AlphaDent Implants Dental Implants System

K180968 · Alphadent Implants, Ltd. · DZE · Jul 3, 2019 · Dental

Device Facts

Record IDK180968
Device NameAlphaDent Implants Dental Implants System
ApplicantAlphadent Implants, Ltd.
Product CodeDZE · Dental
Decision DateJul 3, 2019
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3640
Device ClassClass 2
AttributesTherapeutic

Intended 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.

Device Story

The Alpha Dent Implants Dental Implants System consists of root-shaped, screw-type endosseous dental implants and associated prosthetic components (abutments, healing caps, ball attachments). Implants are surgically placed in the maxillary or mandibular bone by a dental professional to support prosthetic restorations (crowns, bridges, overdentures). The system features an internal hexagonal connection. The device transforms mechanical input (surgical placement into bone) into a stable foundation for prosthetic rehabilitation. The system supports both one-stage and two-stage surgical procedures. The INTEGRAL implant family is a one-piece design suitable for immediate loading. Prosthetic components are either screw-retained or cement-retained. The device restores chewing function and provides aesthetic support for artificial teeth. Clinical benefit includes restoration of oral function in edentulous patients.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993-5), dynamic fatigue testing (ISO 14801:07) demonstrating survival of 5,000,000 cycles, sterilization validation (ANSI/AAMI/ISO 11137-1), and shelf-life validation (ISO 11607-1).

Technological Characteristics

Materials: Titanium alloy Ti-6Al-4V ELI (ASTM F 136). Design: Root-shaped, screw-type endosseous implants with internal hex connection. Surface: Anodized. Sterilization: Gamma radiation (SAL 10^-6). Connectivity: Mechanical interface for prosthetic components. Form factor: Various diameters (3.3mm–5mm) and lengths (8mm–16mm).

Indications for Use

Indicated for edentulous patients requiring surgical placement of endosseous dental implants in the maxillary or mandibular arch to support crowns, bridges, or overdentures and restore chewing function. Suitable for single or multiple tooth applications. Indicated for immediate loading when primary stability and appropriate occlusal loading are achieved.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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 {2}------------------------------------------------ # 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) | <div> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </div> | |---------------------------------------------------------------------------| | <div> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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)<br>K050705 - TiUnite® Implants Nobel Biocare(Surface Treatment)<br>K061477-Nobel Biocare Multi-Unit Abutment | | Submitter: | Dr Boris Simanovski — CEO<br>Alpha Dent Implants Ltd,<br>Carl-Zeiss-Str. 4,<br>Leonberg-Gebersheim71229, Germany<br>Tel: +23834221-715-49<br>E: dr.simanovski@gmail.com | | Contact: | Simha Sibony- Regulatory Affairs Consultant<br>Qualitech Top Ltd<br>E-mail: simha.qualitech@gmail.com<br>Tel: +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 {4}------------------------------------------------ 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 {5}------------------------------------------------ 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 {6}------------------------------------------------ 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 {7}------------------------------------------------ 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. {8}------------------------------------------------ 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). {9}------------------------------------------------ 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 {10}------------------------------------------------ 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 & Predicate<br>Device(s): | K180968(Alpha Dent Implants) | K112440(A.B.Dental) Reference<br>device | K132125(A.B.<br>Dental)<br>Primary<br>Predicate | K061477(Nobel<br>Biocare) Reference<br>device | |----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------| | Implants | | | | | | Characteristics: 3.75<br>platform ,<br>2.4 Internal Hex<br>connection | (a)Active:<br>Diameter 3.3, 3.75, 4.2 Length<br>8, 10, 11.5,13,16, mm<br>Diameter 5mm only: Length 8,<br>10, 11.5,13mm<br>(b)Active plus: Diameter 4.2;<br>Length 8, 10, 11.5,13, 16 mm<br>Diameter 5 mm; Length 8, 10,<br>11.5,13 mm<br>(c)Classic:<br>Dia 3.3 -L 10,11.5,13,16<br>Dia 3.75, 4.2 -L8, 10,11.5,13, 16<br>Dia 5.0 -L 8, 10,11.5,13<br>(d)Integral :<br>Diameter 3.3; Length 10, 11.5,<br>13,16 mm | (a)I5:<br>Available<br>Diameters 3.2,<br>3.75, 4.2, 4.5, 5,<br>6<br>Length 8, 10,<br>11.5, 13, 16<br>(b)I10:<br>Available<br>Diameters 4.2,<br>5<br>Length<br>8, 10, 11.5, 13,<br>16<br>(c) I2:<br>Available<br>Diameters<br>3.25, 3.75, 4.2,<br>4.5, 5, 6<br>Length<br>8, 10, 11.5, 13,<br>16, 18, 20<br>(d) I7 Integral :<br>Diameter 3.2,<br>3.75, 4.2, 5 , 6<br>Length L10,<br>11.5, 13, 16 | (a)I5:<br>Available<br>Diameters 3.5<br>Length 8, 10,<br>11.5, 13, 16<br>(c) I2:<br>Available<br>Diameters<br>3.5<br>Length<br>8, 10, 11.5, 13,<br>16 | | | Indication for Use | [2] below this table | [3] below this<br>table | [1] below this<br>table | [4] below this table | | Product Code | DZE | DZE | DZE | NHA | | Material | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy | | Surface Treatment | Anodized layer | SLA(Sand<br>Blasting and<br>Acid etched) | RBM(Resorbable Blasting<br>Media) | 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 | Gamma<br>Radiation | Gamma<br>Radiation | NA | | Abutments | | | | | | Sterility | Non Sterile | Non Sterile | Non Sterile | Non Sterile | | Product code | NHA | NHA | NHA | NHA | | Characteristics: 3.75<br>mm platform<br>2.4 Internal Hex<br>connection | HC - Healing Caps<br>3.75mm platform:<br>HC-Standard has diameter of 4.5<br>mm and length of 2,3,4,5 and 7<br>mm.<br>HCN-Narrow has diameter of 2.4<br>mm and length of 3,5 and 7 mm<br>HCW-Wide has diameter of 5.5<br>mm and length of 2,3,4,5,6 mm | P0-Healing Cap<br>Diameter:<br>3.75mm<br>Length: 2, 3, 4,<br>5, 6, 7mm | | | | Characteristics: 3.75<br>mm platform<br>2.4 Internal Hex<br>connection<br>made of Ti 6Al 4V<br>ELI | TA-Straight anti rotation<br>abutment<br>TA-Standard: Diameter 4.5 mm;<br>Length 7, 9 , 12 mm<br>TAN-Narrow: Diameter 3.8 mm;<br>Length 7, 9 mm<br>TAW-Wide: Diameter 5.5 mm;<br>Length 9, 12 mm | P3 - abutment<br>anti rotation<br>P3-Standard:<br>Diameter 3.75,<br>5mm<br>L5, 7, 9, 12,<br>15mm<br>P3W-Wide:<br>Diameter 3.75;<br>L9,12mm | | | | Characteristics: 3.75<br>mm platform<br>2.4 Internal Hex<br>connection<br>made of Ti 6Al 4V<br>ELI | TA0XX – Titanium Abutment<br>Shoulder<br>Shoulder: 1,2,3,7,9,12 mm<br>Platform 3.75 mm;<br>TA0XXW- Titanium Abutment<br>Shoulder Wide<br>Shoulder: 1, 2, 3, 4<br>Platform 3.75 mm; | P3S-Anti-<br>rotation<br>abutment with<br>shoulder<br>Shoulder:<br>1,2,3<br>Platform 3.75<br>mm; | | | | Characteristics: 3.75<br>mm platform<br>2.4 Internal Hex<br>connection<br>made of Ti 6Al 4V<br>ELI | TAA-Angular Abutments:<br>15° and 25°/3.75 mm(diam) | | P4-Angular<br>abutment 15°<br>and 25°<br>/3.75mm<br>(diam) | | | Characteristics: 3.75 | TAA0XXYY - Titanium Angulated | | P4S-Angular | | {11}------------------------------------------------ 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. {12}------------------------------------------------ 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 platform<br>2.4 Internal Hex<br>connection<br>made of Ti 6Al 4V<br>ELI | Abutment-shoulder<br>15°, 25°<br>3.75 (diam) | abutment with<br>shoulder<br>15°, 25 °<br>3.75 (diam) | |-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | Characteristics: 3.75<br>mm platform<br>2.4 Internal Hex<br>connection | TAE &AEA - Titanium Esthetic<br>Abutments &Esthetic<br>Antirotational(shoulder)<br>3.75 mm platform | P7- Anti-rotation<br>Aesthetic<br>P6H- Straight<br>Adaptor<br>Abutment<br>3.75 mm | | made of Ti 6Al 4V<br>ELI | 3.75 mm diameter and shoulder<br>height of either 1,2 or 3 mm.<br>Final post height of the abutment<br>should not be less than 4 mm | diameter and<br>shoulder height<br>of either 1,2 or 3<br>mm. | | Characteristics: 3.75<br>mm platform<br>2.4 Internal Hex<br>connection<br>made of Ti 6Al 4V<br>ELI, | BA- Ball attachment:<br>Characteristics: 3.75 mm<br>platform<br>device length is 1 to 6 mm, no<br>angle | P5- Ball<br>attachment<br>abutment.<br>Characteristics<br>: 3.75 mm<br>platform<br>device length<br>is 1 to 6 mm,<br>no angle | | Characteristics: 3.75<br>mm platform<br>2.4 Internal Hex<br>connection | MUB-Multi-Unit Base 17°- screw<br>retained reconstruction<br>Characteristics: 3.75 mm<br>platform | Multi- Unit<br>3.5,3.9 (diam)/ length<br>2, 2.5, 3, 3.5, 4, 4.5, 5<br>mm<br>up to 30° | | made of Ti 6Al 4V<br>ELI, | 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. {13}------------------------------------------------ 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. {14}------------------------------------------------ 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.
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