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 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. 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.

AI/ML Overview

The provided text does not describe an AI/ML powered device, but rather a dental implant system (ABC Dental Implant System). Therefore, the information typically requested for AI/ML device studies (such as sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) is not applicable here.

The document pertains to a 510(k) premarket notification for a Class II medical device, the ABC Dental Implant System. The acceptance criteria and the "study" proving the device meets these criteria are primarily based on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance testing and comparison of characteristics.

Here's an interpretation of "Acceptance Criteria" and "Device Performance" based on the provided 510(k) summary, reframed to fit the context of a dental implant system:

1. Acceptance Criteria and Reported Device Performance (Non-AI/ML Context)

The "acceptance criteria" for a dental implant system in a 510(k) submission are generally to demonstrate that the new device is as safe and effective as a legally marketed predicate device. This is primarily shown through non-clinical performance testing and a detailed comparison of characteristics.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (ABC Dental Implant System)
Functional Equivalence: The device should perform its intended function similarly to the predicate.	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. Also indicated for immediate loading when good primary stability is achieved..." This matches the predicate and reference devices.
Material Equivalence/Biocompatibility: Materials should be safe and biologically compatible for their intended use.	Made of ASTM F136 Ti 6Al 4V ELI (Grade 5), which is common in dental implants. Biocompatibility testing (according to ISO 10993-5) showed no cytotoxic potential.
Mechanical Strength/Fatigue Life: The implant and abutment system must withstand chewing forces over time.	Dynamic fatigue testing according to ISO 14801 was conducted. "ABC implants exhibited a run out limit about the same or higher than other implant systems."
Surface Treatment Properties: The surface treatment should be safe and not adversely affect cytotoxicity or performance.	Grit blasted and acid etched surface. Surface analysis showed the treatment "does not adversely change the cytotoxicity of the materials."
Sterility & Packaging Integrity: The device must be sterile and maintain sterility until use.	Sterilization was conducted on implants (Gamma Radiation). Abutment steam sterilization was done. Package integrity testing and accelerated aging were conducted. Endotoxin testing performed according to USP 161.
Design/Dimensional Equivalence: Key design features and dimensions should be comparable to support substantial equivalence.	Detailed comparison table shows similar dimensions (diameter and length ranges), internal hex connection, screw-shaped design, and available abutment types and dimensions to the predicate (Alpha-Bio Tec® Dental Implant System) and reference devices (ARDS Dental Implants).
Manufacturing/Quality Control: Device production should follow good manufacturing practices.	While not explicitly detailed as "acceptance criteria" performance, the 510(k) process implicitly requires adherence to Quality System (QS) regulation (21 CFR Part 820). The letter mentions "good manufacturing practice requirements."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not applicable. The "test set" here refers to non-clinical laboratory testing (e.g., fatigue testing, biocompatibility testing) of the device itself, not a clinical study involving a dataset of patient images or outcomes. The data provenance would be the manufacturing site (Israel) and the testing laboratories that conducted the non-clinical tests. These are physical device tests, not data analysis tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in the context of AI/ML, refers to clinically validated diagnoses or measurements from patient data. For a dental implant system, the "ground truth" for the device's performance is established by standardized material and mechanical testing protocols (e.g., ISO standards), not by human experts adjudicating clinical cases.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as there's no clinical "test set" requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable, as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this is not an AI/ML device. The "standalone performance" is the mechanical and material performance of the physical implant device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this type of device, the "ground truth" for proving its safety and effectiveness is primarily established through:

Standardized Non-Clinical Testing: Adherence to established international standards (e.g., ISO 14801 for fatigue testing, ISO 10993-5 for biocompatibility).
Material Specifications: Conformance to recognized material standards (e.g., ASTM F136 for Ti-6Al-4V ELI).
Comparison to Predicate Device: Demonstrating that the new device's characteristics (design, materials, indications for use, performance) are sufficiently similar to a predicate device that has already been cleared by the FDA.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device. There is no "training set" in the AI/ML sense.

9. How the ground truth for the training set was established

Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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.

{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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K202092

Device Name ABC Dental Implant System

Indications for Use (Describe)

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)

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}------------------------------------------------

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: +972 52 600 8222 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.

{4}------------------------------------------------

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:

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(Bolero)	Alpha-Bio Tec® DentalImplant System (SPI DFINEO)	ARDS Dental Implants(Classic and Premium CIC)
IntendedUse/Indication	The ABC Dental ImplantsSystem is indicated for use insurgical and restorativeapplications for placement inthe bone of the upper or lowerjaw to provide support forprosthetic devices, such asartificial teeth, to restore thepatient's chewing function.The ABC Dental ImplantsSystem is also indicated forimmediate loading when goodprimary stability is achievedand with appropriate occlusalloading	The Alpha-Bio Dental ImplantSystem® isindicated for use in surgicaland restorative applicationsforplacement in the bone of theupper or lower jaw to providesupportfor prosthetic devices, such asartificial teeth, to restorethe patient's chewing function.The Alpha-Bio Dental ImplantSystem® is indicated also forimmediate loading when goodprimary stability is achievedand with appropriate occlusalloading.	ARDS dental implants areindicated for use in surgicaland restorativeapplications for placement inthe bone of the upper andlower jaw to providesupport for prosthetic devicesto restore the patient'schewing function. ARDSdental implants are indicatedfor two-stage surgery.
Site/Bone type	Bolero is suitable for densebone D1 / D2 and soft boneD3 / D4 in the upper or lowerjaw.	SPI does not state a specificsite or bone site indication.DFI is referred by themanufacturer as Suitable forall bone types, ideal for use inbone types D2 and D3.NEO is referred by themanufacturer as Suitable forall bone types D2, D3 and D4.	Classic will optimally be usedfor softer bone when bonecompression around theimplant can be donePremium recommended to beused also for harder and morecondensed bones such as typeD1CIC is referred by themanufacturer as Suitable forall bone types, ideal for use inbone types D2 D3 and D4.
Population	Edentulous and partiallydentate patients	Edentulous and partiallydentate patients	Edentulous and partiallydentate patients
Performance	Intended to provide supportfor prosthetic devices, such asartificial teeth, in order to	Intended to provide supportfor prosthetic devices, such asartificial teeth, in order to	Intended to provide supportfor prosthetic devices, such asartificial teeth, in order to
Characteristic	ABC Dental Implants(Bolero)	Alpha-Bio Tec® DentalImplant System (SPI DFINEO)	ARDS Dental Implants(Classic and Premium CIC)
	restore the patients' chewingfunction.	restore the patients' chewingfunction.	restore the patients' chewingfunction.
Device Design	Screw-shaped Titanium dentalimplant -Bolero parallel	Screw-shaped Titanium dentalimplantSPI ConicalDFI parallelNEO Conical	Screw-shaped Titanium dentalimplantClassic - ConicalPremium - ParallelCIC- Conical
Placement Method	One and two-stage procedure.	One and two-stage procedure.	Two-stage procedure.
Material	Ti-6Al-4V Eli ASTM F136(Grade 5)	Ti-6Al-4V Eli (Grade 5)	Ti-6Al-4V Eli (Grade 5)
Dimensions andtolerances Diameter(mm)	Bolero - 3.3, 3.75, 4.2, 5mm±0.1mm	SPI-3.3, 3.75, 4.2, 5, 6mm±0.1mmDFI- 3.3, 3.75, 4.2, 5mm±0.1mmNEO- 3.75, 4.2, 5.0mm±0.1mm	Classic - 3.3, 3.75, 4.2, 5,6mm ±0.1mmPremium -3.3, 3.75, 4.2, 5,6mm ±0.1mmCIC- 3.5mm ±0.1mm
Dimensions andtolerances length(mm)	6, 8, 10, 11.5, 13,16mm±0.1mm	6, 8, 10, 11.5, 13,16mm±0.1mm	8, 10, 11.5, 13, 16mm ±0.1mm
Anti-rotationalfeatures-internalexternal hexagonal.etc.	internal hexagonal	internal hexagonal	internal hexagonal
Device features	Self-tapping and self-condensing tapered titaniumscrew implant	Self-tapping and self-condensing tapered titaniumscrew implant with variablethread design	Self-tapping titanium screwimplant with dual threaddesign
Flat axial surfacefeatures on theimplant	None	None	None
Internal hex.threads(inch)	1#72	1#72	1#72
Abutmentconnection	Hexagon + screw	Screw or hexagon + screw	Screw or hexagon + screw
Surface treatment	Sandblasting, followed bycleaning by acid treatment	Sandblasting, followed bycleaning by acid treatment	Sandblasting, followed bycleaning by acid treatment
Packaging	Double vial	Vial and a Blister	Double vial
Implant Sterilization	Gamma Radiation	Gamma Radiation	Gamma Radiation
Components	The ABC Dental ImplantSystem consists of one andtwo-stage endosseous formdental implants with aninternal hexagonalconnection; cover screw andhealing caps; abutmentsystems and superstructures;surgical instruments (*).	The Alpha-Bio Dental ImplantSystem® consists of one andtwo-stage endosseous formdental implants, with aninternal hexagonal connection;cover screws and healing caps;abutment systems andSuperstructures; surgicalinstruments (*).	The Alpha-Bio Dental ImplantSystem® consists of one andtwo-stage endosseous formdental implants, with aninternal hexagonal connection;cover screws and healing caps;abutment systems andSuperstructures; surgicalinstruments (*).
Abutments[refer to abutmentcomparison in therows below]	Straight & up to 25°	Straight & up to 25°	Straight & up to 25°
Abutment Type/Dimensions		ABC	Alpha Bio	ARDS Dental Implants
	Standardabutment	screw thread - 1#72 inch.Diameter: 3.8, 4.5, 5.5	screw thread - 1#72 inch.Diameter: 3.5, 4.5, 5.5 mm	screw thread - 1#72 inch.Diameter: Slim - 3.8mmNormal - 4.5mm,Wide - 5.5,6.3mm
	Standardabutmentwithshoulder	screw thread - 1#72 inch.Diameter:3.8, 4.5, 5.5mm.Shoulder height: 1, 2, 3,4mm.	screw thread - 1#72 inch.Diameter: 4.5, 5.5mmShoulder height: 1,2,3,4mm.	screw thread - 1#72 inch.Diameter: normal -4.5mm, wide - 5.5mm.Shoulder height 1-4mm
	15° Angularabutment	screw thread - 1#72 inch.Diameter: 4.5, mm.	screw thread - 1#72 inch.Diameter: 4.5, mm.	screw thread - 1#72 inch.diameter- normal-4.5mm, wide- 5.5 mm
	25° Angularabutment	screw thread - 1#72 inch.Diameter: 4.5, mm.	screw thread - 1#72 inch.Diameter: 4.7mm.	screw thread - 1#72 inch.diameter- 4.7mm
	15° Angularabutmentwithshoulder	screw thread - 1#72 inch.Diameter: 4.5, mm.Shoulder height 1,2,3,4mm.	screw thread - 1#72 inch.Diameter: 4.7mm.Shoulder height 1,2,3mm.	screw thread - 1#72 inch.Diameter -4.5 mm.Shoulder height 1-2mm
	25° Angularabutmentwithshoulder	Connection: Internalhexagon - 2.43 mmdiameter,screw thread - 1#72 inch.Diameter:4.5, mm.Shoulder height 1,2,3,4mm.	Connection: Internalhexagon - 2.43 mmdiameter.screw thread - 1#72 inch.Diameter: 4.7mm.Shoulder height 1,2,3mm.	Connection: Internalhexagon - 2.43 mmdiameter,screw thread - 1#72 inch.Diameter - 4.7 mm.Shoulder height 1-2mm
	StandardHealingCap	4.6 mm in diameterL: 2-8mm	4.6 mm in diameterL: 2-7mm	4.5 mm in diameterL: 3-5mm
	StandardHealingCap Narrow	3.8 mm in diameterL: 2-7mm	3.85 mm in diameterL: 3-5mm	3.8 mm in diameterL: 3-5mm
	StandardHealingCap Wide	5.5 mm in diameterL: 2-7mm	5.5 mm in diameterL: 3-5mm	4.7 mm in diameterL: 3-5mm
	StandardHealingCap ExtraWide	6.3 mm in diameterL: 2-5mm	6.3 mm in diameterL: 3-5mm	N/A
	ABC	Alpha Bio	ARDS Dental Implants
StandardBallAttachment	H: 1-7mm	L: 0.5-6mm	H: 1-5mm
StandardMulti Unit	L: 1-4mm	L: 2.1	L: 1-5mm
Surface treatment	None	None	None

{5}------------------------------------------------

{6}------------------------------------------------

{7}------------------------------------------------

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.

Regulation Number and Section

§ 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.