ALFA GATE® Dental Implants System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. ALFA GATE® Dental Implants System may be immediate loading when good primary stability is achieved and with appropriate occlusal loading. ALFA GATE® 3.00mm S-LINE & SLIM implants are intended for placement at the mandibular central and lateral incisors and maxillary lateral incisors. Indicated also for denture stabilization using multiple implants. Two Stage Implants: M+, S-LINE, SCI, SCIP, MAX. One Stage Implants: SLIM Implants.

ALFA GATE Dental Implants longer than 13mm are to be used with straight abutments only.

Device Description

ALFA GATE® Dental Implant System is consist of endosseous form Dental Implants, Internal hex Implants, Internal Conical Connection Implants, One piece Implants, tapered design; cover screws, healing caps and abutment systems; Dental Implants are provided in two options of surface treatment (1) Bioactive Surface-CaP which is a calcium phosphate coating; or (2) Sand blast large particles with acid etched;

Dental Implants:

M+ IMPLANTS - Internal Hex, Conical Connection Implant

Measurements: Diameter mm 3.5, 4.3, 5.0, 6.0; with Length mm 8, 10, 11.5, 13, 16(not for 60 mm);

S-LINE Implants - Internal Hex implant, Narrow Implants

BIOACTIVE S-LINE Implant - Measurements: Diameter mm 3.0 with Length mm 10, 11.5, 13;

POROUS S-LINE Implant - Measurements: Diameter mm 3.0 with Length mm 10, 11.5, 13:

SCI Implants - Internal Hex implant, Spiral conical design

BIOACTIVE SCI Implant - Measurements: Diameter mm 3.3, 3.75, 4.2, 4.7, 5.2, 6.0 with Length mm 8, 10, 11.5, 13, 16 (not for 5.20,60 mm);

POROUS SCIP Implant - Measurements: Diameter mm 3.3, 3.75, 4.2, 4.7, 5.2, 6.0 with Length mm 8, 10, 11.5, 13, 16 (not for 5.2Ø,6Ø mm):

MAX Implant - Internal hex implant, cylindrical and conical body design

Measurements: Diameter mm 3.3, 3.75, 4.2, 4.7, 5.2 with Length mm 8, 10, 11.5, 13, 16;

SLIM Implant - One Piece implants

Measurements: Diameter mm 3.0, 3.3, 3.75 with Length mm 10, 11.5, 13, 15;

Dental Abutments:

Straight abutments (Regular, Thin, Wide, Narrow), Angled Abutments 15° (Regular, Short), Multi Unit, Shoulder abutments, Esthetic Abutments, Concave Esthetic Abutments, Esthetic Abutments 15°, Concave Angulated Abutments 15°, Esthetic Abutments , Alfa lock abutment (locator), Ball attachment Abutment, Ball attachment concave, Healing Caps (Narrow, Regular, Wide, Slim), Concave healing caps, Anatomic Abutment. Angled abutments are only to be used with S-Line, SCI, and MAX implants. M+ and SLIM implants are not to be used with angled abutments. Dental Abutments Conical Connection:

Anatomic straight Abutment (RP, NP), Standard straight abutment (RP, NP), Ball attachment (RP, NP), Healing Caps (RP, NP).

AI/ML Overview

The provided text describes the 510(k) premarket notification for the ALFA GATE® Dental Implants System. The entire document focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on proving device performance against specific acceptance criteria for an AI/ML-based device.

Therefore, I cannot provide the requested information as the provided text does not contain:

Acceptance criteria for an AI/ML device: The document pertains to traditional dental implants and abutments.
Reported device performance for an AI/ML device: The performance tests conducted are for mechanical, biocompatibility, and sterilization properties of the physical implants, not for an AI/ML algorithm's diagnostic or predictive capabilities.
Sample size or data provenance for AI/ML test sets: There are no mentions of test sets, training sets, or data used for AI/ML model evaluation.
Information about experts or ground truth for AI/ML evaluation: The document does not discuss expert adjudication or establishing ground truth for evaluating AI/ML performance.
MRMC studies or standalone AI performance: These are concepts specific to AI/ML device studies, which are not relevant to the content of this document.

The document primarily relies on bench testing (fatigue, sterilization, shelf-life, biocompatibility, surface tests) and comparison to predicates to demonstrate substantial equivalence for the physical dental implant system. There is no mention of any AI or machine learning component in the ALFA GATE® Dental Implants System.

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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 3, 2019

Alfa Gate Mazen Ltd % Daniela Levy Regulatory Consultant Sterling Medical Registration 22815 Ventura Blvd Woodland Hills, California 91364

Re: K182143

Trade/Device Name: ALFA GATE® Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 9, 2019 Received: July 9, 2019

Dear Daniela Levy:

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

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

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

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

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

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

Sincerely,

for Srinivas Nandkumar, Ph.D. Acting 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}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for AlfaGate Dental Implants Experts. The logo consists of a circular icon with a gradient of colors from yellow to green on the left, followed by the text "AlfaGate" in a dark blue, sans-serif font. Below the name, the words "DENTAL IMPLANTS EXPERTS" are written in a smaller, lighter font.

Page 1 of

SECTION 4 -

Indication for Use Statement

510(k) Number (if known): K182143 Device Name: ALFA GATE® Dental Implants System Indications for Use (Describe)

Indications for Use:

ALFA GATE Dental Implants longer than 13mm are to be used with straight abutments only.

Type of Use (Select one or both, as applicable)

凶 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use(21 CFR 801 Subpart

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for AlfaGate Dental Implants Experts. The logo consists of a colorful hexagon-shaped icon on the left and the company name "AlfaGate" in a bold, dark blue font on the right. Below the company name, the words "DENTAL IMPLANTS EXPERTS" are written in a smaller, lighter font.

SECTION 5 -

510(k) Number K182143

1	Type of Submission Premarket Notification (21 CFR 807.90(e)) 510(k) Traditional
2	Submission Owner	ALFA GATE MAZEN LTD.
		Dr. Mohamad Zahalka - CEO
		Hitin st.2, P.O.BOX 301
		Kfar Qara 3007500, Israel
		Tel	: +972-4-6356686
		Fax	: +972-4-6354466
3	Official CorrespondentContact Person	Sterling Medical RegistrationDaniela Levy - Regulatory Consultant22815 Ventura blvd.Woodland Hills, CA 91364Phone: 1-213-787-3027Email: sterlingmedical2017@gmail.com;daniela@sterlingmedicalregistration.com
4	Date Prepared	October 3rd, 2019
5	Device Trade Name	ALFA GATE® Dental Implants System
6	Regulation Description	Endosseous Dental Implants
7	Classification	Product Code	: DZE
		Device Name	: Implant, endosseous, root-form
		Regulation No	: 872.3640
		Class	: II
		Panel	: Dental
		Secondary Product Code	: NHA
8	Reason for the Premarket Notification Submission	: New Device

9 Identification of Legally Marketed Predicate Devices : Primary Predicate:
SGS International Itd - SGS Dental Implants System K182219;

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

Image /page/4/Picture/0 description: The image shows the logo for AlfaGate Dental Implants Experts. The logo consists of a circular design on the left, made up of three curved shapes in different colors: orange, yellow, green, and blue. To the right of the circular design is the text "AlfaGate" in a dark blue, sans-serif font. Below "AlfaGate" is the text "DENTAL IMPLANTS EXPERTS" in a smaller, sans-serif font.

Reference Devices:

SGS International Itd - SGS Dental Implants System K133362;

10 Device Description:
ALFA GATE® Dental Implant System is consist of endosseous form Dental Implants, Internal hex Implants, Internal Conical Connection Implants, One piece Implants, tapered design; cover screws, healing caps and abutment systems; Dental Implants are provided in two options of surface treatment (1) Bioactive Surface-CaP which is a calcium phosphate coating; or (2) Sand blast large particles with acid etched;

Dental Implants:

M+ IMPLANTS - Internal Hex, Conical Connection Implant

Measurements: Diameter mm 3.5, 4.3, 5.0, 6.0; with Length mm 8, 10, 11.5, 13, 16(not for 60 mm);

S-LINE Implants - Internal Hex implant, Narrow Implants

BIOACTIVE S-LINE Implant - Measurements: Diameter mm 3.0 with Length mm 10, 11.5, 13;

POROUS S-LINE Implant - Measurements: Diameter mm 3.0 with Length mm 10, 11.5, 13:

SCI Implants - Internal Hex implant, Spiral conical design

BIOACTIVE SCI Implant - Measurements: Diameter mm 3.3, 3.75, 4.2, 4.7, 5.2, 6.0 with Length mm 8, 10, 11.5, 13, 16 (not for 5.20,60 mm);

POROUS SCIP Implant - Measurements: Diameter mm 3.3, 3.75, 4.2, 4.7, 5.2, 6.0 with Length mm 8, 10, 11.5, 13, 16 (not for 5.2Ø,6Ø mm):

MAX Implant - Internal hex implant, cylindrical and conical body design

Measurements: Diameter mm 3.3, 3.75, 4.2, 4.7, 5.2 with Length mm 8, 10, 11.5, 13, 16;

SLIM Implant - One Piece implants

Measurements: Diameter mm 3.0, 3.3, 3.75 with Length mm 10, 11.5, 13, 15;

Dental Abutments:

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

Image /page/5/Picture/0 description: The image is a logo for AlfaGate Dental Implants Experts. The logo features a colorful, circular icon on the left, made up of six segments in different colors: blue, green, yellow, and orange. To the right of the icon is the company name, "AlfaGate," in a bold, dark blue font. Below the name, in smaller letters, is the tagline "DENTAL IMPLANTS EXPERTS."

concave, Healing Caps (Narrow, Regular, Wide, Slim), Concave healing caps, Anatomic Abutment. Angled abutments are only to be used with S-Line, SCI, and MAX implants. M+ and SLIM implants are not to be used with angled abutments. Dental Abutments Conical Connection:

Anatomic straight Abutment (RP, NP), Standard straight abutment (RP, NP), Ball attachment (RP, NP), Healing Caps (RP, NP).

11 Indication for Use
ALFA GATE® Dental Implants System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. ALFA GATE® Dental Implants System may be immediate loading when good primary stability is achieved and with appropriate occlusal loading. ALFA GATE® 3.0Ømm S-LINE & SLIM implants are intended for placement at the mandibular central and lateral incisors and maxillary lateral incisors. Indicated also for denture stabilization using multiple implants. Two Stage Implants: M+, S-LINE, SCI, SCIP, MAX. One Stage Implants: SLIM Implants.

ALFA GATE Dental Implants longer than 13mm are to be used with straight abutments only.

12 Performance Standards or Guidance Documents
- . ISO 7405 Second edition 2008-12-15 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.
- ISO 5832-3:1996 Implants for surgery -- Metallic materials -- Part 3: Wrought . titanium 6-aluminium 4-vanadium alloy.
- ISO 14801 Second edition 2007-11-15 Dentistry-Implants-Dynamic fatique test for . endosseous dental implants.
- ISO 11137-1:2006 Sterilization of health care products -- Radiation -- Part 1: . Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 11737-2: 2009 Sterilization of medical devices -- Microbiological methods --. Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- ASTM F-1980 16 Standard Guide for Accelerated Aging of Sterile Barrier Systems . for Medical Devices

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

Image /page/6/Picture/0 description: The image contains the logo for AlfaGate Dental Implants Experts. The logo consists of a circular icon on the left and the company name on the right. The circular icon is made up of six segments, each with a different color: blue, teal, green, yellow, orange, and light blue. The company name is written in a dark blue sans-serif font, with the words "DENTAL IMPLANTS EXPERTS" written in a smaller font below.

ISO 17665-1:2006 Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 17665-2:2009 Sterilization of health care products -- Moist heat -- Part 2: . Guidance on the application of ISO 17665-1
. ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in . vitro cytotoxicity
. FDA guidance document: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff.
Chemical and SEM analysis performed on implants per Class II Special Controls . Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff.
Endotoxin batch testing protocol per FDA Guidance Document Submission and . Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
Reprocessing Medical Devices in Health Care Settings: Validation Methods and . Labeling Guidance for Industry and Food and Drug Administration Staff.
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices . - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff

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

Image /page/7/Picture/0 description: The image is a logo for AlfaGate. The logo consists of a hexagon made of six different colored sections on the left, and the text "AlfaGate" in a dark blue font on the right. Below the text "AlfaGate" is the text "DENTAL IMPLANTS EXPERTS" in a smaller, lighter blue font.

13 Substantial Equivalence

SE Table - Indication for Use:

	Candidate	Primary Predicate	Reference Device
	ALFA GATE	SGS International	SGS International
K Number	K182143	K182219	K133362
Indication for use	ALFA GATE® Dental ImplantsSystem is intended for surgicalplacement in the maxillaryand/or mandibular arch tosupport crowns, bridges, oroverdentures in edentulous orpartially edentulous patients.ALFA GATE® Dental ImplantsSystem may be immediateloading when good primarystability is achieved and withappropriate occlusal loading.ALFA GATE® 3.00mm S-LINE &SLIM implants are intended forplacement at the mandibularcentral and lateral incisors andmaxillary lateral incisors.Indicated also for denturestabilization using multipleimplants. Two Stage Implants:M+, S-LINE, SCI, SCIP, MAX. OneStage Implants: SLIM Implants.ALFA GATE Dental Implantslonger than 13mm are to beused with straight abutmentsonly.	SGS® Dental Implants System isintended for surgical placementin the maxillary and/ormandibular arch to supportcrowns, bridges, or overdenturesin edentulous or partiallyedentulous patients. SGS® DentalImplants System may beimmediate loading when goodprimary stability is achieved andwith appropriate occlusal loading.Narrow diameter implants (3.2)are intended for maxillary lateralincisors and mandibular lateraland central incisors.Two Stage Implants: P7N, P1D,P5D, P7D. PEEK TemporaryAbutments are not to exceed 30days.	SGS® Dental Implants System isintended for surgical placementin the maxillary and/ormandibular arch to supportcrowns, bridges, or overdenturesin edentulous or partiallyedentulous patients. SGS® DentalImplants System may beimmediate loading when goodprimary stability is achieved andwith appropriate occlusal loading.Two Stage Implants: P1, P7, P7N.One Stage: P7S, P9S.One Stage & One-Piece 3.0 mmdiameter implants: P7S, P9S areintended for placement at themandibular central and lateralincisors and maxillary and lateralincisors. Indicated also fordenture stabilization usingmultiple implants.One stage & One-Piece 2.4 mmdiameter implants for temporaryuse or long term use:P9S permit immediate splintstability and long term fixation ofnew or existing crown, bridge andprosthesis, and protection ofgraft sites.PEEK Temporary Abutments arenot to exceed 30 days.

SE - Indication for Use Discussion -

The candidate ALFA GATE SLIM share the same indication for use as its primary predicate SGS K182219 and reference device SGS K133362. Minor differences are that SGS K133362 introduces smaller onepiece implants and narrow implants with 2.4ø, where ALFA GATE introduces the SLIM onepiece implants and S-LINE narrow implants with 3.0ø. However still sharing the same indication and therefore, ALFA GATE can be considered to be substantially equivalent to its reference device.

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

Image /page/8/Picture/0 description: The image shows the logo for AlfaGate Dental Implants Experts. The logo consists of a hexagonal shape made up of six curved segments, each in a different color: blue, light blue, green, light green, yellow, and orange. To the right of the shape is the text "AlfaGate" in a dark blue, sans-serif font, with the words "DENTAL IMPLANTS EXPERTS" in a smaller font below.

SE - Dental Implan

Characteristic	CandidateM+ Implants(Cat# SCA)	Primary PredicateP7D - Dental Implant with DoubleConnection
510(k) number	K182143	K182219
Manufacturer	Alfa Gate Mazen Ltd	SGS International Itd
Product Name	M+ Implants	P7D - Dental Implant with DoubleConnection
Thread Design	Tapered, Double Thread	Tapered, Double Thread
Measurementsmm	3.5 Ø: 8 ,10, 11.5, 13, 164.3 Ø: 8 ,10, 11.5, 13, 165.0 Ø: 8 ,10, 11.5, 13, 166.0 Ø: 8 ,10, 11.5, 13	3.5 Ø: 8, 10, 11.5, 13, 163.75 Ø: 8, 10, 11.5, 13, 164.2 Ø: 8, 10, 11.5, 13, 164.5 Ø: 8, 10, 11.5, 13, 165.0 Ø: 8, 10, 11.5, 13, 166.0 Ø: 8, 10, 11.5, 13, 16
ConnectionType	Internal hex conical connection, coneangulation 23.5°	Internal hex conical connection , coneangulation 18°
Material	Ti 6Al-4V ELI	Ti 6Al-4V ELI
SurfaceTreatment	Sand Blast and acid-etched	Calcium Phosphate Coating
Self tapping	✓	✓
Sterilization	Gamma Ray	Gamma Ray
Packaging	Double packaging	Double packaging

SE Discussion

Technical Parameters comparison:

The candidate ALFA GATE M+ Implants share the same implant design, raw materials and implants' measurements as its primary predicate SGS K182219. The differences are related to the cone angulation, diameter and surface treatment. ALFA GATE cone angulation is 23.5°, Primary Predicate SGS cone angulation is 18°. This is considered to be minor difference as verified by Fatigue Test results. ALFA GATE introduces 4.3ø where the primary predicate SGS K182219 introduces 4.2ø however this is considered to be minor differences as this is covered by the range of the primary predicate SGS K182219. The implant surface is Sand Blasted and acid-etched, which is demonstrated as substantially equivalent per recommendations of the FDA Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Therefore ALFA GATE M+ Implants can be considered substantially equivalent to its primary predicate SGS K182219.

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

Image /page/9/Picture/0 description: The image shows the logo for AlfaGate Dental Implants Experts. The logo consists of a colorful, circular graphic to the left of the company name, which is written in a dark blue, stylized font. Below the company name, the words "DENTAL IMPLANTS EXPERTS" are written in a smaller, sans-serif font.

Characteristic	CandidateBIOACTIVE S-LINEImplant (Cat# S-LINE)	CandidatePOROUS S-LINEImplant (Cat# S-LINE)	Reference DeviceSGS P7N Narrow Conical Implant
510(k)number	K182143	K182143	K133362
Manufacturer	Alfa Gate Mazen Ltd	Alfa Gate Mazen Ltd	SGS International Ltd
Product Name	BIOACTIVE S-LINEImplant	POROUS S-LINEImplant	P7N Narrow Conical Implant
Thread Design	Tapered, DoubleThread	Tapered, DoubleThread	Tapered, Double Thread
Measurementsmm	3.0 Ø: 10, 11.5, 13	3.0 Ø: 10, 11.5, 13	3.0 Ø: 10, 11.5, 13, 163.2 Ø: 10, 11.5, 13, 16
Connection	Internal Hex	Internal Hex	Internal Hex
Material	Ti 6Al-4V ELI	Ti 6Al-4V ELI	Ti 6Al-4V ELI
SurfaceTreatment	Calcium PhosphateCoating	Sandblasted andacid etched	Calcium Phosphate Coating
Self tapping	✓	✓	✓
Sterilization	Gamma Ray	Gamma Ray	Gamma Ray
Packaging	Double packaging	Double packaging	Double packaging

Technical Parameters comparison:

The candidate ALFA GATE BIOACTIVE S-LINE & POROUS S-LINE Implants share the same implant design, raw materials and implants' measurements as its reference device SGS K133362. Minor difference is related to implant surface, ALFA GATE BIOACTIVE S-LINE Implant is provided with surface treatment of Calcium Phosphate & HA as in similar to its reference device. Where the ALFA GATE POROUS S-LINE is provided with surface treatment of Sand Blast and acid etched, which is demonstrated as substantially equivalent per recommendations of the FDA Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Therefore, ALFA GATE BIOACTIVE S-LINE & POROUS S-LINE Implants can be considered substantially equivalent to its reference device SGS K133362.

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

Image /page/10/Picture/0 description: The image shows the logo for AlfaGate, a dental implant company. The logo consists of a colorful, hexagonal shape on the left, followed by the company name in a dark blue, sans-serif font. Below the company name, the words "DENTAL IMPLANTS EXPERTS" are written in a smaller, sans-serif font.

Characteristic	CandidateBIOACTIVE SCI Implant(Cat# SCI)	CandidatePOROUS SCIP Implant(Cat# SCIP)	Reference DeviceSGS P1 Screw Type GroovyImplant
510(k)number	K182143	K182143	K133362
Manufacturer	Alfa Gate Mazen Ltd	Alfa Gate Mazen Ltd	SGS International Ltd
Product Name	BIOACTIVE SCI Implant	POROUS SCIP Implant	P1 Screw Type Groovy Implant
Thread Design	Tapered, Double Thread	Tapered, Double	Tapered, Double Thread
Measurements mm	3.3 Ø: 8, 10, 11.5, 13, 16	3.3 Ø: 8, 10, 11.5, 13, 16	3.2 Ø: 8, 10, 11.5, 13, 16
	3.75 Ø: 8, 10, 11.5, 13, 16	3.75 Ø: 8, 10, 11.5, 13, 16	3.75 Ø: 8, 10, 11.5, 13, 16
	4.2 Ø: 8, 10, 11.5, 13, 16	4.2 Ø: 8, 10, 11.5, 13, 16	4.2 Ø: 8, 10, 11.5, 13, 16
	4.7 Ø: 8, 10, 11.5, 13, 16	4.7 Ø: 8, 10, 11.5, 13, 16	4.5 Ø: 8, 10, 11.5, 13, 16
	5.2 Ø: 8, 10, 11.5, 13	5.2 Ø: 8, 10, 11.5, 13	5.0 Ø: 8.,10, 11.5, 13, 16
	6.0 Ø: 8, 10, 11.5, 13	6.0 Ø: 8, 10, 11.5, 13	6.0 Ø:8, 10, 11.5, 13, 16
Connection	Internal Hex	Internal Hex	Internal Hex
Material	Ti 6Al-4V ELI	Ti 6Al-4V ELI	Ti 6Al-4V ELI
Surface	Calcium PhosphateCoating	Sandblasted and acidetched	Calcium Phosphate Coating
Surface Treatment	Coating	etched
Self tapping	✓	✓	✓
Sterilization	Gamma Ray	Gamma Ray	Gamma Ray
Packaging	Double packaging	Double packaging	Double packaging

Technical Parameters comparison:

The candidate ALFA GATE BIOACTIVE SCI & POROUS SCIP Implants share the same implant design, raw materials and implants' measurements as its reference device SGS K133362. Minor difference is related to implant surface, ALFA GATE BIOACTIVE SCI Implant is provided with surface treatment of Calcium Phosphate & HA as in similar to its reference device. Where the ALFA GATE POROUS SCIP is provided with surface treatment of Sand Blast and acid etched, which is demonstrated as substantially equivalent per recommendations of the FDA Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Therefore, ALFA GATE BIOACTIVE SCI & POROUS SCIP Implants can be considered substantially equivalent to its reference device SGS K133362.

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

Image /page/11/Picture/0 description: The image shows the logo for AlfaGate Dental Implants Experts. The logo consists of a circular design with six sections, each in a different color: blue, green, yellow, and orange. To the right of the circular design is the text "AlfaGate" in a dark blue, sans-serif font. Below "AlfaGate" is the text "DENTAL IMPLANTS EXPERTS" in a smaller, sans-serif font.

Characteristic	CandidateMAX Dental Implants(Cat# MAX)	Reference DeviceSGS P1 Screw Type Groovy Implant
510(k) number	K182143	K133362
Manufacturer	Alfa Gate Mazen Ltd	SGS International Ltd
Product Name	MAX Implants	P1 Screw Type Groovy Implant
Thread Design	Tapered, Double Thread	Tapered, Double Thread
Measurementsmm	3.3 Ø: 8, 10, 11.5, 13, 163.75 Ø: 8, 10, 11.5, 13, 164.2 Ø: 8, 10, 11.5, 13, 164.7 Ø: 8, 10, 11.5, 13, 165.2 Ø: 8, 10, 11.5, 13	3.2 Ø: 8, 10, 11.5, 13, 163.75 Ø: 8, 10, 11.5, 13, 164.2 Ø: 8, 10, 11.5, 13, 164.5 Ø: 8, 10, 11.5, 13, 165.0 Ø: 8, 10, 11.5, 13, 166.0 Ø: 8, 10, 11.5, 13, 16
Connection	Internal hex	Internal Hex
Material	Ti 6Al-4V ELI	Ti 6Al-4V ELI
Surface	Sand Blast and acid-etched	Calcium Phosphate Coating
Self tapping	✓	✓
Sterilization	Gamma Ray	Gamma Ray
Packaging	Double packaging	Double packaging

Technical Parameters comparison:

The candidate ALFA GATE MAX Implants share the same implant design, raw materials and implants' measurements as its reference device SGS K133362. Minor difference is related to implant surface, the ALFA GATE MAX implant is provided with surface treatment of Sand Blast and acid etched, which is demonstrated as substantially equivalent per recommendations of the FDA Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Therefore, ALFA GATE MAX Implants can be considered substantially equivalent to its reference device SGS K133362.

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

Image /page/12/Picture/0 description: The image shows the logo for AlfaGate Dental Implants Experts. The logo consists of a circular design with six sections, each in a different color: blue, green, yellow, orange, yellow, and green. To the right of the circular design is the text "AlfaGate" in a dark blue, sans-serif font. Below "AlfaGate" is the text "DENTAL IMPLANTS EXPERTS" in a smaller, sans-serif font.

Characteristic	CandidateSLIM Implants (Cat# SCA)	Reference DeviceSGS P7S Integral Groovy Implant
510(k) number	K182143	K133362
Manufacturer	Alfa Gate Mazen Ltd	SGS International Ltd
Product Name	SLIM Implants	P7S Integral Groovy Implant
Thread Design	Tapered, Double Thread	Tapered, Double Thread
Measurementsmm	3.0 Ø: 10, 11.5, 13, 153.3 Ø: 10, 11.5, 13, 153.75 Ø: 10, 11.5, 13, 15	3.0 Ø: 10, 11.5, 13, 163.2 Ø: 10, 11.5, 13, 163.75 Ø: 10, 11.5, 13, 164.2 Ø: 10, 11.5, 13, 165.0 Ø: 10, 11.5, 13, 166.0 Ø: 10, 11.5, 13, 16
Connection	One piece implant	One piece implant
Material	Ti 6Al-4V ELI	Ti 6Al-4V ELI
Surface	Calcium Phosphate Coating	Calcium Phosphate Coating
Self tapping	✓	✓
Sterilization	Gamma Ray	Gamma Ray
Packaging	Double packaging	Double packaging

Technical Parameters comparison:

The candidate ALFA GATE SLIM Implants share the same implant design, raw materials, implants' measurements and surface treatment as its reference device SGS K133362. Therefore, ALFA GATE SLIM Implants can be considered substantially equivalent to its reference device SGS K133362.

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

Image /page/13/Picture/0 description: The image shows the logo for AlfaGate Dental Implants Experts. The logo consists of a hexagon made of curved lines in the colors orange, yellow, green, and blue. To the right of the hexagon is the text "AlfaGate" in a dark blue, sans-serif font, and below that is the text "DENTAL IMPLANTS EXPERTS" in a smaller, lighter font.

SE - Dental Abutments:

Internal Hex

	Candidate	Primary Predicate
	Alfa Gate Mazen Itd	SGS International Itd
K Number	K182143	K182219
Product Name	Straight abutment Cat#AGM-101Straight abutment Cat#AGM-101H	Straight Titanium AbutmentS1WN,S1D, S1ND, S1WD, S1W, S1W8D, S1W8
Dimensions mm	Regular (RP), Length: 10.2	Narrow: Wide - Length:9Normal: Length: 7, 9, 12, 15Narrow: Length: 7, 9Wide: Length:9, 12S1W8D, S1W8 - 8mm wide with 10mm length
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal conical
Restoration	Cement Retained	Cement Retained
	Candidate	Reference Device
	Alfa Gate Mazen Itd	SGS International
K Number	K182143	K133362
Product Name	15° Abutment Cat#AGM-102	Angular Titanium Abutment, S2N, S2L, S2A
Dimensions mm	Regular (RP), Length: 9.5 - Angle 15	Narrow: Angle 15°, - length 9 mmNormal: Angle 15°, 25°- Length 9, 11 mmNormal: Height 1,2, 3 Length 9, 11
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex
Restoration	Cement Retained	Cement Retained
	Candidate	Primary Predicate
	Alfa Gate Mazen Itd	SGS International Itd
K Number	K182143	K182219
Product Name	Thin abutment Cat#AGM-104Wide abutment Cat#AGM-110	Straight Titanium AbutmentS1WN,S1D, S1ND, S1WD, S1W, S1W8D, S1W8
Dimensions mm	Thin , Length: 10Wide , Length: 11.5	Narrow: Wide - Length:9Normal: Length: 7, 9, 12, 15Narrow: Length: 7, 9Wide: Length:9, 12S1W8D, S1W8 - 8mm wide with 10mm length
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal conical
Restoration	Cement Retained	Cement Retained
	Candidate	Primary Predicate
	Alfa Gate Mazen Itd	SGS International Itd
K Number	K182143	K182219
Product Name	High base Abutment Cat#AGM-108	Straight Titanium AbutmentS1WN,S1D, S1ND, S1WD, S1W, S1W8D, S1W8
Dimensions mm	RN , Length: 13.5 mm	Narrow: Wide - Length:9Normal: Length: 7, 9, 12, 15Narrow: Length: 7, 9Wide: Length:9, 12S1W8D, S1W8 - 8mm wide with 10mm length
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal conical
Restoration	Cement Retained	Cement Retained
	Candidate	Primary Predicate
	Alfa Gate Mazen Itd	SGS International Itd
K Number	K182143	K182219
Product Name	Long neck Abutment Cat#AGM-109	Straight Titanium AbutmentS1WN,S1D, S1ND, S1WD, S1W, S1W8D, S1W8
Dimensions mm	RN , Length: 14.5 mm	Narrow: Wide - Length:9Normal: Length: 7, 9, 12, 15Narrow: Length: 7, 9Wide: Length:9, 12S1W8D, S1W8 - 8mm wide with 10mm length
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal conical
Restoration	Cement Retained	Cement Retained
	Candidate	Primary Predicate
	Alfa Gate Mazen Itd	SGS International Itd
K Number	K182143	K182219
Product Name	Angulated abutment 15° S-Line Cat#AGM-115S	Angular Abutments S2D, S2S, S2DS
Dimensions mm	NP, Length: 11 - Angle 15	NP,SLIM Length :11 - Angle 15, ,25
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal conical
Restoration	Cement Retained	Cement Retained
	Candidate	Primary Predicate
	Alfa Gate Mazen Itd	SGS International Itd
K Number	K182143	K182219
Product Name	S-Line straight abutment Cat# AGM-	S-Lock Abutments S35N, S35D,S35
100S
Dimensions mm	NP, Length: 10 mm	Narrow Diameter: 3.0 Height: 1, 2, 3;Regular Diameter: 3.75 Height: 1,2, 3,4,5,6
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Conical
Restoration	Cement Retained	Cement Retained
	Candidate	Primary Predicate
	Alfa Gate Mazen Ltd	SGS International Ltd
K Number	K182143	K182219
Product Name	Cementing post wide short Cat# AGM-104S	Straight Titanium AbutmentS1WN,S1D, S1ND, S1WD, S1W, S1W8D,S1W8
Dimensions mm	NP, Length: 7 mm	Narrow: Wide - Length:9Normal: Length: 7, 9, 12, 15Narrow: Length: 7, 9Wide: Length:9, 12S1W8D, S1W8 - 8mm wide with 10mm length
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal conical
Restoration	Cement Retained	Cement Retained
	Candidate	Primary Predicate
	Alfa Gate Mazen Ltd	SGS International Ltd
K Number	K182143	K182219
Product Name	Multi unit straight abutment Cat# AGM-505Titanium Sleeve	S16 The straight one-piece Multi-unitAbutment
Dimensions mm	NP, Length: 7 mm	RP, Height: 1,2,3,4,5 mmRelated accessories:H-S16/S17 healing cap, T-S16/S17 Titaniumsleeve, TW-S16/S17 Titanium sleeve, T3-S16/S17 adaptor
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex
Restoration	Screw Retained	Screw Retained
	Candidate	Primary Predicate
	Alfa Gate Mazen Ltd	SGS International Ltd
K Number	K182143	K182219
Product Name	Metal housing Cat# AGM-105-M	Metal cap (S8-Metal Cap)
Dimensions mm	RP	RP
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex
	Candidate	Primary Predicate
	Alfa Gate Mazen Itd	SGS International Itd
K Number	K182143	K182219
Product Name	Shoulder Abutment Cat#AGM-602-X	Straight Titanium AbutmentS1WN,S1D, S1ND, S1WD, S1W, S1W8D, S1W8
Dimensions mm	RP , Height 1,2,3,4 mm	Narrow: Wide - Length:9Normal: Length: 7, 9, 12, 15Narrow: Length: 7, 9Wide: Length:9, 12S1W8D, S1W8 - 8mm wide with 10mm length
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal conical
Restoration	Cement Retained	Cement Retained
	Candidate	Primary Predicate
	Alfa Gate Mazen Itd	SGS International Itd
K Number	K182143	K182219
Product Name	Esthetic Abutment Cat#AGM-802-X	Straight Titanium AbutmentS1WN,S1D, S1ND, S1WD, S1W, S1W8D, S1W8
Dimensions mm	RP , Height 1,2,3,4 mm	Narrow: Wide - Length:9Normal: Length: 7, 9, 12, 15Narrow: Length: 7, 9Wide: Length:9, 12S1W8D, S1W8 - 8mm wide with 10mm length
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal conical
Restoration	Cement Retained	Cement Retained
	Candidate	Primary Predicate
	Alfa Gate Mazen Itd	SGS International Itd
K Number	K182143	K182219
Product Name	Concave Esthetic Abutment Cat#AGM-802-XC	Straight Titanium AbutmentS1WN,S1D, S1ND, S1WD, S1W, S1W8D, S1W8
Dimensions mm	RP , Height 1,2,3,4 mm	Narrow: Wide - Length:9Normal: Length: 7, 9, 12, 15Narrow: Length: 7, 9Wide: Length:9, 12S1W8D, S1W8 - 8mm wide with 10mm length
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal conical
Restoration	Cement Retained	Cement Retained

	Candidate	Primary Predicate
	Alfa Gate Mazen Itd	SGS International Itd
K Number	K182143	K182219
Product Name	Standard short Abutment Cat# AGM-101SWide short Abutment Cat# AGM-110S	Straight Titanium Abutment
		S1WN,S1D, S1ND, S1WD, S1W, S1W8D,S1W8
Dimensions mm	RP, Length: 8 mmWide, Length: 7.5 mm	Narrow: Wide - Length:9
		Normal: Length: 7, 9, 12, 15
		Narrow: Length: 7, 9
		Wide: Length:9, 12
		S1W8D, S1W8 - 8mm wide with 10mm length
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal conical
Restoration	Cement Retained	Cement Retained

	Candidate	Reference Device
	Alfa Gate Mazen Itd	SGS International
K Number	K182143	K133362
Product Name	15° short Abutment Cat# AGM-102S	Angular Titanium Abutment,S2N,S2L, S2A
Dimensions mm	Regular (RP), Length: 7 - Angle 15	Narrow: Angle 15°, - length 9 mm
		Normal: Angle 15°, 25°- Length 9, 11 mm
		Normal: Height 1,2, 3 Length 9, 11
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex
Restoration	Cement Retained	Cement Retained

	Candidate	Reference Device
	Alfa Gate Mazen Itd	SGS International
K Number	K182143	K133362
Product Name	15° Thin Abutment Cat# AGM-102T	Angular Titanium Abutment,S2N,S2L, S2A
Dimensions mm	RP, Length: 11 - Angle 15	Narrow: Angle 15°, - length 9 mm
		Normal: Angle 15°, 25°- Length 9, 11 mm
		Normal: Height 1,2, 3 Length 9, 11
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex
Restoration	Cement Retained	Cement Retained

	Candidate	Primary Predicate
	Alfa Gate Mazen Itd	SGS International Itd
K Number	K182143	K182219
Product Name	15° Esthetic Abutment Cat# AGM-102-ExConcave Angulated Abutment 15° Cat#AGM-102-ExC	Angular Titanium Abutment,S2N, S2AN,S2AD,S2LD
Dimensions mm	RP, Height 1,2,3,4 - Angle 15	Narrow: Angle 25° - length 9 mmNarrow Anatomic: Angle 15°,25° - Height 1,2 mmRegular Anatomic: 3.75mm, Angle 15°,25° - Height 1,2,3,4Regular: 3.75mm, Length 13mm, Angle 15°,25°
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex/conical
Restoration	Cement Retained	Cement Retained
	Candidate	Primary Predicate
	Alfa Gate Mazen Itd	SGS International Itd
K Number	K182143	K182219
Product Name	Alfa lock abutment Cat# AGM-106-x	S35N, S35D, S35, S-Lock Abutments
Dimensions mm	RP, Height 2,3,4,5	Narrow Diameter:3.0 Height: 1, 2, 3;Regular Diameter: 3.75 Height: 1,2, 3,4,5,6
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex/conical
Restoration	Screw Retained Overdenture	Screw Retained Overdenture
Relatedaccessories	Metal housing Alfa gate Cat# AGM-106-MPlastic caps	Silicon caps: soft, standard, strong; Metal cap(MM-LFA50)
	Candidate	Reference Device
	Alfa Gate Mazen Itd	SGS International
K Number	K182143	K133362
Product Name	Ball Abutment Cat# AGM-105-x	Overdenture Ball attachment S3N, S3
Dimensions mm	RP, Heights 1,2,3,4,5,6,7 mm	Narrow: Length:1,2,3,4Normal: Length:1,2,3,4,5,6,7
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex
Restoration	Screw Retained Overdenture	Screw Retained Overdenture
	Candidate	Reference Device
	Alfa Gate Mazen Itd	SGS International
K Number	K182143	K133362
Product Name	Ball Abutment Concave Cat# AGM-105-xC	Overdenture Ball attachment S3N, S3
Dimensions mm	RP, Heights 1,2,3,4,5 mm	Narrow: Length:1,2,3,4Normal: Length:1,2,3,4,5,6,7
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex
Restoration	Screw Retained Overdenture	Screw Retained Overdenture
	Alfa Gate Mazen Itd	SGS International
K Number	K182143	K133362
Product Name	Ball Abutment S-Line Cat# AGM-105-xS	Overdenture Ball attachment S3N, S3
Dimensions mm	NP, Heights 2,3,4,5 mm	Narrow: Length:1,2,3,4Normal: Length:1,2,3,4,5,6,7
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex
Restoration	Screw Retained Overdenture	Screw Retained Overdenture
	Candidate	Reference Device
	Alfa Gate Mazen Itd	SGS International
K Number	K182143	K133362
Product Name	Healing cap Cat# AGM203-xWide Healing cap Cat# AGM-203-xWHealing cap S-LINE Cat# AGM-203-xSConcave Healing cap Cat# AGM-203-xC	Healing Abutments (HN,HNN,HWN,H,HN, HW)
Dimensions mm	RP, WP, Heights 1,2,3,4,5,6,7 mmNP, Heights 2,3,4,5 mmConcave : RP, WP, Heights 1,2,3,4,5 mm	Narrow, Length: 2,3,4Normal, Length: 2,3,4,5,6Wide, Length: 3,5
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex
Restoration	Screw Retained Overdenture	Screw Retained Overdenture
	Candidate	Reference Device
	Alfa Gate Mazen Itd	SGS International Itd
K Number	K182143	K182219
Product Name	Anatomic Abutment Cat# AGM-207-xF	S16 The straight one-piece Multi-unitAbutment
Dimensions mm	StraightRP , Height: 1,2,3,4,5 mmAnatomic sleeve AGM-207-PF (plasticburn cap)Multi unit straight abutment Cat# AGM-505(=metal sleeve)	StraightRP , Height: 1,2,3,4,5 mmRelated accessories:H-S16/S17 healing cap, T-S16/S17 Titaniumsleeve, TW-S16/S17 Titanium sleeve, T3-S16/S17 adaptor
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex
Restoration	Screw Retained	Screw Retained
	Candidate	Predicate
	Candidate	Primary Predicate
	Alfa Gate Mazen Itd	SGS International Itd
K Number		K182219
Product Name	Anatomic straight Abutment(Cat# ASAC)	Straight Titanium AbutmentS1WN,S1D, S1ND, S1WD, S1W, S1W8D, S1W8
Dimensions mm	Narrow (NP), Height: 1,2,3,4Regular (RP), Height: 1,2,3,4	Narrow: Wide - Length:9Normal: Length: 7, 9, 12, 15Narrow: Length: 7, 9Wide: Length:9, 12S1W8D, S1W8 - 8mm wide with 10mm length
Material	Titanium alloy Ti-6AI-4V-ELI.	Titanium alloy Ti-6AI-4V-ELI.
Connection	Internal Conical Connection	Internal conical
Restoration	Cement Retained	Cement Retained
	Candidate	Primary Predicate
	Alfa Gate Mazen Itd	SGS International Itd
K Number	K182143	K182219
Product Name	Standard straight abutment(Cat# SSAC)	Straight Titanium AbutmentS1WN,S1D, S1ND, S1WD, S1W, S1W8D, S1W8
Dimensions mm	Narrow (NP), Length: 9, 13Regular (RP), Length: 9, 13	Narrow: Wide - Length:9Normal: Length: 7, 9, 12, 15Narrow: Length: 7, 9Wide: Length:9, 12S1W8D, S1W8 - 8mm wide with 10mm length
Material	Titanium alloy Ti-6AI-4V-ELI.	Titanium alloy Ti-6AI-4V-ELI.
Connection	Internal Conical Connection	Internal Conical Connection
Restoration	Cement Retained	Cement Retained
	Candidate	Primary Predicate
	Alfa Gate Mazen Itd	SGS International Itd
K Number	K182143	K182219
Product Name	Ball attachment(Cat# BAC)	Overdenture Ball Attachments P7N (K133362)WPKxx, S3D - Ball Attachment
Dimensions mm	Narrow (NP), Height: 1,2,3,4,5,6Regular (RP), Height: 1,2,3,4,5,6	Narrow: NP, Height: 1,2,3,4; (K133362) int. hexRegular (RP), Height: 1,2,3,4,5,6
Material	Titanium alloy Ti-6AI-4V-ELI.	Titanium alloy Ti-6AI-4V-ELI.
Connection	Internal Conical Connection	Internal Conical Connection
Restoration	Overdenture	Overdenture
	Candidate	Primary Predicate
	Alfa Gate Mazen Itd	SGS International Itd
K Number	K182143	K182219
Product Name	Healing Cap(Cat# HCC xxx)	Healing Abutments(HD,HND,HW7D,HW8D,HWD)
Dimensions mm	Narrow (NP), Height: 2,3,4,5,6,7Regular (RP), Height: 2,3,4,5,6,7	Narrow, Length: 2,3,4;Normal, Length: 2,3,4,5,6Wide, Length: 3,5
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Conical Connection	Internal Conical Connection

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

Image /page/14/Picture/0 description: The image shows the logo for AlfaGate Dental Implants Experts. The logo consists of a colorful hexagon-shaped icon on the left and the company name "AlfaGate" in a bold, dark blue font on the right. Below the company name, the words "DENTAL IMPLANTS EXPERTS" are written in a smaller, lighter font.

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

Image /page/15/Picture/0 description: The image contains the logo for AlfaGate Dental Implants Experts. The logo features a colorful, abstract hexagonal shape on the left, with the company name "AlfaGate" in a bold, dark blue font to the right. Below the company name, the words "DENTAL IMPLANTS EXPERTS" are written in a smaller, lighter font.

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

Image /page/16/Picture/0 description: The image shows the logo for AlfaGate Dental Implants Experts. The logo consists of a colorful hexagon shape on the left, with the name "AlfaGate" in a dark blue font to the right. Below the name is the text "DENTAL IMPLANTS EXPERTS" in a smaller, lighter font.

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

Image /page/17/Picture/0 description: The image shows the logo for AlfaGate Dental Implants Experts. The logo features a geometric shape on the left, composed of curved lines in shades of blue, green, yellow, and orange. To the right of the shape is the company name, "AlfaGate," in a dark blue, sans-serif font. Below the name, in smaller letters, is the phrase "DENTAL IMPLANTS EXPERTS."

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

Image /page/18/Picture/0 description: The image is the logo for AlfaGate Dental Implants Experts. The logo features a colorful, abstract hexagon shape on the left, with the company name "AlfaGate" in a bold, dark blue font to the right. Below the company name, the words "DENTAL IMPLANTS EXPERTS" are written in a smaller, lighter font.

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

Image /page/19/Picture/0 description: The image is a logo for AlfaGate Dental Implants Experts. The logo consists of a hexagon made of curved lines in the colors orange, yellow, blue, and green. To the right of the hexagon is the text "AlfaGate" in a dark blue, sans-serif font. Below the name is the text "DENTAL IMPLANTS EXPERTS" in a smaller, sans-serif font.

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

Image /page/20/Picture/0 description: The image shows the logo for AlfaGate Dental Implants Experts. The logo features a colorful, circular icon on the left, made up of orange, yellow, green, and blue segments. To the right of the icon is the company name, "AlfaGate," in a bold, dark blue font. Below the name, in smaller letters, is the text "DENTAL IMPLANTS EXPERTS."

Conical Connection

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

Image /page/21/Picture/0 description: The image shows the logo for AlfaGate Dental Implants Experts. The logo consists of a circular icon made up of three curved shapes in blue, green, and yellow, followed by the text "AlfaGate" in a dark blue, sans-serif font. Below the company name, the words "DENTAL IMPLANTS EXPERTS" are written in a smaller, lighter font.

14 Summary of Equivalence:

As in similar to its primary predicate and reference devices ALFA GATE Dental Implants and Dental Abutments are Class II.

As in similar to its primary predicate and reference devices ALFA GATE Dental Implants are provided sterile by Gamma Ray irradiation; Dental Abutments are provided non sterile and prior to their use must be sterilized in an autoclave.

As in similar to its primary predicate and reference devices ALFA GATE Dental Implants and Abutments are for Single Use only.

SE discussion

The raised differences raised by the substantial equivalent tables and SE discussion are considered to be minor, e.g. abutments measurements which are covered by the range of primary predicate and referenced devices and/or very similar to them. The compatibility of implant/abutment was also verified by performance testing and therefore the candidate ALFA GATE® can be considered substantial equivalent to its primary predicate and reference devices.

15 Performance Testing:

Clinical Testing - No clinical data is included in this submission.

Sterilization Validation Test was carried out with accordance to ISO 11137 in order to demonstrate the substantial equivalence related to ALFA GATE® Dental Implants - Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met.

Shelf Life Test was carried out with accordance to ASTM F-1980 in order to validate the claimed shelf life of 5 years.

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

Image /page/22/Picture/0 description: The image is a logo for AlfaGate, a dental implants company. The logo features a colorful, circular icon on the left, with the company name "AlfaGate" in a bold, dark blue font to the right. Below the company name, the words "DENTAL IMPLANTS EXPERTS" are written in a smaller, lighter font. The icon is made up of six curved shapes in different colors, including blue, green, yellow, and orange.

Steam Sterilization Test was carried out with accordance to ISO 17665 in order to demonstrate the substantial equivalence related to ALFA GATE® Dental Abutments - Test results have demonstrated that the SAL of 10-9 was achieved and all testing requirements were met.

Endotoxin batch testing protocol per FDA Guidance Document Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.

Biocompatibility - ALFA GATE Dental Implants are made of Ti6AI4V ELI using the conventional manufacturing process. Cytotoxicity testing was carried out with accordance to ISO 10993-5 in order to demonstrate that the manufacturing process did not change the biocompatibility profile. Sensitization testing was carried out with accordance to ISO 10993-10. No additional biocompatibility testing was deemed necessary since the devices are constructed from medical quality raw material intended for surgical implants applications.

Fatigue test was carried out with accordance to ISO 14801 in order to verify the mechanical connection strength of implant/abutment, results have demonstrated the performance with the use of ALFA GATE® Dental Implants / Abutments.

Surface Test was carried out to ensure the cleanness of the implant surface results were met ALFA GATE requirements.

Risk Assessment was carried out with accordance to ISO 14971 and has demonstrated no new safety and/or effectiveness issues.

16 Conclusion:

As verified by substantial equivalence, risk assessment and bench testing ALFA GATE® Dental Implants System shares similarity to its predicated devices in terms of intended use, indication for use, raw material, technological characteristics and performance. Therefore, ALFA GATE® Dental Implants system is considered to be substantially equivalent to its predicate 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.