Implacil Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit and/or multi-unit restorations. When a one-stage surgical approach is applied, the Implacil Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Device Description

The Maestro line of Implacil Implant System is composed of three implant-to-abutment connections which are External Hex (HE), Internal Hex (HI) and Morse Taper AR Due Cone (CM AR). All of them are bone-level implants. The implants subject of this submission are threaded, self-tapping, root form endosseous dental implants used to support single or multiple restorations in immediate or conventional loading protocols. The subject devices are recommended for all bone density types, depending on the drill sequence used. The implants are made of commercially pure titanium (Grade 4) conforming to ASTM F67 and are surface treated to create a rough surface using an abrasive particle jet concept with controlled grain oxides, followed by acid etching creating uniform cavities in the implant surface. The Maestro implant line has radial channels (55 °) or chambers on their external surface.

AI/ML Overview

This document is a 510(k) Pre-Market Notification from the FDA for a dental implant system. It focuses on demonstrating the substantial equivalence of the "Implacil Implant System" to existing legally marketed devices, rather than presenting a study to prove acceptance criteria for a new device's performance.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for a study are not fully available or directly applicable to this type of regulatory submission.

However, I can extract the information that is present in the document that relates to performance and equivalence:

1. A table of acceptance criteria and the reported device performance

The document does not present specific acceptance criteria in the typical format of a performance study (e.g., sensitivity, specificity, accuracy thresholds). Instead, it demonstrates "substantial equivalence" to predicate devices based on shared technological characteristics and mechanical performance.

Characteristic	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Subject Device)
Intended Use	Identical to primary predicate (K183024)	Intended for placement in the maxillary or mandibular arch to provide support for single-unit and/or multi-unit restorations. Immediate loading with good primary stability and appropriate occlusal loading.
Raw Material	Identical to primary predicate (CPTi)	Commercially pure titanium (Grade 4) conforming to ASTM F67
Surface	Identical to primary predicate (Grit-blasted and acid-etched; Machined collar: h 1.0 mm)	Grit-blasted and acid-etched; Machined collar: h 1.0 mm
Sterilization	Identical to primary predicate (Provided sterile by irradiation)	Provided sterile by irradiation
Mechanical Performance	Supported by previous 510(k) for predicate (K183024)	Mechanical performance through dynamic fatigue testing according to ISO 14801 was supported by K183024.

Differences and Discussion

Design - presence of chambers: The subject device has chambers on its external surface, while the primary predicate does not. The document states this difference does not alter the external surface area with bone and expects no impact on mechanical performance. This is acknowledged as a "Difference" but mitigated by an analysis.
Implant diameter/lengths: The subject device's range of diameters and lengths is within the range of dimensions of the primary predicate and reference devices, leading to an "Equivalent" determination.

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

Test Set Sample Size: Not applicable. This submission relies on demonstrating substantial equivalence to previously cleared devices (predicates) and does not involve a new clinical or laboratory "test set" for a performance study.
Data Provenance: Not applicable for a new performance study. The data referenced is primarily existing regulatory clearances and standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth establishment by experts for a test set is not part of a substantial equivalence claim for a dental implant's mechanical properties, as opposed to, for example, an AI diagnostic device. The FDA reviewers and the submitters are the "experts" in assessing regulatory compliance and technical equivalence.

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

Not applicable. Adjudication methods are not used in this type of submission.

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. This is not an AI/software device; it's a physical dental implant.

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

Not applicable. This is not an AI/software device.

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

Ground Truth: For a physical medical device like this, the "ground truth" for its safety and effectiveness is established through adherence to recognized performance standards (e.g., ISO 14801 for dynamic fatigue testing), biocompatibility testing, material specifications (e.g., ASTM F67), and comparability to predicate devices with a history of safe and effective use. The "truth" is based on established engineering principles, material science, and regulatory precedent.

8. The sample size for the training set

Not applicable. This is not an AI/software device.

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

Not applicable. This is not an AI/software device.

Study Proving Acceptance Criteria:

The "study" in this context is the 510(k) Premarket Notification process itself, which demonstrates substantial equivalence to legally marketed predicate devices. The document explicitly states:

"Mechanical performance through dynamic fatigue testing according to ISO 14801 was supported by K183024." (K183024 is the primary predicate device).
"No clinical data were included in this submission."

This means that the device meets implied "acceptance criteria" by showing that its materials, manufacturing processes, intended use, and relevant performance characteristics (like mechanical strength assessed via ISO 14801) are either identical or acceptably similar to devices already cleared by the FDA. The submission effectively leverages the prior clearance of the predicate device (K183024) to support the safety and effectiveness of the new device, arguing that any differences (like the presence of chambers) do not raise new questions of safety or effectiveness.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Implacil de Bortoli Material Odontologico Ltda Thiago Toni Quality Manager Rua Vicente de Carvalho 178-182 Sao Paulo, Sao Paulo 01521020 BRAZIL

Re: K202832

Trade/Device Name: Implacil Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: April 19, 2021 Received: April 29, 2021

Dear Thiago Toni:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202832

Device Name Implacil Implant System

Indications for Use (Describe)

Implacil Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit and/or multi-unit restorations. When a one-stage surgical approach is applied, the Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Type of Use (Select one or both, as applicable)	☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

ADMINISTRATIVE INFORMATION

Sponsor	Implacil de Bortoli Material Odontologico LtdaRua Vicente de Carvalho 178-182São Paulo, São Paulo, Brazil 01521020Telephone: +55 (11) 3342-5100
Contact Person	Thiago ToniQuality Managerthiago@implacil.com.br
Date Prepared	25/May/2021
DEVICE NAME AND CLASSIFICATION
Trade/ Proprietary NameCommon Name	Implacil Implant SystemDental implant and abutment
Regulation NumberRegulation NameRegulation ClassProduct Code	21 CFR 872.3640Endosseous dental implantClass IIDZE
Classification PanelReviewing Branch	Dental Products PanelDental Devices Branch
PREDICATE DEVICE INFORMATION
Primary Predicate Device	K183024 - Implacil Implant System - Implacil de Bortoli MaterialOdontologico Ltda
Reference Devices	K170392 - S.I.N. Dental Implant System - S.I.N. Sistema de ImplanteNacional S.A.K192839 - DSP Implant System - D.S.P. Industrial Fireli

INDICATIONS FOR USE

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SUBJECT DEVICE DESCRIPTION

The implants subject of this submission are threaded, self-tapping, root form endosseous dental implants used to support single or multiple restorations in immediate or conventional loading protocols. The subject devices are recommended for all bone density types, depending on the drill sequence used.

The implants are made of commercially pure titanium (Grade 4) conforming to ASTM F67 and are surface treated to create a rough surface using an abrasive particle jet concept with controlled grain oxides, followed by acid etching creating uniform cavities in the implant surface. The Maestro implant line has radial channels (55 °) or chambers on their external surface.

HE implants are available in tapered (conical) root-forms designs in three diameters and platforms (3.5, 4.0 and 5.0 mm). For implants diameter 3.5, there are eight available lengths (8, 9, 10, 11, 12, 13, 14, 15), while for diameters 4.0 and 5.0 there are nine lengths ( 7, 8, 9, 10, 11, 12, 13, 14, 15).

HI implants are available in tapered (conical) root-forms designs in three diameters and platforms (3.5, 4.0 and 5.0 mm). For implants diameter 3.5, there are eight available lengths (8, 9, 10, 11, 12, 13, 14, 15), while for diameters 4.0 and 5.0 there are nine lengths (7, 8, 9, 10, 11, 12, 13, 14, 15).

CM AR implants are available in tapered (conical) root-form design, in four diameters (3.5, 4.0, 4.5 and 5.0 mm). For implants diameter 3.5, there are eight available lengths (8, 9, 10, 11, 12, 13, 14, 15), while for diameters 4.0, 4.5 and 5.0 there are nine lengths (7, 8, 9, 10, 11, 12, 13, 14, 15).

The compatible prosthetic components mate exclusively with the subject implants of the same implant-toabutment interface (HJ, HE, CM AR). All the compatible prosthetic components were cleared under K183024.

TECHNOLOGICAL CHARACTERISTICS

The subject device and the predicate devices have the same intended use and similar technological characteristics as shown in the tables below. Differences in the design features between the subject devices and the primary predicate device K183024 are addressed by comparison to the reference devices in design and range of dimensions.

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	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	Substantial Equivalence Discussion
Trade NameInformation	K202832 - Implacil Implant SystemImplacil de Bortoli Material OdontologicoLtda	K183024 – Implacil Implant SystemImplacil de Bortoli Material OdontologicoLtda	K192839 - DSP Implant SystemD.S.P. Industrial Eireli
Indication for Use	Implacil Implant System is intended forplacement in the maxillary or mandibulararch to provide support for single-unitand/or multi-unit restorations. When aone-stage surgical approach is applied, theImplacil Implant System is intended forimmediate loading when good primarystability is achieved and with appropriateocclusal loading.	Implacil Implant System is intended forplacement in the maxillary or mandibulararch to provide support for single-unitand/or multi-unit restorations. When aone-stage surgical approach is applied, theImplacil Implant System is intended forimmediate loading when good primarystability is achieved and with appropriateocclusal loading.	The DSP Implant System is intended to besurgically placed in the bone of the upper orlower jaw to provide support for prostheticdevices, such as artificial teeth, to restorechewing function. It may be used with singlestage or two-stage procedures, for single ormultiple unit restorations, and may beloaded immediately when good primarystability is achieved and with appropriateocclusal loading.	IdenticalThe indication for use statement isidentical to the primary predicate deviceand is within the scope of the referencedevice.
Implant-to-abutmentconnection	HE interface	HE interfaceHI interfaceConical connection (CM AR)	HE interface	IdenticalTo the primary predicate and referencedevices.
Raw Material	CPTi	CPTi	CPTi	IdenticalTo the primary predicate and referencedevices.
Surface	Grit-blasted and acid-etchedMachined collar: h 1.0 mm	Grit-blasted and acid-etchedMachined collar: h 1.0 mm	Grit-blasted and acid-etched.Machined collar: h 1.0 mm	EquivalentIdentical to the primary predicate andreference devices.
Design - presence ofchambers	Yes	No	No	DifferentThe presence of chambers in the externalsurface is the only difference between thesubject and primary predicate devicedesign. The substantial equivalence issupported by external surface areacomparison. No impact in mechanicalperformance is expected
	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
Trade NameInformation	K202832 - Implacil Implant System	K183024 – Implacil Implant System	K192839 - DSP Implant System	Substantial Equivalence Discussion
	Implacil de Bortoli Material Odontologico	Implacil de Bortoli Material Odontologico	D.S.P. Industrial Eireli
	Ltda	Ltda
Implant diameter:lengths (mm)	3.5: 8, 9, 10, 11, 12, 13, 14, 15	3.3: 8, 10, 11.5, 13, 15	3.3: 8.5, 10, 11.5, 13, 15, 17	EquivalentWithin the range of dimensions of theprimary predicate and reference devices.
		3.5: 7, 9, 11, 13, 15	3.8: 8.5, 10, 11.5, 13, 15
	4.0: 7, 8, 9, 10, 11, 12, 13, 14, 15	3.75: 8, 10, 11.5, 13, 15
		4.0: 7, 8, 9, 10, 11, 11.5, 13, 15	4.3: 8.5, 10, 11.5, 13, 15
		4.75: 8, 10, 11.5, 13, 15
	5.0: 7, 8, 9, 10, 11, 12, 13, 14, 15	5.0: 7, 9, 11, 13, 15	5.0: 8.5, 10, 11.5, 13, 15

Sterilization	Provided sterile by irradiation	Provided sterile by irradiation	Provided sterile by irradiation	IdenticalTo the primary predicate and referencedevices.
	SUBJECT DEVICES	PRIMARY PREDICATE DEVICE	REFERENCE DEVICES
Trade NameInformation	K202832 - Implacil Implant System	K183024 - Implacil Implant System	K170392- S.I.N. Dental ImplantSystem	K192839 - DSP Implant System	Substantial EquivalenceDiscussion
	Implacil de Bortoli MaterialOdontologico Ltda	Implacil de Bortoli MaterialOdontologico Ltda	S.I.N. Sistema de ImplanteNacional S.A.	D.S.P. Industrial Eireli
Indication for Use	Implacil Implant System isintended for placement in themaxillary or mandibular arch toprovide support for single-unitand/or multi-unit restorations.When a one-stage surgicalapproach is applied, the ImplacilImplant System is intended forimmediate loading when goodprimary stability is achieved andwith appropriate occlusalloading.	Implacil Implant System isintended for placement in themaxillary or mandibular arch toprovide support for single-unitand/or multi-unit restorations.When a one-stage surgicalapproach is applied, the ImplacilImplant System is intended forimmediate loading when goodprimary stability is achieved andwith appropriate occlusal loading.	S.I.N. Dental Implant System isintended for placement in themaxillary or mandibular arch toprovide support for single-unit ormulti-unit restorations. When aone-stage surgical approach isapplied, the S.I.N. Dental ImplantSystem is intended for immediateloading when good primarystability is achieved and withappropriate occlusal loading.Implants with lengths less than 7mm are intended for delayedloading only.	The DSP Implant System isintended to be surgically placedin the bone of the upper orlower jaw to provide support forprosthetic devices, such asartificial teeth, to restorechewing function. It may be usedwith single stage or two-stageprocedures, for single or multipleunit restorations, and may beloaded immediately when goodprimary stability is achieved andwith appropriate occlusalloading.	IdenticalThe indication for use statementis identical to the primarypredicate device and is within thescope of the reference devices.
Implant-to-abutmentconnection	HI interface	HE interfaceHI interfaceConical connection (CM AR)	Conical connection (CM)	HE interface	IdenticalTo the primary predicate device.
Raw Material	CPTi	CPTi	CPTi	CPTi	IdenticalTo the primary predicate andreference devices.
Surface	Grit-blasted and acid-etchedMachined collar: h 1.0 mm	Grit-blasted and acid-etchedMachined collar: h 1.0 mm	Grit-blasted and acid-etched	Grit-blasted and acid-etchedMachined collar: h 1.0 mm	IdenticalTo the primary predicate andreference devices for the grit-blasted and acid-etched surfaceand identical to the primarypredicate and reference deviceK192839 for the machined collarheight

Table 5.1: SE comparison on Maestro HE implants

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K202832- Implacil Implant System

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Table 5.2: SE comparison on Maestro HI implants

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K202832- Implacil Implant System

	SUBJECT DEVICES	PRIMARY PREDICATE DEVICE	REFERENCE DEVICES
Trade NameInformation	K202832 - Implacil Implant System	K183024 - Implacil Implant System	K170392- S.I.N. Dental ImplantSystem	K192839 - DSP Implant System	Substantial EquivalenceDiscussion
	Implacil de Bortoli MaterialOdontologico Ltda	Implacil de Bortoli MaterialOdontologico Ltda	S.I.N. Sistema de ImplanteNacional S.A.	D.S.P. Industrial Eireli
Design - presence ofchambers	Yes	No	No	No	Different
					The presence of chambers in theexternal surface is only differencebetween the subject and primarypredicate device design. Thesubstantial equivalence issupported by external surfacearea comparison. No impact inmechanical performance isexpected.
Implant diameter:lengths (mm)			2.9: 10, 11.5, 13		Equivalent
		3.3: 8, 9, 11, 13, 15		3.3: 8.5, 10, 11.5, 13, 15, 17
	3.5: 8, 9, 10, 11, 12, 13, 14, 15	3.5: 8, 9, 11, 13, 15	3.5: 8.5, 10, 11.5, 13, 15		Within the range of dimensions
		3.75: 7, 9, 11, 13, 15	3.8: 8.5, 10, 11.5, 13, 15	3.8: 8.5, 10, 11.5, 13, 15	of the primary predicate and
	4.0: 7, 8, 9, 10, 11, 12, 13, 14, 15	4.0: 8, 9, 11, 13, 15	4.0: 5, 6, 7	4.3: 8.5, 10, 11.5, 13, 15	reference devices.
		4.3: 7, 9, 11, 13, 15	4.3: 8.5, 10, 11.5, 13, 15
		4.75: 7, 9, 11, 13, 15	4.5: 8.5, 10, 11.5, 13, 15	5.0: 8.5, 10, 11.5, 13, 15
	5.0: 7, 8, 9, 10, 11, 12, 13, 14, 15	5.0: 7, 9, 11, 13, 15	5.0: 5, 6, 7, 8.5, 10, 11.5, 13, 15
Sterilization	Provided sterile by irradiation	Provided sterile by irradiation	Provided sterile by irradiation	Provided sterile by irradiation	Identical
					To the primary predicate andreference devices.

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	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
Trade NameInformation	K202832 - Implacil Implant SystemImplacil de Bortoli Material OdontologicoLtda	K183024 – Implacil Implant SystemImplacil de Bortoli Material OdontologicoLtda	K170392- S.I.N. Dental Implant SystemS.I.N. Sistema de Implante Nacional S.A.	Substantial Equivalence Discussion
Indication for Use	Implacil Implant System is intended forplacement in the maxillary or mandibulararch to provide support for single-unitand/or multi-unit restorations. When aone-stage surgical approach is applied, theImplacil Implant System is intended forimmediate loading when good primarystability is achieved and with appropriateocclusal loading.	Implacil Implant System is intended forplacement in the maxillary or mandibulararch to provide support for single-unitand/or multi-unit restorations. When a one-stage surgical approach is applied, theImplacil Implant System is intended forimmediate loading when good primarystability is achieved and with appropriateocclusal loading.	S.I.N. Dental Implant System is intended forplacement in the maxillary or mandibulararch to provide support for single-unit ormulti-unit restorations. When a one-stagesurgical approach is applied, the S.I.N.Dental Implant System is intended forimmediate loading when good primarystability is achieved and with appropriateocclusal loading. Implants with lengths lessthan 7 mm are intended for delayed loadingonly.	EquivalentThe indication for use statement isidentical to the primary predicate deviceand within the scope of the referencedevice.
Implant-to-abutmentconnection	Conical connection (CM AR)	HE interfaceHI interfaceConical connection (CM AR)	Conical connection (CM)	IdenticalTo the primary predicate device.
Raw Material	CPTi	CPTi	CPTi	IdenticalTo the primary predicate device andreference devices.
Surface	Grit-blasted and acid-etched	Grit-blasted and acid-etched	Grit-blasted and acid-etched	IdenticalTo the primary predicate device andreference device.
Design - presence ofchambers	Yes	No	No	DifferentThe presence of chambers in the externalsurface is only difference between thesubject and primary predicate devicedesign. The substantial equivalence issupported by external surface areacomparison. No impact in mechanicalperformance is expected.
Trade NameInformation	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE	Substantial Equivalence Discussion
	K202832 - Implacil Implant SystemImplacil de Bortoli Material OdontologicoLtda	K183024 – Implacil Implant SystemImplacil de Bortoli Material OdontologicoLtda	K170392- S.I.N. Dental Implant SystemS.I.N. Sistema de Implante Nacional S.A.
Implant diameter:lengths (mm)	3.5: 8, 9, 10, 11, 12, 13, 14, 15	3.3: 8, 9, 11, 13, 153.5: 8, 9, 11, 13, 153.75: 7, 9, 11, 13, 154.0: 8, 9, 11, 13, 154.3: 7, 9, 11, 13, 154.75: 7, 9, 11, 13, 155.0: 7, 9, 11, 13, 15	2.9: 10, 11.5, 133.5: 8.5,10, 11.5, 13, 153.8: 8.5, 10, 11.5, 13, 154.0: 5, 6, 74.3: 8.5,10, 11.5, 13, 154.5: 8.5, 10, 11.5, 13, 155.0: 5, 6, 7, 8.5,10, 11.5, 13, 15	EquivalentWithin the range of dimensions of theprimary predicate and reference device.
Sterilization	Provided sterile by irradiation	Provided sterile by irradiation	Provided sterile by irradiation	IdenticalTo the primary predicate device andreference device.

Table 5.3: SE comparison on Maestro CM AR implants

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K202832- Implacil Implant System

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The indication for use statement is identical to the primary predicate device.

The subject HE, HI and CM AR implants are substantially equivalent to the primary predicate device K183024, and reference devices K170392 and K192839, in designs and range of dimensions.

For all the three implant lines, there is a difference in design between subject and primary predicate device which is the presence of the chambers in the external surface of the device. The chambers do not alter the external surface area of the implants that with the bone, therefore, substantial equivalence is supported by the surface area analysis comparison. No impact in mechanical performance is expected.

PERFORMANCE DATA

The implants are made of unalloyed titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700). The type of titanium is the same to that used for fabrication of the primary predicate devices cleared under K183024. The subject devices undergo to the same manufacturing processes, including surface treatment step to the cited predicate device.

The sterilization method, sterile barrier shelf life, package integrity, and pyrogenicity monitoring for the subject device are unchanged from the K183024 submission. Mechanical performance through dynamic fatigue testing according to ISO 14801 was supported by K183024.

No clinical data were included in this submission.

CONCLUSION

The documentation submitted in this premarket notification demonstrates that the subject devices have comparable features and performance and, therefore, are substantially equivalent to the identified primary predicate and reference devices.

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.