ABC Dental Implant System

K202092 · Abracadabra Implants , Ltd. · DZE · Sep 23, 2021 · Dental

Device Facts

• Record ID: K202092
• Device Name: ABC Dental Implant System
• Applicant: Abracadabra Implants , Ltd.
• Product Code: DZE · Dental
• Decision Date: Sep 23, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ABC Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The ABC Dental Implant System is also indicated for immediate loading when good primary stability of the implants is achieved, and with appropriate occlusal loading.

Device Story

Internal hex dental implant system; includes tapered cylindrical implants, abutments (straight, angled, multi-unit, overdenture, ball attachments), and healing caps. Implants feature grit-blasted, acid-etched surface. Used by dentists in surgical/restorative procedures to support prosthetic teeth. Implants placed in upper/lower jaw bone; provide support for artificial teeth to restore chewing function. Immediate loading indicated if primary stability achieved. Abutments screw-retained; some removable by patient (ball attachments/flat abutments), others by dentist. Benefits include restoration of chewing function and prosthetic support.

Clinical Evidence

Bench testing only. Includes ISO 14801 dynamic fatigue testing demonstrating run-out limits comparable or superior to predicate systems. Biocompatibility testing per ISO 10993-5 confirmed no cytotoxic potential. Endotoxin testing performed per USP 161. Package integrity and accelerated aging testing conducted.

Technological Characteristics

Material: ASTM F136 Ti-6Al-4V ELI (Grade 5) titanium alloy. Design: Internal hex, tapered cylindrical implant with grit-blasted and acid-etched surface. Dimensions: Diameters 3.3-6.0mm; lengths 8-16mm. Connectivity: Internal hex abutment interface. Sterilization: Gamma radiation for implants; steam sterilization for abutments.

Indications for Use

Indicated for edentulous and partially dentate patients requiring surgical and restorative dental implants in the upper or lower jaw to support prosthetic devices and restore chewing function; includes immediate loading when primary stability is 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

• Alpha-Bio Tec® Dental Implant System (SPI DFI NEO) (K063364)

Reference Devices

• ARDS Dental Implants (Classic and Premium CIC) (K071803)

Submission Summary (Full Text)

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September 23, 2021

Abracadabra Implants Ltd Vladislav Dvoyris VP Marketing and Clinical Education 12 Hacharoshet St. Or-Yehuda 6037580 ISRAEL

Re: K202092

Trade/Device Name: ABC Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 23, 2021 Received: August 27, 2021

Dear Vladislav Dvoyris:

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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Andrew 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

510(k) Number (if known) K202092

Device Name ABC Dental Implant System

#### Indications for Use (Describe)

The ABC Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The ABC Dental Implant System is also indicated for immediate loading when good primary stability of the implants 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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## 510k Summary, September 18, 2021 ABC Dental Implant System - K202092

Name and address: Abracadabra Implants Ltd 12 Hacharoshet St Or Yehuda, Israel, 6037580 Contact Person: Daniel Younisian Phone Number: [phone] Name of device: ABC Dental Implant System Classification Name: Endosseous dental implant CFR: 21 CFR 872.3640 Primary Product Code: DZE Secondary Product Code: NHA

Trade name information: The ABC Dental Implant System is intended to be marketed under the trade name "ABraCadabra Implants".

Primary Predicate Device: Alpha-Bio Tec® Dental Implant System (SPI DFI NEO) -K063364 Reference Devices: ARDS Dental Implants (Classic and Premium CIC) - K071803

Device Description: ABC Dental Implant System is an internal hex implant system with one model of implant at this time. ABC dental implant is a slightly tapered cylindrical internal hex implant with micro-rings at the implant neck, which comes in 3.3. 3.75, 4.2, 5.0, and 6.0 diameter. The implants come in lengths of 8, 10, 11.5, 13, and 16. The 5.0 and 6.0 diameter implants do not come in a length of 16mm.

All implants and abutments are made of ASTM F136 Ti 6A1 4V ELI. The implants have a grit blasted and acid etched surface. All types of abutments can be used with all implants.

Straight abutments, standard narrow abutments, anatomic angled abutments, straight shoulder abutments, and straight wide shoulder abutments are all screw-retained permanent abutments for single or multiple restorations. Straight abutments come in 5. 7, 9, or 11mm leneths and shouldered straight abutments come 1, 2, 3, or 4mm in height. Wide straight shoulder abutments come in heights of 1, 2, or 3mm. Standard narrow abutments come in lengths of 5, 7, 9, 11 mm. Smooth straight wide abutments come in lengths of 5, 7, 9, and 11 mm and the grooved version comes only in 9mm. 15° anatomic angulated abutments come in heights of 1, 2, or 3 mm. 25° anatomic angled abutments come in heights of 1, 2, or 3mm.

Straight multi-unit abutments, overdenture abutments, and ball attachments are permanent threaded abutments which are for multi-restorations only. Ball attachments come in gingival heights of 0.5, 1, 2, 3, 4, 5, or 6mm. Overdenture abutments come in heights of 0.5, 1.5, or 2.5 mm. Straight multi-units come in gingival heights of 1, 2, 3 or 4 mm. Straight multi-unit mounted dentures can only be removed by the dentist, but dentures mounted on flat abutments or ball attachments can be removed by the patient.

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Healing caps (3.8, 4.5, 5.5, and 6.0 mm diameter) are temporary use abutments used during the healing phase which come in different gingival heights in order to account for tissue thickness differences. The 3.8mm diameter healing caps come in heights of 3, 4, 5, 6 and 7 mm. The 4.5 and 5.5 mm diameter healing caps come in heights of 2, 3, 4, 5, 6 and 7mm. The 6.3 mm diameter healing cap comes in heights of 2, 3, 4, and 5 mm.

## Indications for Use:

The ABC Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The ABC Dental Implant System is also indicated for immediate loading when good primary stability of the implants is achieved, and with appropriate occlusal loading.

# Substantial Equivalence:

ABC Dental Implant System is substantially equivalent to Alpha-Bio Tec Dental Implant System in indications for use, materials, design, and fatigue performance.

| Characteristic | ABC Dental Implants<br>(Bolero) | Alpha-Bio Tec® Dental<br>Implant System (SPI DFI<br>NEO) | ARDS Dental Implants<br>(Classic and Premium CIC) | |
|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use/Indication | The ABC Dental Implants<br>System is indicated for use in<br>surgical and restorative<br>applications for placement in<br>the bone of the upper or lower<br>jaw to provide support for<br>prosthetic devices, such as<br>artificial teeth, to restore the<br>patient's chewing function.<br>The ABC Dental Implants<br>System is also indicated for<br>immediate loading when good<br>primary stability is achieved<br>and with appropriate occlusal<br>loading | The Alpha-Bio Dental Implant<br>System® is<br>indicated for use in surgical<br>and restorative applications<br>for<br>placement in the bone of the<br>upper or lower jaw to provide<br>support<br>for prosthetic devices, such as<br>artificial teeth, to restore<br>the patient's chewing function.<br>The Alpha-Bio Dental Implant<br>System® is indicated also for<br>immediate loading when good<br>primary stability is achieved<br>and with appropriate occlusal<br>loading. | ARDS dental implants are<br>indicated for use in surgical<br>and restorative<br>applications for placement in<br>the bone of the upper and<br>lower jaw to provide<br>support for prosthetic devices<br>to restore the patient's<br>chewing function. ARDS<br>dental implants are indicated<br>for two-stage surgery. | |
| Site/Bone type | Bolero is suitable for dense<br>bone D1 / D2 and soft bone<br>D3 / D4 in the upper or lower<br>jaw. | SPI does not state a specific<br>site or bone site indication.<br>DFI is referred by the<br>manufacturer as Suitable for<br>all bone types, ideal for use in<br>bone types D2 and D3.<br>NEO is referred by the<br>manufacturer as Suitable for<br>all bone types D2, D3 and D4. | Classic will optimally be used<br>for softer bone when bone<br>compression around the<br>implant can be done<br>Premium recommended to be<br>used also for harder and more<br>condensed bones such as type<br>D1<br>CIC is referred by the<br>manufacturer as Suitable for<br>all bone types, ideal for use in<br>bone types D2 D3 and D4. | |
| Population | Edentulous and partially<br>dentate patients | Edentulous and partially<br>dentate patients | Edentulous and partially<br>dentate patients | |
| Performance | Intended to provide support<br>for prosthetic devices, such as<br>artificial teeth, in order to | Intended to provide support<br>for prosthetic devices, such as<br>artificial teeth, in order to | Intended to provide support<br>for prosthetic devices, such as<br>artificial teeth, in order to | |
| Characteristic | ABC Dental Implants<br>(Bolero) | Alpha-Bio Tec® Dental<br>Implant System (SPI DFI<br>NEO) | ARDS Dental Implants<br>(Classic and Premium CIC) | |
| | restore the patients' chewing<br>function. | restore the patients' chewing<br>function. | restore the patients' chewing<br>function. | |
| Device Design | Screw-shaped Titanium dental<br>implant -<br>Bolero parallel | Screw-shaped Titanium dental<br>implant<br>SPI Conical<br>DFI parallel<br>NEO Conical | Screw-shaped Titanium dental<br>implant<br>Classic - Conical<br>Premium - Parallel<br>CIC- Conical | |
| Placement Method | One and two-stage procedure. | One and two-stage procedure. | Two-stage procedure. | |
| Material | Ti-6Al-4V Eli ASTM F136<br>(Grade 5) | Ti-6Al-4V Eli (Grade 5) | Ti-6Al-4V Eli (Grade 5) | |
| Dimensions and<br>tolerances Diameter<br>(mm) | Bolero - 3.3, 3.75, 4.2, 5mm<br>±0.1mm | SPI-3.3, 3.75, 4.2, 5, 6mm<br>±0.1mm<br>DFI- 3.3, 3.75, 4.2, 5mm<br>±0.1mm<br>NEO- 3.75, 4.2, 5.0mm<br>±0.1mm | Classic - 3.3, 3.75, 4.2, 5,<br>6mm ±0.1mm<br>Premium -3.3, 3.75, 4.2, 5,<br>6mm ±0.1mm<br>CIC- 3.5mm ±0.1mm | |
| Dimensions and<br>tolerances length<br>(mm) | 6, 8, 10, 11.5, 13,<br>16mm±0.1mm | 6, 8, 10, 11.5, 13,<br>16mm±0.1mm | 8, 10, 11.5, 13, 16mm ±0.1mm | |
| Anti-rotational<br>features-internal<br>external hexagonal.<br>etc. | internal hexagonal | internal hexagonal | internal hexagonal | |
| Device features | Self-tapping and self-<br>condensing tapered titanium<br>screw implant | Self-tapping and self-<br>condensing tapered titanium<br>screw implant with variable<br>thread design | Self-tapping titanium screw<br>implant with dual thread<br>design | |
| Flat axial surface<br>features on the<br>implant | None | None | None | |
| Internal hex.<br>threads(inch) | 1#72 | 1#72 | 1#72 | |
| Abutment<br>connection | Hexagon + screw | Screw or hexagon + screw | Screw or hexagon + screw | |
| Surface treatment | Sandblasting, followed by<br>cleaning by acid treatment | Sandblasting, followed by<br>cleaning by acid treatment | Sandblasting, followed by<br>cleaning by acid treatment | |
| Packaging | Double vial | Vial and a Blister | Double vial | |
| Implant Sterilization | Gamma Radiation | Gamma Radiation | Gamma Radiation | |
| Components | The ABC Dental Implant<br>System consists of one and<br>two-stage endosseous form<br>dental implants with an<br>internal hexagonal<br>connection; cover screw and<br>healing caps; abutment<br>systems and superstructures;<br>surgical instruments (*). | The Alpha-Bio Dental Implant<br>System® consists of one and<br>two-stage endosseous form<br>dental implants, with an<br>internal hexagonal connection;<br>cover screws and healing caps;<br>abutment systems and<br>Superstructures; surgical<br>instruments (*). | The Alpha-Bio Dental Implant<br>System® consists of one and<br>two-stage endosseous form<br>dental implants, with an<br>internal hexagonal connection;<br>cover screws and healing caps;<br>abutment systems and<br>Superstructures; surgical<br>instruments (*). | |
| Abutments<br>[refer to abutment<br>comparison in the<br>rows below] | Straight & up to 25° | Straight & up to 25° | Straight & up to 25° | |
| Abutment Type/Dimensions | | ABC | Alpha Bio | ARDS Dental Implants |
| | Standard<br>abutment | screw thread - 1#72 inch.<br>Diameter: 3.8, 4.5, 5.5 | screw thread - 1#72 inch.<br>Diameter: 3.5, 4.5, 5.5 mm | screw thread - 1#72 inch.<br>Diameter: Slim - 3.8mm<br>Normal - 4.5mm,<br>Wide - 5.5,6.3mm |
| | Standard<br>abutment<br>with<br>shoulder | screw thread - 1#72 inch.<br>Diameter:3.8, 4.5, 5.5mm.<br>Shoulder height: 1, 2, 3,<br>4mm. | screw thread - 1#72 inch.<br>Diameter: 4.5, 5.5mm<br>Shoulder height: 1,<br>2,3,4mm. | screw thread - 1#72 inch.<br>Diameter: normal -<br>4.5mm, wide - 5.5mm.<br>Shoulder height 1-4mm |
| | 15° Angular<br>abutment | screw thread - 1#72 inch.<br>Diameter: 4.5, mm. | screw thread - 1#72 inch.<br>Diameter: 4.5, mm. | screw thread - 1#72 inch.<br>diameter- normal-<br>4.5mm, wide- 5.5 mm |
| | 25° Angular<br>abutment | screw thread - 1#72 inch.<br>Diameter: 4.5, mm. | screw thread - 1#72 inch.<br>Diameter: 4.7mm. | screw thread - 1#72 inch.<br>diameter- 4.7mm |
| | 15° Angular<br>abutment<br>with<br>shoulder | screw thread - 1#72 inch.<br>Diameter: 4.5, mm.<br>Shoulder height 1,2,3,4mm. | screw thread - 1#72 inch.<br>Diameter: 4.7mm.<br>Shoulder height 1,2,3mm. | screw thread - 1#72 inch.<br>Diameter -4.5 mm.<br>Shoulder height 1-2mm |
| | 25° Angular<br>abutment<br>with<br>shoulder | Connection: Internal<br>hexagon - 2.43 mm<br>diameter,<br>screw thread - 1#72 inch.<br>Diameter:4.5, mm.<br>Shoulder height 1,2,3,4mm. | Connection: Internal<br>hexagon - 2.43 mm<br>diameter.<br>screw thread - 1#72 inch.<br>Diameter: 4.7mm.<br>Shoulder height 1,2,3mm. | Connection: Internal<br>hexagon - 2.43 mm<br>diameter,<br>screw thread - 1#72 inch.<br>Diameter - 4.7 mm.<br>Shoulder height 1-2mm |
| | Standard<br>Healing<br>Cap | 4.6 mm in diameter<br>L: 2-8mm | 4.6 mm in diameter<br>L: 2-7mm | 4.5 mm in diameter<br>L: 3-5mm |
| | Standard<br>Healing<br>Cap Narrow | 3.8 mm in diameter<br>L: 2-7mm | 3.85 mm in diameter<br>L: 3-5mm | 3.8 mm in diameter<br>L: 3-5mm |
| | Standard<br>Healing<br>Cap Wide | 5.5 mm in diameter<br>L: 2-7mm | 5.5 mm in diameter<br>L: 3-5mm | 4.7 mm in diameter<br>L: 3-5mm |
| | Standard<br>Healing<br>Cap Extra<br>Wide | 6.3 mm in diameter<br>L: 2-5mm | 6.3 mm in diameter<br>L: 3-5mm | N/A |
| | ABC | Alpha Bio | ARDS Dental Implants | |
| Standard<br>Ball<br>Attachment | H: 1-7mm | L: 0.5-6mm | H: 1-5mm | |
| Standard<br>Multi Unit | L: 1-4mm | L: 2.1 | L: 1-5mm | |
| Surface treatment | None | None | None | |

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Non-Clinical Performance Testing: Dynamic fatigue testing according to ISO 14801 was conducted to determine the abutments and implants are strong enough for their intended use. ABC implants exhibited a run out limit about the same or higher than other implant systems. Surface analysis was done to show the surface treatment does not adversely change the cytotoxicity of the materials. Biocompatibility testing was performed on the implants and abutments, and both substrates were found not to have cytotoxic potential, according to the requirements of ISO 10993-5.

All the materials are ones common in dental implants and abutments and abutments are made of titanium alloy which meets ASTM F136. Sterilization was conducted on the implants. Abutment steam sterilization was done. Package integrity testing and accelerated aging were conducted. Endotoxin testing according to USP 161 was conducted.

### Conclusion - Statement of Substantial Equivalence:

ABC Dental Implant System is substantially equivalent to Alpha-Bio Tec Dental Implant. System. They both have the similar indications for use, are of the same material, and have internal hexagon connections.

Performance testing demonstrates that the subject device exhibits equivalent performance to the predicate device. They use the same type of technology for their surface treatments and manufacturing. The abutments, healing caps, and angled abutments are offered in similar designs and heights. Performance testing showed that the subject device performs as well as the predicate device. Therefore, the data provided in this submission shows that the subject device is substantially equivalent to the predicate.