Implacil Implant System

• K Number: K183024
• Device Name: Implacil Implant System
• Manufacturer: Implacil de Bortoli Material Odontologico Ltda
• Date Cleared: 2020-02-13 ( 469 days)
• Product Code: DZE , NHA
• Regulation Number: 872.3640
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: K062931 , K072642 , K090452 , K101207 , K101945 , K133510 , K140440 , K163060 , K163634 , K170392 , K170608 , K173819 , K173902 , K180282 , K170398
• Predicate For: K202832

Intended Use

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 is applied, the Implacil Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Device Description

Implacil Implant System is composed of three implant lines that are divided according to the implant-toabutment interface: External Hex (HE), Internal Hex (HI) and Morse Taper AR Due Cone (CM AR). HE and HI lines are composed of tissue-level implants while CM AR line of bone-level implants. Each implant line is composed of implants and related prosthetic components available in multiple designs (temporary, screwed, cementable, angled, straight, UCLA, ball).

HE implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm). Cylindrical implants are provided in four diameters (3.3, 3.75, 4.0 and 4.75 mm), three platforms (3.5, 4.0 and 5.0 mm) and five lengths (8.0, 10.0, 11.5, 13.0 and 15.0 mm). HE cylindrical implants of diameters 3.75 and 4.0 share the same platform of 4.0 mm.

HI implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm). For diameters 3.5 and 4.0 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 5.0 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. Cylindrical implants are provided in four diameters (3.3, 3.75, 4.3 and 4.75 mm) and three platforms (3.5, 4.0 and 5.0 mm). For diameter 3.3 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 3.75 and 4.3 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. HI cylindrical implants of diameters 3.75 and 4.3 share the same platform of 4.0 mm.

CM AR implant line implants are available in conical root-form design only, in four diameters (3.5, 4.0, 4.5 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm).

lmplacil implants are made of commercially pure titanium (ASTM F67). Implacil prosthetic components are made of commercially pure titanium (ASTM F67) or titanium alloy (ASTM F136). Implant System screws (abutment screw, UCLA screws and coping screws) are made of titanium alloy (ASTM F136).

The subject device abutments components mate exclusively with the subject implants of the same line (HJ, HE, CM AR).

AI/ML Overview

The provided document is a 510(k) Summary for a dental implant system. It outlines the device description, intended use, and a comparison to predicate and reference devices to demonstrate substantial equivalence. Crucially, this document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of AI/ML-based medical devices.

The "Performance Data" section explicitly states: "No clinical data were included in this submission." Instead, it lists non-clinical data for physical and material properties of the dental implants, such as sterilization validation, shelf life testing, biocompatibility, and mechanical performance (fatigue and torsional loading).

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth establishment, or MRMC comparative effectiveness studies, as these types of studies are not described in this 510(k) submission for a traditional medical device (dental implants), which are not a software device or AI/ML-based device.

If you are looking for information on acceptance criteria and study data for AI/ML-based medical devices, you would need to consult a different type of FDA submission, specifically for software as a medical device (SaMD) or AI-enabled medical devices, where such performance data would be critical for demonstrating safety and effectiveness.

Summary

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

Image /page/0/Picture/0 description: The image contains 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.

February 13, 2020

Implacil de Bortoli Material Odontologico Ltda c/o Janine Treter Regulatory Affairs Specialist PR Serviços Regulatórios Administrativos Ltda Rua Alice Além Saadi, 855/ 2402 Ribeirão Preto, São Paulo 14096-570 BRAZIL

Re: K183024

Trade/Device Name: Implacil Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: January 13, 2020 Received: January 16, 2020

Dear Janine Treter:

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.

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

{1}------------------------------------------------

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

Sincerely,

Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K183024

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 is applied, the Implacil 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)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ 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

[e-mail]

"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}------------------------------------------------

510(k) Summary

ADMINISTRATIVE INFORMATION

Sponsor
---------	--

Sponsor	Implacil de Bortoli Material Odontologico Ltda
	Rua Vicente de Carvalho 178-182
	São Paulo, São Paulo, Brazil 01521020

Contact Person and Preparer Janine Treter, PhD Regulatory Affairs Specialist Passarini Regulatory Affairs PR Serviços Regulatórios Administrativos Ltda E-Mail: [e-mail] Telephone [phone]

Date Prepared

13/Feb/2020

DEVICE NAME AND CLASSIFICATION

Trade/ Proprietary Name	Implacil Implant System
Common Name	Dental implant and abutment
Primary Classification Name	Endosseous dental implant
Primary Classification Regulation	21 CFR 872.3640, Class II
Primary Product Code	DZE, NHA

Classification Panel	Dental Products Panel
Reviewing Branch	Dental Devices Branch

PREDICATE DEVICE INFORMATION

Primary Predicate Device

Reference Devices

K170398 – S.I.N. Dental Implant System – S.I.N. Sistema de Implante Nacional S.A. K062931 – IMPLUS - LEADER Italia S.R.O K072642 - BIOMET 3i Dental Abutments and Restorative Components - Biomet 3i, Inc.

K090452 - Neoss Implant System 03,25 - Neoss Limited

K101207 - Neodent Implant System -JJGC Industria e Comercio de Materiais Dentarios S.A.

K101945- Neodent Implant System - JJGC Industria e Comercio de Materiais Dentarios S.A.

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

K133510 - Neodent Implant System - JJGC Industria e Comercio de Materiais Dentarios S.A.

K140440 - Noris Medical Dental Implants System - Noris Medical, Ltd.

K163060 -Deep Conical (DC) Implants and Accessories - Southern Implants (Pty) Ltd

K163634 - External Hex Implants - Southern Implants (Pty) Ltd

K170392 - S.I.N. Dental Implant System - S.I.N. Sistema de Implante Nacional S.A.

K170608 - UF(II) Implant System - DIO Corporation

K173819 – MyPlant II Implant System Hager & Meisinger GmbH

K173902 - Neodent Implant System - GM Line - JJGC Industria e Comercio de Materiais Dentarios S.A.

K180282 - MIS Internal Hex Dental Implant System -MIS Implants Technologies Ltd.

INDICATIONS FOR USE

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.

SUBJECT DEVICE DESCRIPTION

Implacil Implant System is composed of three implant lines that are divided according to the implant-toabutment interface: External Hex (HE), Internal Hex (HI) and Morse Taper AR Due Cone (CM AR). HE and HI lines are composed of tissue-level implants while CM AR line of bone-level implants. Each implant line is composed of implants and related prosthetic components available in multiple designs (temporary, screwed, cementable, angled, straight, UCLA, ball).

HE implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm). Cylindrical implants are provided in four diameters (3.3, 3.75, 4.0 and 4.75 mm), three platforms (3.5, 4.0 and 5.0 mm) and five lengths (8.0, 10.0, 11.5, 13.0 and 15.0 mm). HE cylindrical implants of diameters 3.75 and 4.0 share the same platform of 4.0 mm.

HI implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm). For diameters 3.5 and 4.0 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 5.0 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. Cylindrical implants are provided in four diameters (3.3, 3.75, 4.3 and 4.75 mm) and three platforms (3.5, 4.0 and 5.0 mm). For diameter 3.3 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 3.75 and 4.3 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. HI cylindrical implants of diameters 3.75 and 4.3 share the same platform of 4.0 mm.

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

CM AR implant line implants are available in conical root-form design only, in four diameters (3.5, 4.0, 4.5 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm).

lmplacil implants are made of commercially pure titanium (ASTM F67). Implacil prosthetic components are made of commercially pure titanium (ASTM F67) or titanium alloy (ASTM F136). Implant System screws (abutment screw, UCLA screws and coping screws) are made of titanium alloy (ASTM F136).

The subject device abutments components mate exclusively with the subject implants of the same line (HJ, HE, CM AR).

TECHNOLOGICAL CHARACTERISTICS

The subject device and the predicate devices have the same intended use as and technological characteristics as shown in the tables below. Differences in the design features between the subject devices and the primary predicate device K170398 are addressed by comparison to the reference devices.

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

Table 5.1: Comparison on indication for use statement
	KNUMBER/ MANUFACTURER	INDICATION FOR USE STATEMENT
SUBJECT DEVICE	K183024 – Implacil Implant SystemImplacil de Bortoli Material OdontologicoLtda	Implacil Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit and/or multi-unitrestorations. When a one-stage surgical approach is applied, the Implacil Implant System is intended for immediate loading when goodprimary stability is achieved and with appropriate occlusal loading.
PRIMARY PREDICATEDEVICE	K170398 - S.I.N. Dental Implant SystemS.I.N. Sistema de Implante Nacional S.A	S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unitrestorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when goodprimary stability is achieved and with appropriate occlusal loading. Revolution Compact with a 6 mm length is intended for delayed loadingonly.
REFERENCE DEVICES	K062931 – IMPLUSLEADER Italia S.R.O	IMPLUS implant fixtures are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches in order to providesupport for fixed and/or removal prosthetics in order to restore original features and masticatory functions.Implus implant fixtures are indicated for permanent use.Implus implant fixtures are disposable and are for one-time use only. These fixtures are not to be recleaned or re-sterilized.
	K072642 – BIOMET 3i Dental Abutments andRestorative ComponentsBiomet 3i, Inc.	BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implant to support a prosthetic device in a partially orcompletely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible ormaxilla. The prosthesis can be screw retained or cement retained.Restorative Components* Temporary Healing Abutments are intended for use to shape and maintain the soft tissue opening during healing.* Castable restorative components are intended for use as accessories to endosseous dental implants to aid in the fabrication of dentalprosthetics.* Screw components are intended for use as accessories to endosseous dental implants for retention of screw retained abutments to thedental implant.
	K090452 – Neoss Implant System 03,25Neoss Ltd	The Neoss Implant System 03,25 is for single-stage and two-stage surgical procedures and cement or screw retained restorations.The Neoss Implant System 03,25 are intended for immediate loading on single tooth and /or multiple tooth applications recognizing sufficientbone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.The Neoss Implant 03,25 abutments are designed to be connected to the Neoss implants and intended for use as an aid in prostheticrehabilitation.
	K101207 - Neodent Implant SystemJJGC Industria e Comercio de MateriaisDentarios S.A.	The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prostheticdevices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multipleunit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multipletooth applications may be rigidly splinted.
	KNUMBER/ MANUFACTURER	INDICATION FOR USE STATEMENT
REFERENCE DEVICES	K101945- Neodent Implant SystemJJGC Industria e Comercio de MateriaisDentarios S.A.	The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prostheticdevices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multipleunit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multipletooth applications may be rigidly splinted.
	K133510 - Neodent Implant SystemJJGC Industria e Comercio de MateriaisDentarios S.A.	The Neodent Implant System is intended to be surgically placed in the bone of the upper or lowerjaw to provide support for prostheticdevices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multipleunit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multipletooth applications may be rigidly splinted.
	K163060 -Deep Conical (DC) Implants andAccessoriesSouthern Implants (Pty) Ltd	Southern Implants Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with thefollowing clinical protocols:• replacing single and multiple missing teeth in the mandible and maxilla,• immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge,• immediate loading in all indications, except in single tooth situations on implants shorter than 8mm or in soft bone (type IV) whereimplant stability may be difficult to obtain and immediate loading may not be appropriate.The intended use for 3.0 Deep Conical implants is limited to replacement of maxillary lateral incisors and mandibular incisors
	K163634 - External Hex ImplantsSouthern Implants (Pty) Ltd	Southern Implants' External Hex Implants are intended for surgical placement in the upper or lowerjaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.Southern Implants' External Hex Implants are intended for immediate function when good primarystability with appropriate occlusal loading is achieved.
	K170608 - UF(II) Implant SystemDIO Corporation	The UF(II) Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single ormultiple units' prosthetic attachment to restore a patient's chewing function. The UF(II) Implant System (Ø3.8 ~ Ø5.5) can be placed with aconventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process forimmediate loading when good primary stability is achieved with appropriate occlusal loading.
	K170392 - S.I.N. Dental Implant SystemS.I.N. Sistema de Implante Nacional S.A	S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unitrestorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when goodprimary stability is achieved and with appropriate occlusal loading. Implants with lengths less than 7 mm are intended for delayed loadingonly.
	K173819 – MyPlant II Implant SystemHager & Meisinger GmbH	The MyPlant II implants are surgically placed in the maxilla or mandible to enable prosthetic restorations in edentulous or partially edentulouspatients. The implants are to be used exclusively with MyPlant II abutments and prosthetic components. The abutments serve for prostheticrestorations and can include individual crowns, bridges, partial or full prostheses. Abutments can be used for single tooth restorations or forthe restoration of several teeth. The implants are intended for delayed loading with two surgical interventions. In case of appropriate primarystability (35 Ncm), immediate temporary restoration with appropriate occlusal load can also be performed.
	KNUMBER/ MANUFACTURER	INDICATION FOR USE STATEMENT
REFERENCE DEVICES	K173902 - Neodent Implant System - GMLine	The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prostheticdevices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multipleunit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
	JJGC Industria e Comercio de MateriaisDentarios S.A.
	K180282 - MIS Internal Hex Dental ImplantSystem	MIS dental implant systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prostheticdevices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may beimmediately loaded when good primary stability is achieved and the occlusal load is appropriate.
	MIS Implants Technologies Ltd.	Narrow implants (Ø3.3mm & UNO) are indicated for use in surgical and restorative applications for placement only in the mandibular central,lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificialteeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.The long MIS (18 & 20 mm) implants can be used in a tilted manner.MIS short implants are to be used only with straight abutments.M4 short implants are indicated for delayed loading only.

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

{8}------------------------------------------------

{9}------------------------------------------------

Page 7 of 22

Table 5.2: SE comparison on HE implants
	SUBJECT DEVICES	PRIMARY PREDICATE DEVICE		REFERENCE DEVICES
Trade Name	K183024 - Implacil ImplantSystemImplacil de Bortoli MaterialOdontologico Ltda	K170398 - S.I.N. Dental ImplantSystemS.I.N. Sistema de ImplanteNacional S.A.	K101207 – Neodent ImplantSystemJJGC Industria e Comercio deMateriais Dentarios S.A.	K062931 - IMPLUSLEADER Italia S.R.O.	K163634 – External Hex ImplantSouthern Implants (Pty) Ltd.November 6, 2017
Information
Implant-to-abutment connection	HE interface	HE interface	HE interface	HE interface	HE interface
Raw Material	CPTi	CPTi	CPTi	CPTi	CPTi
Surface	Grit-blasted and acid-etched	Acid-etched and HA	Grit-blasted and acid-etched	Sand-blasted and acid-etched	Grit-blasted and acid-etchedMachine collar versionsavailable
Root type design	Cylindrical	Cylindrical	Cylindrical	Cylindrical	Cylindrical
	Tapered		Tapered	Tapered	Tapered
Implant diameter (mm)	Cylindrical:3.3: 8, 10, 11.5, 13, 153.75: 8, 10, 11.5, 13, 154.0: 8, 10, 11.5, 13, 154.75: 8, 10, 11.5, 13, 15Tapered:3.5: 7, 9, 11, 13, 154.0: 7, 9, 11, 13, 155.0: 7, 9, 11, 13, 15	Cylindrical:3.25: 8.5, 10, 11.5, 13, 153.5: 7, 8.5, 10, 11.5, 13, 153.75: 7, 8.5, 10, 11.5, 13, 154.0: 6, 7, 8.5, 10, 11.5, 13, 154.5: 8.5, 10, 11.5, 13, 155.0: 6, 7, 8.5, 10, 11.5, 13, 15	Cylindrical:3.3: 9, 11, 13, 15, 173.75: 9, 11, 13, 15, 17, 194.0: 9, 11, 13, 15, 17, 194.5: 9, 11, 135.0: 7, 9, 11, 13Tapered:3.5: 10, 13, 164.3: 10, 13, 165.0: 10, 13, 16	Cylindrical:3.3: 10, 11.5, 13, 153.75: 8, 10, 11.5, 13, 15, 18, 205.0: 8, 10, 11.5, 13Tapered:4.0: 8, 10, 11.5, 13, 155.0: 8, 10, 11.5, 13	Cylindrical:3.75: 7, 8.5, 10, 11.5, 13, 15, 18,205.0: 6, 7, 8.5, 10, 11.5, 13, 156.0: 7, 8.5, 10, 11.5, 13, 15Tapered:3.25: 8.5, 10, 11.5, 13, 15, 184.0: 6, 8.5, 10, 11.5, 13, 154.7: 10, 11.5, 13, 15, 185.0: 6, 8.5, 10, 11.5, 13, 155.7: 10, 11.5, 13, 15, 18
Sterilization	Provided sterile by irradiation	Provided sterile by irradiation	Provided sterile by irradiation	Provided sterile by irradiation	Provided sterile by irradiation

{10}------------------------------------------------

Page 8 of 22

Table 5.3: SE comparison on HI implants
	SUBJECT DEVICES	PRIMARY PREDICATE DEVICE	REFERENCE DEVICES
Trade NameInformation	K183024 – Implacil Implant System	K170398 - S.I.N. Dental Implant System	K062931 - IMPLUS	K180282 - MIS Internal Hex Dental ImplantSystem
	Implacil de Bortoli Material OdontologicoLtda	S.I.N. Sistema de Implante Nacional S.A.	LEADER Italia S.R.O.	MIS Implants Technologies Ltd.
Implant-to-abutmentconnection	HI interface	HI interface	HI interface	HI interface
Raw Material	CPTi	CPTi	CPTi	Ti alloy (TI-6AI-4V ELI)
Surface	Grit-blasted and acid-etched	Acid-etched and HA	Sand-blasted and acid-etched	Anodized, sand blasted and acid etchedSand blasted and acid etched
Root type design	CylindricalTapered	Cylindrical	CylindricalTapered	CylindricalTapered
Diameter: length (mm)	Cylindrical3.3: 8, 9, 11, 13, 153.75: 7, 9, 11, 13, 154.3: 7, 9, 11, 13, 154.75: 7, 9, 11, 13, 15Tapered:3.5: 8, 9, 11, 13, 154.0: 8, 9, 11, 13, 155.0: 7, 9, 11, 13, 15	Cylindrical3.8: 8.5, 10, 11.5, 13, 154.5: 8.5, 10, 11.5, 13, 155.0: 8.5, 10, 11.5, 13, 15	Cylindrical3.3: 8, 10, 11.5, 13, 163.75: 8, 10, 11.5, 13, 164.5: 8, 10, 11.5, 13, 165.5: 8, 10, 11.5, 13Tapered:4.0: 8, 10, 11.5, 13, 165.0: 8, 10, 11.5, 13, 166.0: 8, 10, 11.5, 13	Cylindrical3.3: 10, 11.5, 13, 163.75: 8, 10, 11.5, 13, 16, 18, 204.2: 6, 8, 10, 11.5, 13, 16, 18, 205.0: 6, 8, 10, 11.5, 13, 166.0: 6, 8, 10, 11.5, 13Tapered:3.3: 10, 11.5, 13, 163.75: 8, 10, 11.5, 13, 16, 18, 204.2: 8, 10, 11.5, 13, 16, 18, 205.0: 8, 10, 11.5, 13, 166.0: 8, 10, 11.5, 13
Sterilization	Provided sterile by irradiation	Provided sterile by irradiation	Provided sterile by irradiation	Provided sterile by irradiation

{11}------------------------------------------------

Page 9 of 22

Table 5.4: SE comparison on CM AR implants
	SUBJECT DEVICES	REFERENCE DEVICES
Trade NameInformation	K183024 – Implacil Implant System	K101945 – Neodent Implant System	K170608 – UF(II) Implant System	K163060 -Deep Conical (DC) Implants andAccessories
	Implacil de Bortoli Material OdontologicoLtda	JJGC Industria e Comercio de MateriaisDentarios S.A.	DIO Corporation	Southern Implants (Pty) Ltd
Implant-to-abutmentconnection	Conical connection (CM AR)	Conical connection (CM)	Conical connection (CM)	Conical connection (Deep Conical)
Raw Material	CPTi	CPTi	CPTi	CPTi
Surface	Grit-blasted and acid-etched	Grit-blasted and acid-etched	Hybrid Sand-blasted and acid-etched	Roughened surface
Root type design	Tapered	CylindricalTapered	Tapered	CylindricalTapered
Implant-to-abutmentindexation feature	Dodecagon (double-hexagon)	Hexagon	Hexagon	Dodecagon (double-hexagon)
Implant diameter: lenghts (mm)	Tapered:3.5: 7, 9, 11, 13, 154.0: 7, 9, 11, 13, 154.5: 7, 9, 11, 13, 155.0: 7, 9, 11, 13, 15	Cylindrical:3.5: 7, 8, 9, 11, 13, 15, 173.75: 7, 8, 9, 11, 13, 15, 174.0: 7, 8, 9, 11, 13, 15, 17, 195.0: 7, 8, 9, 11, 13Tapered:3.5: 8, 10, 11.5, 13, 164.3: 8, 10, 11.5, 13, 165.0: 8, 10, 11.5, 13, 16	Tapered:3.8: 8.5, 10, 11.5, 13, 15, 164.0: 8.5, 10, 11.5, 13, 15, 164.5: 7, 8.5, 10, 11.5, 13, 15, 165.0: 7, 8.5, 10, 11.5, 13, 15, 165.5: 7, 8.5, 10, 11.5, 13, 15, 16	Cylindrical:3.0: 11, 13, 153.5: 8, 9, 11, 13, 154.0: 6, 8, 9, 11, 13, 155.0: 9, 11, 13, 15Tapered:3.0: 9, 11, 13, 153.5: 8, 9, 11, 13, 154.0: 6, 8, 9, 11, 13, 155.0: 9, 11, 13, 15
Sterilization	Provided sterile by irradiation	Provided sterile by irradiation	Provided sterile by irradiation	Provided sterile by irradiation

{12}------------------------------------------------

Page 10 of 22

Table 5.5: SE comparison on Covers
	SUBJECT DEVICES	REFERENCE DEVICES
Trade Name	K183024 - Implacil Implant System	K101207 - Neodent ImplantSystem	K180282 - MIS Internal HexDental Implant System	K101945 – Neodent ImplantSystem	K170608 - UF(II) Implant System
Information	Implacil de Bortoli MaterialOdontologico Ltda	JJGC Industria e Comercio deMateriais Dentarios S.A.	MIS Implants Technologies Ltd.	JJGC Industria e Comercio deMateriais Dentarios S.A.	DIO Corporation
Implant-to-abutment connection(Implant line)	HE interfaceHI interfaceConical interface (CM AR)	HE interface	HI interface	Conical interface (CM)	Conical interface (CM)
Diameter (mm)	HE: 3.5, 4.0, 5.0HI: 3.5, 4.0, 5.0CM AR: 2.5	HE: 3.3, 4.1, 4.3, 5.0	HI: 3.3, 3.75, 4.7	CM: 2.5	CM: 2.7, 2.794, 3.6, 3.8
Gingival Height (mm)	HE: 0HI: 0CM AR: 2	HE: 0	HI: 0	CM: 0, 2	CM: 0, 1, 2, 3
Raw material	CPTi	Ti alloy	Ti alloy	Ti alloy	CPTi
Surface	Machined	Machined	Machined and Anodized	Machined	Machined and anodized
Angulation	0°	0°	0°	0°	0°
Load	No occlusal load	No occlusal load	No occlusal load	No occlusal load	No occlusal load
Sterility	Provided sterile by irradiation.	Provided sterile by ethyleneoxide.	Provided sterile by irradiation	Provided sterile by ethyleneoxide.	Provided sterile by irradiation.

{13}------------------------------------------------

Page 11 of 22

Table 5.6: SE comparison on Healing Abutments
Trade Name Information	SUBJECT DEVICES	PRIMARY PREDICATE DEVICES	REFERENCE DEVICES
	K183024 – Implacil Implant SystemImplacil de Bortoli MaterialOdontologico Ltda	K170398 – S.I.N. Dental Implant SystemS.I.N. Sistema de ImplanteNacional S.A.	K101207 – Neodent Implant SystemJJGC Industria e Comercio deMateriais Dentarios S.A.	K180282 – MIS Internal Hex DentalImplant SystemMIS Implants Technologies Ltd.	K101945 – Neodent Implant SystemJJGC Industria e Comercio deMateriais Dentarios S.A.
Implant-to-abutment connection	HE interfaceHI interfaceConical interface (CM AR)	HE interfaceHI interface	HE interface	HI interface	Conical interface (CM)
Diameter (mm)	HE: 3.5, 4.0, 5.0HI: 3.5, 4.0, 5.0CM AR: 3.5, 4.5	HE: 3.6, 4.1, 5.0	HE: 3.3, 4.1, 4.3, 5.0	HI: 4.0, 4.3, 4.8, 5.0, 5.5, 6.5	CM: 3.5, 4.0
Gingival Height (mm)	HE: 2, 3, 4, 5, 6, 7HI: 2, 3, 4, 5, 6, 7CM AR: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5	HE: 1, 2, 4, 6, 8	HE: 2, 3, 4, 5, 6	HI: 2, 3, 4, 5, 6, 8	CM: 0.8, 3.5, 4.5, 5.5, 6.5
Raw material	CPTi	Ti alloy	Ti alloy	Ti alloy	Ti alloy
Surface	Machined	Machined	Machined	Machined and Anodized	Machined
Angulation	0°	0°	0°	0°	0°
Load	No occlusal load	No occlusal load	No occlusal load	No occlusal load	No occlusal load
Sterility	Provided sterile by irradiation.	Provided sterile by irradiation.	Provided sterile by ethyleneoxide.	Provided sterile by irradiation	Provided sterile by ethyleneoxide.

Table 5.6: SE comparison on Healing Abutments

{14}------------------------------------------------

Table 5.7: SE comparison on Healing Abutment Covers

	SUBJECT DEVICES	PRIMARY PREDICATE DEVICES	REFERENCE DEVICES
Trade NameInformation	K183024 – Implacil Implant SystemImplacil de Bortoli Material OdontologicoLtda	K170398 - S.I.N. Dental Implant SystemS.I.N. Sistema de Implante Nacional S.A.	K180282 – MIS Internal Hex DentalImplant SystemMIS Implants Technologies Ltd.	K170392 - S.I.N. Dental Implant SystemS.I.N. Sistema de Implante Nacional S.A.
Implant-to-abutment connection	Not applicable(is mounted on the abutment)	Not applicable(is mounted on the abutment)	Not applicable(is mounted on the abutment)	Not applicable(is mounted on the abutment)
Diameter (mm)	3.8, 4.5, 4.8	4.8	4.8	3.3
Total height (mm)	5.5, 5.8, 7.5	5	4.3	Unknown
Raw material	CPTi	Ti alloy	CPTi	Ti alloy
Surface	Machined	Machined	Machined	Machined
Angulation	0°	0°	0°	0°
Load	No occlusal load	No occlusal load	No occlusal load	No occlusal load
Sterility	Provided non-sterile. Steam sterilizedprior use.	Provided sterile by irradiation.	Provided sterile by irradiation	Provided sterile by irradiation.

{15}------------------------------------------------

Page 13 of 22

	SUBJECT DEVICES	REFERENCE DEVICE
Trade NameInformation	K183024 - ImplacilImplant System	K101207 – NeodentImplant System	K133510 - NeodentImplant System	K062931 - IMPLUS	K072642 - BIOMET 3iDental Abutmentsand RestorativeComponents	K180282 - MISInternal Hex DentalImplant System	K101945 - NeodentImplant System	K170608 - UF(II)Implant System
	Implacil de BortoliMaterialOdontologico Ltda	JJGC Industria eComercio deMateriais DentariosS.A.	JJGC Industria eComercio deMateriais DentariosS.A.	LEADER Italia S.R.O.	Biomet 3i, Inc.	MIS ImplantsTechnologies Ltd.	JJGC Industria eComercio deMateriais DentariosS.A.	DIO Corporation
Implant-to-abutmentconnection	HE interfaceHI interfaceConical interface(CM AR)	HE interface	HE interface	HE interface	HI interface	HI interface	Conical interface(CM)	Conical interface(CM)
Diameter (mm)	HE: 3.5, 4.0, 5.0HI: 3.5, 4.0, 5.0CM AR: 4.8	HE: 4.1, 4.3, 5.0	HE: 3.3	HE: 4.1	HI: 3.4, 5.0, 6.0	HI: 4.8	CM: 4.8	CM: 4.8
Gingival height (mm)	HE: 1, 2, 3HI: 1, 2, 3CM: 0.8, 1.5, 2.5, 3.5,4.5, 5.5	HE: 1, 2, 3	HE: 1, 2, 3	HE: 1, 2, 3	HI: 1, 2, 3, 4, 5.5	HI: 1, 2, 3, 4, 5	CM: 0.8, 1.5, 2.5,3.5, 4.5, 5.5, 6.5	Unknown
Anti-rotationalfeature	Yes	No	No	No	No	No	No	No
Raw material	CPTi	Ti alloy	Ti alloy	Ti alloy	Ti alloy	Ti alloy	Ti alloy	CPTi
Surface	Machined	Machined	Machined	Machined/TiN	Machined	Machined	Machined	Machined
Angulation	0, 17, 30°	0°	0°	0, 17°	0, 17, 25°	0, 15, 25°	0, 17, 30°	0°
Sterility	Provided non-sterile, to be steamsterilized prior use.	Provided sterile byethylene oxide.	Provided sterile byethylene oxide.	Unknown	Provided sterile.Unknown method	Provided non-sterile, to be steamsterilized prior use.	Provided sterile byethylene oxide.	Provided non-sterile, to be steamsterilized prior use.

{16}------------------------------------------------

Table 5.9: SE comparison on Mini Tapered and Mini Tapered Fit Abutments

	SUBJECT DEVICES			REFERENCE DEVICE
Trade NameInformation	K183024 – Implacil ImplantSystem	K101207 – Neodent ImplantSystem	K180282 – MIS Internal HexDental Implant System	K072642 – BIOMET 3i DentalAbutments and RestorativeComponents	K101945 – Neodent ImplantSystem	K170608 – UF(II) ImplantSystem
	Implacil de Bortoli MaterialOdontologico Ltda	JJGC Industria e Comercio deMateriais Dentarios S.A.	MIS Implants TechnologiesLtd.	Biomet 3i, Inc.	JJGC Industria e Comercio deMateriais Dentarios S.A.	DIO Corporation
Implant-to-abutmentconnection	HE interfaceHI interfaceConical interface (CM AR)	HE interface	HI interface	HI interface	Conical interface (CM)	Conical interface (CM)
Diameter (mm)	HE: 3.5, 4.0, 5.0HI: 3.5, 4.0, 5.0CM AR: 4.8	HE: 4.1, 4.3, 5.0	HI: 4.8	HI: 3.4, 5.0, 6.0	CM: 4.5	CM: 4.8
Gingival height (mm)	HE: 1, 2, 3HI: 1, 2, 3CM AR: 0.8, 1.5, 2.5, 3.5, 4.5, 5.5	HE: 1, 2, 3, 4,	HI: 1, 2, 3	HI: 1, 2, 3, 4, 5.5	CM: 1.5, 2.5, 3.5	Unknown
Anti-rotational feature	Yes	No	No	No	Yes	No
Raw material	CPTiTi alloy	Ti alloy	Ti alloy	Ti alloy	Ti alloy	CPTi
Surface	Machined	Machined	Machined/ Anodized	Machined	Machined	Machined
Angulation	0, 17, 30°	0°	0, 17, 30°	0, 15°	0, 17, 30°	0°
Sterility	Provided non-sterile, to besteam sterilized prior use.	Provided sterile byethylene oxide.	Provided non-sterile, to besteam sterilized prior use.	Provided sterile. Unknownmethod	Provided sterile byethylene oxide.	Provided non-sterile, to besteam sterilized prior use.

{17}------------------------------------------------

Page 15 of 22

Table 5.10: SE comparison on Abutments and Abutment with Collar

	SUBJECT DEVICES	PRIMARY PREDICATEDEVICE	REFERENCE DEVICES
Trade NameInformation	K183024 – Implacil ImplantSystemImplacil de Bortoli MaterialOdontologico Ltda	K170398 – S.I.N. DentalImplant SystemS.I.N. Sistema de ImplanteNacional S.A.	K133510 – Neodent ImplantSystemJJGC Industria e Comercio deMateriais Dentarios S.A.	K180282 – MIS Internal HexDental Implant SystemMIS Implants TechnologiesLtd.	K090452 – Neoss ImplantSystem 03,25Neoss Limited	K140440 – Noris Medical,Ltd.Noris Medical, Ltd.
Implant-to-abutmentconnection	HE interfaceHI interface	HE interfaceHI interface	HE interface	HI interface	HI interface	HI interface
Diameter (mm)	HE: 3.3, 4.0, 5.0HI: 3.3, 4.0, 5.0	HE: 3.6, 4.1, 5.0HI: 3.8, 4.5	HE: 3.3, 4.1, 4.3, 5.0	HI: 3.75, 4.0, 5.5, 6.0, 6.5	HI: 3.25	HI: 3.8, 4.0, 5.4
Gingival height (mm)	HE: 1, 2, 3, 4, 5HI: 1, 2, 3, 4, 5	HE: 1, 2, 3, 4HI: 1, 2, 3, 4	HE:1, 2, 3	HI: 1, 2, 3	HI: 1	HI: 1, 2, 3, 4
Post Height (mm)	9, 10	5, 5.5	4, 6	4, 6	8	9.5, 10.5, 11.5, 12.5
Anti-rotational feature	Yes	No	No	No	Yes	No
Raw material	CPTi	Ti alloy	Ti alloy	Ti alloy	CPTi	Ti alloy
Surface	Machined	Machined/ Anodized	Machined	Machined/Anodized	Machined	Machined
Angulation	0, 15, 25°	0°	0, 17, 30°	0, 10, 15, 20, 25°	0, 20°	0, 15, 25°
Sterility	Provided non-sterile, tobe steam sterilized prioruse.	Provided sterile forirradiation.	Provided sterile byethylene oxide.	Provided non-sterile, to besteam sterilized prior use.	Provided sterile byirradiation	Provided non-sterile, to besteam sterilized prior use.

{18}------------------------------------------------

Table 5.11: SE comparison on Smart and Ideale abutment

Trade Name Information	SUBJECT DEVICES	REFERENCE DEVICES
	K183024 – Implacil Implant System	K101945 – Neodent Implant System
	Implacil de Bortoli Material Odontologico Ltda	JJGC Industria e Comercio de Materiais Dentarios S.A.
Implant-to-abutment connection	Conical interface	Conical interface
Diameter (mm)	3.3, 4.5	3.3, 4.5
Gingival height (mm)	0.8, 1.5, 2.5, 3.5, 4.5, 5.5	0.8, 1.5, 2.5, 3.5, 4.5, 5.5
Cementable Height	4, 6	4, 6
Anti -rotational feature	Yes	Yes
Raw material	CPTiTi alloy	Ti alloy
Surface	Machined/Anodized	Machined
Angulation	0°, 17°, 30°	0°, 17°, 30°
Sterility	Provided non-sterile, to be steam sterilized prior use.	Provided sterile by ethylene oxide.

{19}------------------------------------------------

Page 17 of 22

Table 5.12: SE comparison on O'ring Abutment

	SUBJECT DEVICES	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
	K183024 - Implacil Implant	K170398 - S.I.N. Dental	K101207 - Neodent Implant	K180282 - MIS Internal Hex	K101945 - Neodent Implant	K173819 - MyPlant II
Trade NameInformation	System	Implant System	System	Dental Implant System	System	Implant System
	Implacil de Bortoli Material	S.I.N. Sistema de Implante	JJGC Industria e Comercio de	MIS Implants Technologies	JJGC Industria e Comercio de	Hager & Meisinger GmbH
	Odontologico Ltda	Nacional S.A.	Materiais Dentarios S.A.	Ltd.	Materiais Dentarios S.A.
Implant-to-abutmentconnection	HE interface	HE interface	HE interface
	HI interface	HI interface		HI interface
	Conical interface (CM AR)				Conical interface (CM)	Conical interface (CM)
Diameter (mm)	HE: 3.5, 4.0, 5.0	HE: 3.4, 4.1, 5.0	HE: 4.1, 4.3, 5.0
	HI: 3.5, 4.0, 5.0	HI: 3.8, 4.5		HI: 4.0, 5.0
	CM AR: 4.0				CM: 3.5	Snap Attachment Sphere:
						2.25
Height (mm)	HE: 1, 2, 3, 4, 5	HE: 2, 3	HE: 2, 3, 4, 5
	HI: 1, 2, 3, 4, 5	HI: 2, 3		HI: 1, 2, 3, 4, 5
	CM AR: 0.8, 1.5, 2.5, 3.5,				CM: 1.5, 2.5, 3.5, 4.5, 5.5	CM: 1.5, 3.0, 4.5
	4.5, 5.5
Anti-rotational feature	No	No	No	No	No	No
Raw material	CPTi	Ti alloy	Ti alloy	Ti alloy	Ti alloy	CPTi
Surface	Machined	Machined	Machined	Machined	Machined	Machined
				Machined/TiN
Angulation	0°	0°	0°	0, 15, 25°	0°	0°
Sterility	Provided non-sterile, to be	Unknown	Provided sterile by	Provided non-sterile, to be	Provided sterile by	Provided non-sterile, to be
	steam sterilized prior use.		ethylene oxide.	steam sterilized prior use.	ethylene oxide.	steam sterilized prior use.

{20}------------------------------------------------

Table 5.13: SE comparison on UCLA abutments

	SUBJECT DEVICES	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
Trade NameInformation	K183024 – Implacil Implant System	K170398 – S.I.N. Dental Implant System	K101207 – Neodent Implant System	K180282 – MIS Internal Hex DentalImplant System	K173902 – Neodent ImplantSystem – GM Line
	Implacil de Bortoli MaterialOdontologico Ltda	S.I.N. Sistema de ImplanteNacional S.A.	JJGC Industria e Comercio deMateriais Dentarios S.A.	MIS Implants Technologies Ltd.	JJGC Industria e Comercio deMateriais Dentarios S.A.
Implant-to-abutmentconnection	HE interfaceHI interfaceConical interface	HE interfaceHI interface	HE interface	HI interface	Conical interface
Diameter (mm)	3.5, 4.0, 5.0	3.6, 4.1	4.1, 4.3, 5.0	3.75, 5.0	3.5/3.75, 4.0/4.3, 5.0/6.0
Gingival Height (mm)	Not applicable	Not applicable	Not applicable	Not applicable	Not applicable
Anti-rotational feature	Yes	Yes	Yes	Yes	Yes
Raw material	CPTiCoCr/POM	Ti alloyCoCr/POM	Ti alloyNoble/POMZirconia	Gold/POM	CoCr/POM
Surface	Machined	Machined	Machined	Machined	Machined
Angulation	0°	0°	0°	0°	0°
Sterility	Provided non-sterile, to besteam sterilized prior use.	Unknown	Provided sterile by ethyleneoxide.	Provided non-sterile, to be steamsterilized prior use.	Provided non-sterile, to be steamsterilized prior use.

{21}------------------------------------------------

Page 19 of 22

Table 5.14: SE comparison on Copings

	SUBJECT DEVICES	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
Trade NameInformation	K183024 – Implacil Implant System	K170398 – S.I.N. Dental ImplantSystem	K101207 – Neodent ImplantSystem	K101945 - Neodent ImplantSystem	K170608 - UF(II) Implant System
	Implacil de Bortoli MaterialOdontologico Ltda	S.I.N. Sistema de Implante NacionalS.A.	JJGC Industria e Comercio deMateriais Dentarios S.A.	JJGC Industria e Comercio deMateriais Dentarios S.A.	DIO Corporation
Implant-to-abutment	Not applicable	Not applicable	Not applicable	Not applicable	Not applicable
connection	(is mounted on the abutment)	(is mounted on the abutment)	(is mounted on the abutments)	(is mounted on the abutments)	(is mounted on the abutments)
Diameter (mm)	3.3, 3.5, 4.0, 4.5, 4.8, 5.0	3.8, 4.5	4.1, 5.0	3.3, 4.1, 4.5	4.95, 5.8, 6.4, 6.9
Gingival Height (mm	Not applicable	Not applicable	Not applicable	Not applicable	Not applicable
Cementable height (mm)	4, 6	Unknown	Unknown	4, 6	Unknown
Anti-rotational feature	Yes	Yes	Yes	Yes	No
Raw material	CPTiCoCr/POM	Ti alloyCoCr/POM	Ti alloyNoble/POMZirconia	Ti alloyNoble/POMPOM	CPTi
Surface	Machined	Machined	Machined	Machined	Machined
Angulation	0°	0°	0°	0°	0°
Sterility	Provided non-sterile, to be steamsterilized prior use.	Not informed	Provided sterile by ethyleneoxide.	Provided sterile by ethyleneoxide.	Provided non-sterile, to besteam sterilized prior use.

{22}------------------------------------------------

Page 20 of 22

Table 5.15: SE comparison on Screws
	SUBJECT DEVICES	PRIMARY PREDICATE DEVICE	REFERENCE DEVICE
	K183024 – Implacil Implant System	K170398 – S.I.N. Dental Implant System	K101207 – Neodent Implant System	K101945 – Neodent Implant System
Trade NameInformation	Implacil de Bortoli Material OdontologicoLtda	S.I.N. Sistema de Implante Nacional S.A.	JJGC Industria e Comercio de MateriaisDentarios S.A.	JJGC Industria e Comercio de MateriaisDentarios S.A.
Implant-to-abutment connection	HE interfaceHI interfaceConical interface	HE interfaceHI interface	HE interface	Conical interface
Implant/Abutment diameter (mm)	3.5, 4.0	Unknown	3.3, 4.1, 4.3, 5.0	4.1, 5.0
Implant/Abutment gingival height(mm)	2, 3	Unknown	1, 2, 3	Unknown
Cementable height (mm)	Not applicable	Not applicable	Not applicable	Not applicable
Anti-rotational feature	Not applicable	Not applicable	Not applicable	Not applicable
Raw material	Ti alloy	Ti alloy	Ti alloy	Ti alloy
Surface	Machined	MachinedMachined/ Anodized	Machined	Machined
Angulation	0°	0°	0°	0°
Sterility	Provided non-sterile, to be steamsterilized prior use.	Unknown	Provided sterile by ethylene oxide.	Provided sterile by ethylene oxide.

{23}------------------------------------------------

The indication for use of subject and primary predicate device K170398 are identical except for two slight changes.

1. Inclusion of "and/" in order that the indication for use statement is applicable to all the subject devices instructions for use and not misleading in any way. Currently, the subject devices are divided in 16 instructions for use. For example, many of the subject abutment are indicated for both, single-unit and also multi-unit restorations. The proposed inclusion brings clarity to the cases where both indications are recommended and is also applicable for cases where just one of them is indicated.

2. The current submission do not have subject implants with length below 7 mm, therefore, the last sentence of the primary predicate instructions for use is not applicable.

The indication for use of subject device is within the scope of the reference devices indications for use.

The subject HE Implants are substantially equivalent to the primary predicate device K170398, and reference devices K101207, K062931 and K163634, in designs and range of dimensions. The subject HI Implants are substantially equivalent to the primary predicate device K170398, and reference devices K062931 and K180282, in designs and range of dimensions. The subject CM AR Implants are substantially equivalent to the reference devices K101945, K170608 and K163060, in designs and range of dimensions.

The subject Covers are substantially equivalent to the reference devices K101207, K180282, K101945 and K170608, in designs and range of dimensions. The subject Healing Abutments are substantially equivalent to the primary predicate K170398 and to the reference devices K101207, K180282 and K101945, in designs and range of dimensions. The subject Healing Abutment Covers are substantially equivalent to the primary predicate K170398 and to the reference devices K180282 and K170392, in designs and range of dimensions.

The subject Tapered Aesthetic Abutments are substantially equivalent to the reference devices K101207, K133510, K062931, K072642, K101945 and K170608, in designs and range of dimensions. The subject Mini Tapered and Mini Tapered Fit Abutments are substantially equivalent to the reference devices K101207, K180282, K072642, K101945 and K170608, in designs and range of dimensions. The subject Abutments are substantially equivalent to the primary predicate device K170398, and reference devices K133510, K180282, K090452 and K140440, in designs and range of dimensions. The subject Smart and Ideale Abutments are substantially equivalent to the reference device K101945, in designs and range of dimensions.

The subject O'ring Abutment is substantially equivalent to the primary predicate device K170398, and reference devices K101207, K180282, K101945 and K173819, in designs and range of dimensions. The reference device K101207 is for the HE connection in the heights not encompassed by the primary predicate device.

The subject UCLA abutment are substantially equivalent to the primary predicate device K170398, and reference devices K101207, K180282 and K173902 in raw material, designs and range of dimensions. The subject Copings are substantially equivalent to the primary predicate device K170398, and reference devices K101207, K101945 and K170608 in raw material, designs and range of dimensions.

The subject Screws are substantially equivalent to the primary predicate device K170398, and reference devices K101207 and K101945 in raw material, designs and range of dimensions.

{24}------------------------------------------------

PERFORMANCE DATA

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included:

Sterilization validation according to ISO 11137-1, ISO 17665-1, ISO 17665-2. Sterile barrier shelf life testing (accelerated aging according to ASTM F1980); package integrity according to ASTM F1929 and ASTM F88/F88M; sterility of the package content according to ISO 11737-2. The biocompatibility of the subject devices materials was supported by cytotoxicity testing according to ISO 10993-12. Pyrogenicity monitoring according to AAMI/ANSI ST72. Mechanical performance demonstrated through dynamic fatigue testing according to ISO 14801 and static torsional loading test according ISO/TS 13498:2011. 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.