3.75,4.20,5.00 mmV3 Implants: 3.30, 3.90,4.30,5.00 mmSEVEN Implants: 3.30,3.75,4.20, 5.00, 6.00 mmLance+ Implants: 3.30,3.75,4.20, 5.00, 6.00 mm |
| Length (mm) | Dia 3.3 - Length8/10/11.5/13Dia 3.75 –Length8/10/11.5/13/16Dia 4.2 - Length8/10/11.5/13/16Dia 5.0 - Length8/10/11.5/13Dia 6.0 - Length8/10/11.5/13 | Dia 3.5 - Length8/10/11.5/13/16Dia 4.0 - Length8/10/11.5/13/16Dia 4.5 - Length8/10/11.5/13/16Dia 5.0 - Length8/10/11.5/13/16Dia 5.5 - Length8/10/11.5/13Dia 6.0 - Length8/10/11.5/13 | Dia 3.3 - Length8/10/11.5/13Dia 3.75 - Length8/10/11.5/13Dia 4.2 - Length8/10/11.5/13Dia 5.0 - Length8/10/11.5/13Dia 6.0 - Length8/10/11.5/13 | 8,10,11.5,13,16,18,20 mm |
| ProstheticConnection | ConicalConnectionwith hexagon | ConicalConnectionwith hexagon | Conical Connectionwith hexagon | Internal hexagonor Conicalconnection |
| Hex Size | 2.10 mm | 2.10 mm | 2.10 mm | NA |
| Platform Dia | 2.80 mm | 2.80 mm | 2.80 mm | NA |
| Abutmentswith angle | 0°; 15°; 17°; 25°;30° | 0°; 15°; 17°; 25°;30° | 0°; 15°; 17°; 25°; 30° | NA |
| Clinicalprocedure | Immediateloading or forloading after a | Immediate loadingor for loading after | Immediate loading orfor loading after a | Immediateloading or forloading after a |
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Image /page/9/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo consists of the Greek letter alpha on the left, followed by the words "ALPHA DENT" in a bold, sans-serif font. Below "ALPHA DENT" is the word "IMPLANTS" in a smaller font. The logo is gray in color.
| conventionalhealing period | a conventionalhealing period | conventional healingperiod | conventionalhealing period | |
|---|---|---|---|---|
| Recommended type ofBone | All Bone types | All Bone types | All Bone types | All Bone types |
| Immediateload | YES | YES | YES | YES |
| Surfacetreatment: | SLA | SLA | SLA | SLA |
| InnerPackageMedium | NaCl solution | NaCl solution | dry | NaCl solution |
| SterilizationMethod | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation |
5.3 SUBSTANTIAL EQUIVALENCE DISCUSSION
a) Based on the information provided in comparison tables, we can make the following scientific summary and conclusions to justify that Alpha Dent Superior Active(ISPA) and Active Bio Plus (IABP) implants are substantially equivalent to MIS Dental Implant System in terms of WETpackaging.
b) Device Classification: Both Alpha Dent Implants (ISPA and IABP) and MIS Dental Implant System are classified as "Implant, Endosseous dental implants." This classification indicates that they serve the same primary purpose in dental implantology.
c) Intended Use: The intended use of both Alpha Dent Implants and MIS Dental Implant System is nearly identical. They are intended to be surgically placed in the maxillary and/or mandibular arches to support prosthetic devices, restore chewing function, and provide support for artificial teeth. Both systems can be used for single tooth or multiple teeth applications and for immediate loading under appropriate conditions.
d) Material: The subject device uses Ti Grade 4 (ASTM F67-13), the primary predicate device uses Titanium Alloy Ti Grade 5 (Ti6Al4V-ELI). AlphaDent has conducted Static and dynamic compression performance test was conducted on worst-case combination of subject Dental Implants and previously cleared dental abutments. Mechanical tests have been performed according to ISO 14801-Dentistry-Implants-Dynamic fatigue test for Endosseous Dental implants.
- . Both implants have comparable dimensions within a similar linear range.
- Each implant features an external double thread with comparable pitch values.
- The smallest implants have core diameters and thread depths that are similar in value.
f)The MIS dental implant System was selected as the reference predicate product because of their same WET packaging in NaCl 0.9%, the close match in implant range, and matching connection types.
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Image /page/10/Picture/0 description: The image shows the text "ALPHA DENT IMPLANTS" in a clear, sans-serif font. Below this, the address "Hanauer Straße, 8" is written, followed by "75181 Pforzheim" on the next line. The text is neatly aligned and presented in a straightforward manner.
.alpha-dent.net
Image /page/10/Picture/2 description: The image shows the logo for Alpha Dent Implants. The logo consists of the greek letter alpha on the left, followed by the words "ALPHA DENT" in a sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font size.
A hydrophilicity test was conducted to evaluate non-aged and 2-year-aged implants. Contact angle measurements were taken using a standardized water drop test with isotonic saline (0.9% NaCl) to ensure a neutral and comparable testing environment. The primary criterion for assessing surface hydrophilicity was the contact angle between the surface and saline solution: a contact angle below 90° signifies a hydrophilic surface, while an angle above 90° indicates a hydrophobic surface. The smaller the angle, the greater the surface wettability. Additionally, the distribution rate of the droplet was qualitatively observed, where rapid spread suggests high hydrophilicity.
Results revealed that the non-aged implant exhibited a contact angle of 34°, indicating a hydrophilic surface, whereas the 2-year-aged implant showed a contact angle of 0°, reflecting complete wetting and maximal hydrophilicity.
g) The SLA surface treatment is characterized by a large grit sand-blasting process, resulting in macroscopic roughness on the titanium surface. The pivotal parameter in SLA surface treatment is the surface roughness value, with optimal results achieved within a narrow range of moderately rough surfaces, typically within Ra values of 1.0 - 2.0 um (Wennerberg & Albrektsson, 2009).
h) Pyrogenicity testing was performed according to USP<85>, ANSI/AAMI ST72 using the LAL method for routine testing of sterile implants.
- h) Biocompatibility:
The subject device, made from Ti Grade 4 (ASTM F67-13), underwent extensive biocompatibility testing per ISO 10993-1:2018 to assess material differences from the Ti Grade 5 predicate device. Tests included cytotoxicity. Packaged in saline-filled polystyrene containers (WET packaging), leaching and toxicology assessments confirmed low levels of extractables, supporting substantial equivalence. Additional cytotoxicity tests on aged implant bodies showed no adverse effects, and SEM/EDX analysis confirmed a clean surface with no harmful contaminants.
i) Inner Package Medium and Sterilization Method: These parameters are similar for both Alpha Dent Implants and MIS Dental Implant System. They both utilize NaCl solution as the inner package medium, are intended for single use, and undergo gamma irradiation for sterilization.
| Predicate deviceAlpha Dent Implants | Subject deviceAlpha Dent Implants | |
|---|---|---|
| Device Name | Healing caps for implants with conical connection | Healing caps for implants with conical connection |
| 510k Number | K210499 | - |
| Connection | Conical hexagon | Conical hexagon |
| Material | Grade 5 (Ti6Al4V-ELI) | Grade 5 (Ti6Al4V-ELI) |
5.3 Comparison table- Prosthetics
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Image /page/11/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo consists of the Greek letter alpha on the left, followed by the words "ALPHA DENT" in a bold, sans-serif font. Below "ALPHA DENT" is the word "IMPLANTS" in a smaller font. The logo is gray in color and is set against a white background.
ALPHA DENT IMPLANTS Hanauer Straße, 8 75181 Pforzheim
| GeneralDesign | Image: top of dental implant | |
|---|---|---|
| Size | HCWK 3:Diameter: 5.5 mmLength: 2/3/4/5 mmPlatform: Narrow Conical Platform 2.1 mmPlatform diameter: 2.80 mm | HCWK 3/7:Diameter: 5.5 mmLength: 7 mmPlatform: Narrow Conical Platform 2.1mmPlatform diameter: 2.80 mmHCWK:Diameter: 6.5/8.0 mmLength: 3/4/5 and 7 mmPlatform: Narrow Conical Platform 2.1mmPlatform diameter: 2.80 mm |
| Principle ofOperation | This product is a healing cap to formationappropriate gingival shape during the softtissue healing period combined withimplant. This product should be removedwhen the superstructure is set up. | This product is a healing cap toformation appropriate gingival shapeduring the soft tissue healing periodcombined with implant. This productshould be removed when thesuperstructure is set up. |
| Similarities | These devices are the same products because they have the same intended use andsimilar design, are made of the equal material, and are used for the same implantssystem with the equal connection. | |
| Differences | Subject devices have additional sizes of diameters and lengths. That is needed forinstallation in molar aria with higher level of tissues and formation of the gingiva shapefor molar teeth.These differences are minor and don't affect the safety of use. | |
| Predicate device | Subject device | |
| Alpha Dent ImplantsAbutment for implants with conical | Alpha Dent ImplantsAbutment for implants with conical | |
| Device Name | connection. | connection. |
| 510k Number | K210499 | |
| Connection | Conical hexagon | Conical hexagon |
| Material | Grade 5 (Ti6Al4V-ELI) | Grade 5 (Ti6Al4V-ELI) |
| GeneralDesign | Image: bottom of dental implant |
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Image /page/12/Picture/0 description: The image shows the address of ALPHA DENT IMPLANTS. The address is Hanauer Straße, 8, 75181 Pforzheim. The text is in a simple, sans-serif font and is easy to read.
Image /page/12/Picture/1 description: The image shows the logo for Alpha Dent Implants. The logo consists of the greek letter alpha on the left, followed by the text "ALPHA DENT" in a larger font. Below the text "ALPHA DENT" is the word "IMPLANTS" in a smaller font.
| TAK 3/0XX – Titanium Abutment Konus Shoulder: | TAK 3/004 – Titanium Abutment Konus Shoulder: | |
|---|---|---|
| Size | Diameter: 4.2 mmLength: 1/2/3 mmPlatform: Narrow Conical Platform 2.1 mmPlatform diameter: 2.80 mm | Diameter: 4.2 mmLength: 4 mmPlatform: Narrow Conical Platform 2.1 mmPlatform diameter: 2.80 mm |
| Principle of Operation | It is indicated for screw retained single tooth or cement retained single tooth and bridge restorations. | It is indicated for screw retained single tooth or cement retained single tooth and bridge restorations. |
| Similarities | These devices are the same products because they have the same intended use and similar design, are made of the equal material and are used for the same implants system with the equal connection. | |
| Differences | Subject devices have additional size of length. That is needed for installation in aria with higher level of tissues. These differences are minor and don't affect the safety of use. | |
| Predicate deviceNobel Biocare | Subject deviceAlpha Dent Implants | |
| Device Name | Healing Cap Multi-Unit Titanium | Healing caps for Multi-Unit System |
| 510k Number | K210499 | |
| Connection | Multi-Unit Abutments | Multi-Unit Abutments |
| Material | Grade 5 (Ti6Al4V-ELI) | Grade 5 (Ti6Al4V-ELI) |
| General Design | Image: Nobel Biocare Healing Cap Multi-Unit Titanium | Image: Alpha Dent Implants Healing caps for Multi-Unit System |
| Sizes | HCAEK:Diameter: 4.7 mmLength: 5.8 mm | HCAEK:Diameter: 4.7 mmLength: 5.8 mmHCAEM:Diameter: 4.3 mmLength: 5 mmHCAEW:Diameter: 6.2 mmLength: 5 mm |
| Principle of Operation | The Healing Cap Multi-unit Titanium is a prosthetic component to be directly connected to the dental Multi-Unit abutment during soft tissue healing to protect the internal connection of the abutments and prepare the soft tissue for the prosthetic procedure. | The Healing Cap Multi-unit Titanium is a prosthetic component to be directly connected to the dental Multi-Unit abutment during soft tissue healing to protect the internal connection of the abutments and prepare the soft tissue for the prosthetic procedure. |
| Similarities | The subject and primary predicate have same indications for use, functions, materials, and general shape (design). | |
| Differences | There are slightly different dimensions in diameter and length.These differences are minor and don't affect the safety of use. |
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Image /page/13/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo consists of the Greek letter alpha on the left, followed by the words "ALPHA DENT" in a bold, sans-serif font. Below the words "ALPHA DENT" is the word "IMPLANTS" in a smaller font. The logo is gray in color.
6. NON-CLINICAL TEST
Mechanical strength testing of the implant system was performed according to FDA "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implants Abutments".
The IABP and ISPA subject devices are manufactured from Grade 4 Titanium (Ti CP4). Mechanical Testing was conducted according to ISO 14801:2016 Dentistry — Implants Dynamic loading test for endosseous dental implants .
Worst Case Scenario: the highest abutment angulation and the lowest diameter implant were tested. The worst case chosen was 25 degrees abutment angulation and 3.3mm diameter.
Static and dynamic compression performance tests were conducted on two types of dental implants: Implant Active Bio Plus (IABP)3.3x13 and Implant Superior Active(ISPA)3.5x13, along with Angulated Titanium Abutment 25 ° angulation.
The results of the testing indicate that the Alpha Dent Implants ISPA and IABP are substantial equivalent to the predicate devices sighted in this submission.
Surface testing
SEM/EDX analysis was conducted to assess cleanliness of the implant surface.
The SLA blasting and acid etching techniques used for surface modification of the dental implants are effective in creating a clean and biocompatible surface. The SEM and EDX analysis validate that no harmful alumina or chemicals remain on the implant surface, with only slight residues of sodium, chlorine, and carbon detected due to the NaCl packaging. The overall surface properties of the modified implants align with established standards in the industry.
Additionally, testing specific to the hydrophilic surface was conducted on aged implants including hydrophilicity (contact angle) measurements.Low contact angle was obtained for as manufactured and 2 years aged implants packed in saline solution (NaCl 0.9%)
Biocompatibility
The IABP and ISPA implants and abutments are categorized as permanent, implant devices with tissue / bone contact according to ISO 10993-1. The implants are made of commercial pure titanium CP4 per ASTM F-67:13. Biocompatibility was conducted according to ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and includes:
- In Vitro Cytotoxicity Study ISO 10993-5:2009
For WET packaging additional leaching and toxicological assessment were conducted. Cytotoxicity after 3 years real time shelf life was conducted
MR Compatibility
Non-clinical worst-case MRI review was performed to evaluate the devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system
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Image /page/14/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo consists of the Greek letter alpha on the left, followed by the words "ALPHA DENT" in a larger, bolder font. Below "ALPHA DENT" is the word "IMPLANTS" in a smaller font. The logo is in a gray color.
DENT IMPI ANTS
ww.alpha-dent.net
including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material compositions. The rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.
Packaging
Package configuration: the implant is placed in a in a titanium protective sleeve within a vial filled with isotonic sodium chloride solution .The vial is then sealed with high density polyethylene (HDPE) cap covered with a lid (1st sterile barrier) and then placed in a polyethylene terephthalate glycol (PETG) blister sealed with Tyvek laminate which provides a durable, and sterile barrier that protects the contents from contamination while maintaining sterility.(2nd sterile barrier). The Implant's Final package is a card box, including a package insert.
Packaging performance testing was conducted according to ISO 11607-1:2019, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
Sterilization validation
Sterilization validation tests were conducted in compliance with ANSI/AAMI/ISO 11137-1 and EN ISO 11137-2 to ensure safety and effectiveness related to Alpha Dent Implants Dental Implants System. Test results have demonstrated that the SAL of 106 was achieved and all testing requirements were met.
Pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile."
Pyrogenicity testing was performed according to USP<85> , ANSI/AAMIST72 using the LAL method for routine testing of sterile implants.
The method used to determine that the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on USP <161>.
Shelf Life
Accelerated aging, conducted in accordance with ASTM-F-1980, has been completed using devices in their final packaging configuration. Package integrity, cytotoxicity tests, and hydrophilicity tests were conducted to support a 2-year shelf-life study is currently underway and will be extended to 5 years, contingent on satisfactory results for package integrity, cytotoxicity tests, and hydrophilicity tests.
Abutments are provided non-sterilized by end users using moist heat sterilization. The sterilization cycle is based on the protocols established for the primary predicate device (K210499).
7. Clinical
No clinical studies were performed
8. Conclusion
Testing data shows that the subject device does not present questions of safety or effectiveness that were not addressed by Alpha Dent Implants. Substantial equivalence to the predicate devices was established based on the existing performance tests provided in this 510(k) Submission. The
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Image /page/15/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo consists of the Greek letter alpha on the left, followed by the words "ALPHA DENT" in a larger font. Below "ALPHA DENT" is the word "IMPLANTS" in a smaller font.
LPHA DENT IMPLANTS
Implant Active Bio (IAB) and Implant cleared under 510(k) number K210499, is intended for the same use, and operate using equivalent clinical procedures as the subject device - Implant Active Bio Plus (IABP) and Implant Superior Active (ISPA) . The reference to the MIS implants, cleared under K200102, was made in order to support the WET packaging in Saline solution, surface treatment, surface morphology and the 16mm lengths.
Based on the analysis of the comparison between the primary predicate, reference device and the subject devices and the performance evaluation results contained in this premarket notification, it was concluded that the proposed device is substantially equivalent to the legally marketed predicate devices (primary and reference devices).
§ 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.