(446 days)
Alpha Dent Implants Dental Implants System is intended for surgical placement in the maxillary and/or mandbular 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.
The Alpha Dent Implants Dental Implants System consists of one or two stage endosseous form dental implants, internal hexagonal and one piece implants system. Abutments are used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation. The implantation procedure can be accomplished in a one-stage surgical operation for all implants type beside the INTEGRAL which is for one stage only. The system includes two-piece implant families: Active, Active Plus, and Classic, and a one-piece implant family: Integral. The system also includes prosthetic components such as healing caps, straight and angular abutments, titanium esthetic abutments, multi-unit abutments, ball attachments, and accessories.
The Alpha Dent Implants Dental Implants System has been assessed for acceptance criteria through a series of non-clinical tests.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Material Biocompatibility | Biocompatibility cytotoxicity testing per ISO 10993-5 was performed and results were successful. The implants and prosthetic components are manufactured from Titanium alloy (Ti 6Al 4V ELI) complying with standard ASTM F 136. |
| Surface Morphology and Cleanliness | SEM and Surface analysis (EDS) after the anodize process demonstrated typical features of an anodized surface structure, and the morphology and cleanliness of the final product. The surface morphology and coating characterization are substantially equivalent to the predicate device K050705. |
| Sterilization Validation | Radiation Sterilization validation tests were conducted in compliance with ANSI/AAMI/ISO 11137-1:06 and EN ISO 11137-2:12. Test results demonstrated that a Sterility Assurance Level (SAL) of 10^-6 was achieved and all testing requirements were met. |
| Pyrogenicity | Pyrogenicity testing was performed according to USP using the LAL method on the sterile implants and met the acceptance criteria as required by USP <85> and <161>. |
| Shelf Life (Packaging Integrity) | Accelerated aging per ASTM-F-1980:07 was applied to the final sterile packaged product. Shelf life studies were completed by an independent testing laboratory in accordance with ISO 11607-1. Test results were successful and supported a 5-year shelf life for the sterilized products. Real-time shelf life studies are completed. |
| Dynamic Fatigue (Mechanical Performance) | Static and dynamic compression performance testing was conducted per ISO 14801:07 - Dentistry - Implants - Dynamic fatigue test for Endosseous Dental implants. The worst-case scenario (highest abutment angulation and lowest diameter implant) was tested. The test articles were able to withstand 5,000,000 cycles without failure at a substantially equivalent load to the cited predicate device. Comparative fatigue testing was conducted against a predicate device of similar intended use, size, and design. The results indicate substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify exact sample sizes for each of the non-clinical tests (biocompatibility, surface analysis, sterilization validation, pyrogenicity, shelf life, and fatigue testing). It generally refers to "test articles" being used. The data provenance is derived from non-clinical laboratory studies conducted by the manufacturer and an independent testing laboratory. The country of origin of the data is not explicitly stated, but the standards cited are international (ISO, ASTM, ANSI/AAMI).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the acceptance criteria and study detailed are based on objective non-clinical performance data and adherence to specified international standards, rather than expert judgment or interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set
This section is not applicable as the acceptance criteria are based on objective measurements and adherence to pre-defined technical standards, not on subjective assessment or adjudication by multiple evaluators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This is a non-clinical evaluation focusing on the physical and mechanical properties of the dental implant system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable as the device is a dental implant system, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was established through:
- International Standards: Adherence to specific requirements outlined in standards like ASTM F 136 (material), ISO 10993-5 (biocompatibility), ANSI/AAMI/ISO 11137-1, EN ISO 11137-2 (sterilization), USP <85>, <161> (pyrogenicity), ASTM-F-1980, ISO 11607-1 (shelf life), and ISO 14801:07 (fatigue testing).
- Predicate Device Equivalence: Performance was compared to legally marketed predicate devices, demonstrating "substantial equivalence" in terms of design, materials, and performance characteristics.
- Objective Measurements: Laboratory measurements such as microscopy for surface morphology (SEM), elemental analysis (EDS), and force/cycle counts for fatigue testing.
8. The Sample Size for the Training Set
This section is not applicable as the device is a dental implant system, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as above.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a solid blue square and the full name written in a smaller font next to it.
July 3, 2019
AlphaDent Implants Ltd % Simha Sibony Regulatory Affairs Consultant Qualitech Top Ltd. P.O. Box 12082 Nahariya, 2201202 Il
Re: K180968
Trade/Device Name: AlphaDent Implants Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 2, 2019 Received: June 5, 2019
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 (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 located 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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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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-regulatoryassistance/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.
Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180968
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 mandbular 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.
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/3/Picture/0 description: The image is a logo for "Alpha Dent Implants". The logo features a stylized red alpha symbol above the words "Alpha Dent" in a bold, sans-serif font. Below "Alpha Dent", the word "IMPLANTS" is written in smaller, spaced-out letters, underlined by a thin red line. The overall design is clean and professional, suggesting a company in the dental or medical field.
510(k) Summary K180968
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
1. GENERAL INFORMATION
| Date Prepared: | 2nd July 2019 |
|---|---|
| Common Name: | Alpha Dent Implants Dental Implants System |
| Classification Name: | Endosseous Dental Implant |
| Class: | II |
| Primary Product Code: | DZE |
| Secondary Product code: | NHA |
| CFR section: | 21 CFR§872.3640 |
| Device panel: | Dental |
| Primary Predicate | K132125-A.B.dental |
| Reference Devices: | K112440-A.B. dental, K061477 Nobel Biocare(Abutments)K050705 - TiUnite® Implants Nobel Biocare(Surface Treatment)K061477-Nobel Biocare Multi-Unit Abutment |
| Submitter: | Dr Boris Simanovski — CEOAlpha Dent Implants Ltd,Carl-Zeiss-Str. 4,Leonberg-Gebersheim71229, GermanyTel: +23834221-715-49E: dr.simanovski@gmail.com |
| Contact: | Simha Sibony- Regulatory Affairs ConsultantQualitech Top LtdE-mail: simha.qualitech@gmail.comTel: +972-52-654-6625 |
2. DEVICE DESCRIPTION
The Alpha Dent Implants Dental Implants System consists of one or two stage endosseous form dental implants, internal hexagonal and one piece implants system
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Image /page/4/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features a stylized red alpha symbol above the words "Alpha Dent" in a bold, black font. Below "Alpha Dent" is the word "IMPLANTS" in smaller, black letters.
Abutments are used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
The implantation procedure can be accomplished in a one-stage surgical operation for all implants type beside the INTEGRAL which is for one stage only.
2. A. Implants sizes and dimensions:
The Alpha Dent internal hex implants system includes two-piece implant families: Active, Active Plus, and Classic. The subject implants system are endosseous dental implants and endosseous dental implant abutments, manufactured from titanium TI-6Al-4V ELI. The implants are 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 chewing function. The root-shaped, screw-type implants are designed for both two-stage and single stage procedures, with one internal thread for screwed abutment. The two-piece implant families have the same internal hex connection and differ in regards to external geometry. Accordingly, the implants are used with the same abutments.
Active Implants
Active implant is a spiral V shaped implant with a triple thread zones. It features an internal Hex well known prosthetic connection,
IA — Implant Active Predicate : 15 - K112440, K132125 Diameter 3.3, 3.75, 4.2, mm Length 8, 10, 11.5,13,16 mm Diameter 5 mm only: Length 8, 10, 11.5,13mm Made of titanium alloy Ti 6Al 4V ELI
Active Plus Implants
Active Plus Implant shares the same triple thread zone concept and spiral V shaped implant as Active implants.
The upper part of the implant with a microthread has an inverse cone shape.
IA+ - Implant Active + Predicate : 110 - K112440 Diameter 4.2; Length 8, 10, 11.5,13, 16 mm Diameter 5 mm; Length 8, 10, 11.5,13 mm Made of titanium alloy Ti 6Al 4V ELI
Classic Implants
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Image /page/5/Picture/0 description: The image is a logo for "Alpha Dent Implants". The logo features a stylized red letter "A" at the top, followed by the words "Alpha Dent" in black. Below the words "Alpha Dent" is a red line, and below the line are the word "IMPLANTS" in smaller black letters.
Predicate: 12-K112440
Diameter 3.75, 4.2, mm Length 8, 10, 11.5,13, 16 mm Diameter 3.3 mm only: Length 10, 11.5,13, 16 mm Diameter 5 mm only: Length 8, 10, 11.5,13, mm Made of titanium alloy Ti 6Al 4V ELI
INTEGRAL Implants
IC — Implant Classic
Integral implant a One-piece implant family is combining implant and abutment. Suitable for immediate loading.
The restoration components are limited for single tooth restoration. Multiple restorations should be splinted together.
IIS – Implant Integral
Diameter 3.3; Length 10, 11.5, 13 ,16 mm
Made of titanium alloy Ti 6Al 4V ELI
2. B. Prosthetic Components
The Alpha Dent Implants Dental Implants System includes prosthetics components that consist of healing caps, Cemented restorations: straight and angular abutments (regular/narrow/ wide/shoulder/esthetic abutment); Screw retained restorations: Multi unit, Titanium Esthetic abutments; Removable restorations: Ball attachments. Accessories: Cover screw, Angular Adaptor, Locator, transfer, Analog and others.
Healing Caps
HC – Healing Cap
HC -Standard :Diameter 4.5 mm; Length 2, 3, 4, 5, 7 mm HCN-Narrow: Diameter 2.4; Length 3,5,7 mm HCW-Wide: Diameter 5.5 mm; Length 2,3,4,5,6 mm Platform 3.75mm Made of titanium alloy Ti 6Al 4V ELI
Straight Abutments- cemented retained restoration
TA – Titanium Abutment TA - Standard: Diameter 4.5 mm; Length 7, 9 , 12 mm TAN - Narrow: Diameter 3.8 mm; Length 7, 9 mm TAW- Wide: Diameter 5.5 mm; Length 9, 12 mm Platform 3.75 mm Made of titanium alloy Ti 6Al 4V ELI
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Image /page/6/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features a stylized red letter 'A' at the top, resembling a calligraphic design. Below the 'A' are the words 'Alpha Dent' in a bold, black font, with the word 'Implants' in smaller, red letters underneath, separated by spaces.
Titanium Abutments (shoulder) - TA00X, TA00XW
TA0XX - Titanium Abutment Shoulder Platform 3.75 mm; X= 01,02,03,07,09,12 mm
TA0XXW- Titanium Abutment Shoulder Wide Platform 3.75 mm; XX= 01, 02, 03, 04 Made of titanium alloy Ti 6Al 4V ELI
Angular Abutments - cemented retained reconstruction
TAA – Titanium Abutment Angulated Angles:15° - TAA015 and 25° - TAA025 Platform : 3.75 mm; Length 9mm TAL – Titanium Abutment Angulated long - 15° Platform : 3.75 mm; Length 11mm Internal Hex Connection Made of titanium alloy Ti 6Al 4V ELI
Titanium Angulated Abutments (shoulder)
TAA0XXYY – Titanium Angulated Abutment with shoulder XX=Angle YY- Shoulder
Angles : 15° and 25° shoulder 01, 02, 03 mm Platform: 3.75 mm; Length 9mm Internal Hex Connection Made of titanium alloy Ti 6Al 4V ELI
Titanium Esthetic Abutments - screw retained restoration
Esthetic Screw Abutment is designed for the screw retained rehabilitation process on single or multiple units.
- In single unit the final abutment post-height should not be less than 4 mm.
TAEX – Titanium Esthetic abutment AEA00X — Anti-rotation Esthetic abutment X-Shoulder Platform: 3.75 mm; shoulder 1, 2, 3 mm Internal Hex Connection
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Image /page/7/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features a stylized red alpha symbol above the words "Alpha Dent" in a bold, black font. Below "Alpha Dent" is the word "IMPLANTS" in smaller, red letters, underlined by a thin red line.
Made of titanium alloy Ti 6Al 4V ELI
Multi-Unit - screw retained reconstruction or removable reconstruction
The Multi-Unit system comprises sizes for both the upper and lower jaws. Multi-Unit, 17° adaptors connects to plastic sleeve.
MUBXXYY – Multi Unit Base XX=Angle 0°,17° YY=Length 1, 2, 3 mm
Platform :3.75 mm Internal Hex Connection
Made of titanium alloy Ti 6Al 4V ELI
Ball attachment - removable restoration
The ball attachment is intended to secure a removable prosthesis.
BA- Ball Attachment
Length; 1, 2, 3, 4, 5, 6 mm Platform :3.75 mm Internal Hex Connection
Made of titanium alloy Ti 6Al 4V ELI
3. Materials:
The implants and prosthetic components are manufactured from Titanium alloy (Ti 6Al 4V ELI) complying with standard ASTM F 136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for surgical implant applications.
Packaging and sterilization:
The Implants are packaged in clean room ISO 7 using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10th validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
Prosthetic Components are supplied Non Sterile.
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Image /page/8/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features a stylized red letter 'alpha' symbol above the words 'Alpha Dent' in a bold, black font. Below 'Alpha Dent' is a red line, and beneath that, the word 'IMPLANTS' is spelled out in smaller, spaced-out black letters.
4. INDICATION FOR USE
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.
5. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES
Alpha Dent Implants Dental Implants System is substantially equivalent to A.B DENTAL DEVICES K132125 in terms of intended use, design, materials used, safety and performance testing. The only difference from primary predicate device K132125 is the surface treatment which is substantial equivalent to K050705 (Nobel Biocare- Ti Unite).
There are minor differences in diameter, threading, body design, apex and neck design that have been mitigated via comparative performance testing per ISO 14801:07 assessed the impact of these differences and demonstrates at least equivalent performance.
The surface analysis results of Alpha Dent Implants shows typical features of anodized surface structure.
The surface morphology and coating characterization are substantial equivalent to predicate device K050705. The complete surface characterization of the Alpha Dent Surface treatment has been detailed in the device description file of this current submission.
Prosthetic components - healing caps and abutments:
Alpha Dent Implants abutments, similarly to its predicate devices, are intended to be placed in implants of different types, diameter, lengths to provide support for prosthetic reconstructions such as crowns and bridges.
Healing caps, Cement retained abutments, screw retained abutments, and ball attachments were compared to equivalent A.B.DENTAL DEVICES (K112440, K132125) internal hex connection abutments, which share the same indications, same material, same angulations, same sizes and did not alter the intended use and new issues of safety and effectiveness were not raised.
The differences in sizes between subject and predicate device for Healing Cap Narrow(HCN) does not impact safety and effectiveness as Healing caps are placed out of occlusion and do not withstand load.
Alpha Dent Multi Unit abutment 17° is similar in design, material, prosthetic and laboratory options and intended use to Multi Unit Nobel Biocare cleared up to 30° (K061477).
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Image /page/9/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features a stylized red alpha symbol above the words "Alpha Dent" in a bold, black font. Below "Alpha Dent" is the word "IMPLANTS" in a smaller, sans-serif font, underlined with a red line.
Therefore, the Alpha Dent Implants Dental Implants System is substantially equivalent to the predicate device and reference devices in terms of intended use, materials used, and technological characteristics
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Image /page/10/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features a stylized red letter "A" above the words "Alpha Dent" in a bold font. Below "Alpha Dent" is the word "IMPLANTS" in a smaller, thinner font with a red line above it.
| Device & PredicateDevice(s): | K180968(Alpha Dent Implants) | K112440(A.B.Dental) Referencedevice | K132125(A.B.Dental)PrimaryPredicate | K061477(NobelBiocare) Referencedevice |
|---|---|---|---|---|
| Implants | ||||
| Characteristics: 3.75platform ,2.4 Internal Hexconnection | (a)Active:Diameter 3.3, 3.75, 4.2 Length8, 10, 11.5,13,16, mmDiameter 5mm only: Length 8,10, 11.5,13mm(b)Active plus: Diameter 4.2;Length 8, 10, 11.5,13, 16 mmDiameter 5 mm; Length 8, 10,11.5,13 mm(c)Classic:Dia 3.3 -L 10,11.5,13,16Dia 3.75, 4.2 -L8, 10,11.5,13, 16Dia 5.0 -L 8, 10,11.5,13(d)Integral :Diameter 3.3; Length 10, 11.5,13,16 mm | (a)I5:AvailableDiameters 3.2,3.75, 4.2, 4.5, 5,6Length 8, 10,11.5, 13, 16(b)I10:AvailableDiameters 4.2,5Length8, 10, 11.5, 13,16(c) I2:AvailableDiameters3.25, 3.75, 4.2,4.5, 5, 6Length8, 10, 11.5, 13,16, 18, 20(d) I7 Integral :Diameter 3.2,3.75, 4.2, 5 , 6Length L10,11.5, 13, 16 | (a)I5:AvailableDiameters 3.5Length 8, 10,11.5, 13, 16(c) I2:AvailableDiameters3.5Length8, 10, 11.5, 13,16 | |
| Indication for Use | [2] below this table | [3] below thistable | [1] below thistable | [4] below this table |
| Product Code | DZE | DZE | DZE | NHA |
| Material | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Surface Treatment | Anodized layer | SLA(SandBlasting andAcid etched) | RBM(Resorbable BlastingMedia) | NA |
| Implant/abutment | Internal HEX Connection 2.4mm | Internal HEX | Internal HEX | Internal HEX |
| connection | Connection | Connection | Connection 2.4 mm | |
| 2.4mm | 2.4 mm | |||
| Sterilisation | Gamma Radiation | GammaRadiation | GammaRadiation | NA |
| Abutments | ||||
| Sterility | Non Sterile | Non Sterile | Non Sterile | Non Sterile |
| Product code | NHA | NHA | NHA | NHA |
| Characteristics: 3.75mm platform2.4 Internal Hexconnection | HC - Healing Caps3.75mm platform:HC-Standard has diameter of 4.5mm and length of 2,3,4,5 and 7mm.HCN-Narrow has diameter of 2.4mm and length of 3,5 and 7 mmHCW-Wide has diameter of 5.5mm and length of 2,3,4,5,6 mm | P0-Healing CapDiameter:3.75mmLength: 2, 3, 4,5, 6, 7mm | ||
| Characteristics: 3.75mm platform2.4 Internal Hexconnectionmade of Ti 6Al 4VELI | TA-Straight anti rotationabutmentTA-Standard: Diameter 4.5 mm;Length 7, 9 , 12 mmTAN-Narrow: Diameter 3.8 mm;Length 7, 9 mmTAW-Wide: Diameter 5.5 mm;Length 9, 12 mm | P3 - abutmentanti rotationP3-Standard:Diameter 3.75,5mmL5, 7, 9, 12,15mmP3W-Wide:Diameter 3.75;L9,12mm | ||
| Characteristics: 3.75mm platform2.4 Internal Hexconnectionmade of Ti 6Al 4VELI | TA0XX – Titanium AbutmentShoulderShoulder: 1,2,3,7,9,12 mmPlatform 3.75 mm;TA0XXW- Titanium AbutmentShoulder WideShoulder: 1, 2, 3, 4Platform 3.75 mm; | P3S-Anti-rotationabutment withshoulderShoulder:1,2,3Platform 3.75mm; | ||
| Characteristics: 3.75mm platform2.4 Internal Hexconnectionmade of Ti 6Al 4VELI | TAA-Angular Abutments:15° and 25°/3.75 mm(diam) | P4-Angularabutment 15°and 25°/3.75mm(diam) | ||
| Characteristics: 3.75 | TAA0XXYY - Titanium Angulated | P4S-Angular |
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Image /page/11/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features a stylized red letter "A" above the words "Alpha Dent" in a bold font. Below "Alpha Dent" is the word "IMPLANTS" in smaller, spaced-out letters, underlined with a thin red line.
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Image /page/12/Picture/0 description: The image is a logo for "Alpha Dent Implants". The logo features a stylized red letter "A" above the words "Alpha Dent" in a bold, black font. Below "Alpha Dent" is the word "IMPLANTS" in a smaller, red font with wide spacing between the letters.
| mm platform2.4 Internal Hexconnectionmade of Ti 6Al 4VELI | Abutment-shoulder15°, 25°3.75 (diam) | abutment withshoulder15°, 25 °3.75 (diam) |
|---|---|---|
| Characteristics: 3.75mm platform2.4 Internal Hexconnection | TAE &AEA - Titanium EstheticAbutments &EstheticAntirotational(shoulder)3.75 mm platform | P7- Anti-rotationAestheticP6H- StraightAdaptorAbutment3.75 mm |
| made of Ti 6Al 4VELI | 3.75 mm diameter and shoulderheight of either 1,2 or 3 mm.Final post height of the abutmentshould not be less than 4 mm | diameter andshoulder heightof either 1,2 or 3mm. |
| Characteristics: 3.75mm platform2.4 Internal Hexconnectionmade of Ti 6Al 4VELI, | BA- Ball attachment:Characteristics: 3.75 mmplatformdevice length is 1 to 6 mm, noangle | P5- Ballattachmentabutment.Characteristics: 3.75 mmplatformdevice lengthis 1 to 6 mm,no angle |
| Characteristics: 3.75mm platform2.4 Internal Hexconnection | MUB-Multi-Unit Base 17°- screwretained reconstructionCharacteristics: 3.75 mmplatform | Multi- Unit3.5,3.9 (diam)/ length2, 2.5, 3, 3.5, 4, 4.5, 5mmup to 30° |
| made of Ti 6Al 4VELI, | 4.7 (diam)/1,2,3 mm length, 17° |
[1] The A.B. Dental Devices Dental Implants 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 patients chewing function. A.B. Dental Devices Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
[2] 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.
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Image /page/13/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features a stylized red letter "A" above the words "Alpha Dent" in black font. Below the words "Alpha Dent" is the word "IMPLANTS" in smaller, red font.
The Alpha Dent Implants Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
[3] The A.B. Dental Devices implants are intended for surgical' placement in the maxillary mandibular and/or arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
17 Integral implant, 15 Conical implant, P15 Temporary abutment, P12-T,L Temporary flat connection abutment, and P16 Straight adaptor are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
[4] Nobel Biocare's Multi-Unit Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. Nobel Biocare's Multi-Unit Abutments fit the following endosseous implants:
- AstraTech 3.5, 4.0, 4.5, 5.0 mm
- Camlog 3.3, 3.8, 4.3, 5.0, 6.0 mm
- Ankylos 3.5, 4.5, 5.5, 7.0 mm
6. NON-CLINICAL TEST
The components are manufactured from medical grade Titanium alloy (Ti 6Al 4V ELI) per ASTM F 136.
Biocompatibility - The subject device is manufactured using similar manufacturing methods using the same raw material as the cited predicate. The subject device has the
same intended use, patient contact duration and type as the predicate.
Biocompatibility cytotoxicity testing according ISO 10993-5 was performed and results were successful.
SEM and Surface analysis (EDS) after Anodize process demonstrated the morphology and cleanliness of the final product.
Radiation Sterilization validation tests were conducted in compliance with ANSI/AAMI/ISO 11137-1:06 and EN ISO 11137-2:12 in order to demonstrate substantial equivalence related to Alpha Dent Implants Dental Implants System to previously cleared devices. Test results have demonstrated that the SAL of 10th was achieved and all testing requirements were met.
Pyrogenicity testing was performed according USP using the LAL method testing on the sterile implants and met the acceptance criteria as required by USP <85> and <161>.
Accelerated aging per ASTM-F-1980:07 have been applied on the final sterile packaged product.
Shelf life studies were completed by an independent testing laboratory in order to validate the integrity of the final package. The studies were conducted in accordance with ISO 11607-1. Test results were successful and supported a 5 year shelf life of the sterilized products. Real Time shelf life is completed.
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Image /page/14/Picture/0 description: The image shows the logo for Alpha Dent Implants. The logo features a stylized red letter "A" above the words "Alpha Dent" in black font. Below the words "Alpha Dent" is the word "IMPLANTS" in smaller, red font.
Comparative fatigue testing was done on a predicate device of similar intended use, size and design.
Static and dynamic compression performance test was conducted per ISO 14801: 07-Dentistry-Implants-Dynamic fatigue test for Endosseous Dental implants.
The worst case scenario was chosen based on the FDA guideline "Class II Special Controls Guidance Document: Root form for Endosseous dental implants and Endosseous dental Implant Abutments": the highest abutment angulation and the lowest diameter implant. The worst case implants and abutments chosen for the tests were the narrowest implants loaded with the abutments which have the greatest angulation. The test articles were able to withstand 5,000,000 cycles without failure at a substantially equivalent load to the cited predicate
The results of the testing indicate that the Alpha Dent Implants Dental Implants System is substantial equivalent to the predicate device sighted in this submission.
7. CLINICAL TEST
No clinical studies were performed.
8. CONCLUSION
The results of the testing conducted on the Alpha Dent Implants Dental Implants System demonstrated that the system is substantially equivalent to the named predicated device in terms of functional, mechanical properties, indications for use and material. The Alpha Dent Implants Dental Implants System has the same intended use, incorporate the same fundamental technology, and has similar indications for use as the predicate and reference devices. Test data to verify the performance of the Alpha Dent Implants Dental Implants has been provided including: dynamic fatigue, sterilization validation, shelf life, biocompatibility and the results of the testing, combined with the design and intended use comparison with the predicate device, support substantial equivalence.
§ 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.