Predicate Devices

Reference Devices

K142260, K120530, K163349, K112440, K151169

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a standard dental implant system and its components. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies focus on mechanical, sterilization, and biocompatibility testing, not algorithmic performance.

Therapeutic

Yes

The device, a dental implant system, is intended to restore a patient's chewing function and provide support for prosthetic devices, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.

Diagnostic

No

This device is a dental implant system used for surgical and restorative applications to support prosthetic devices, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly lists physical components such as dental implants, cover screws, healing caps, and abutment systems, which are hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, the OsteoReady® Dental Implant System is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the device is for surgical and restorative applications within the bone of the jaw to support prosthetic devices and restore chewing function. This is a direct intervention on the patient's body.
Device Description: The device description lists physical components like implants, screws, caps, and abutments, which are all surgically implanted or attached to the implant.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.

IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is surgically implanted inside the body for structural support.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

OsteoReady® Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. RidgeReady® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible.

Product codes (comma separated list FDA assigned to the subject device)

DZE, NHA

Device Description

OsteoReady® Dental Implant System is consist of endosseous form dental implants, internal hex implants, tapered design; cover screws, healing caps and abutment systems;

Dental Implants:

Performance implants are available as follow: Diameters 3.85, 4.2, 5.0 and 6.0mm with lengths, 7 ( 7mm only to 5&6 dmm), 8, 10, 11.5, 13, & 15 (15mm not for 6.0 dm);

Performance Hybrid Implants are available as follow: Diameter 3.85mm with lengths of 10, 11.5, 13 and 15mm;

RidgeReady Implants are available as follow: Diameter 3.0mm with lengths of 8.0, 10, 12, and 14mm;

Dental Abutments:

Healing Caps, Temporary Abutment, Anatomic Angulated Abutment 15, Anti-Rotation Abutment Slim / Standard, Anatomic Abutment, Angulated Abutment 15, Anti-Rotation Abutment with Collar, Ball Attachments, PEEK Temporary Abutment, O-Ring Abutments, Direct Clip Abutments, attachments for ball.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Oral Cavity

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

LAL/endotoxin testing was carried out with accordance to USP 161 and USP 85. Test results have met the criteria.

OsteoReady will not market its Dental Implant System as "non-pyrogenic".

Shelf Life Test was carried out with accordance to ASTM F-1980 in order to demonstrate substantial equivalence of OsteoReady® Dental Implants of 5 years shelf life.

Steam Sterilization Test was carried out with accordance to ISO 17665 in order to demonstrate substantial equivalence of OsteoReady® Dental Abutments - Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met.

Packaging validation test was carried out with accordance to ASTM D4169 in order to validate the safety of the device and packaging during transportation test results were meet the criteria.

Biocompatibility - OsteoReady uses the same raw material as was previously cleared under 510k K151169 titanium alloy Ti6Al4V Eli and uses the same conventional manufacturing process. Cytotoxicity testing was conducted with accordance to ISO 10993-5 to the used raw materials: Titanium alloy and for PEEK Abutments, in order to demonstrate that the manufacturing process did not change the biocompatibility profile. Irritation testing and Sensitization testing were conducted with accordance to ISO 10993-10, all test results met the criteria.

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 high performance with the use of OsteoReady® Dental Implants / Abutments.

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

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

MIS Implants System K040807

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

NobelActive K142260, DENTIN Implants System K120530, MIS K163349, A.B.Dental Implants System K112440, OsteoReady ZircoSeal Abutments K151169

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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

August 17, 2018

OsteoReady LLC % Daniela Levy Regulatory Consultant Sterling Medical Registration 22817 Ventura Blvd. Woodland Hills, California 91364

Re: K173575

Trade/Device Name: OsteoReady® Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 12, 2018 Received: July 25, 2018

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Andrew I. Steen -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image contains the logo for OsteoReady, a company that provides practical implant solutions. The logo consists of a stylized blue symbol on the left, resembling a stylized letter "U" made of curved lines. To the right of the symbol is the company name "OsteoReady" in a bold, blue font. Below the company name is the tagline "Practical Implant Solutions" in a smaller, lighter font.

Page 1 of 1

Indication for Use Statement

510(k) Number (if known): K173575

Device Name:

SECTION 4 -

OsteoReady® Dental Implant System

Indications for Use (Describe)

Indications for Use:

OsteoReady® Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. RidgeReady® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible.

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

区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 contains the logo for OsteoReady. The logo consists of a blue abstract symbol on the left, resembling a stylized eye or target. To the right of the symbol, the word "OsteoReady" is written in a bold, blue font. Below "OsteoReady", the phrase "Practical Implant Solutions" is written in a smaller, lighter blue font.

510(k) Summary (21 CFR 807.92)

510(k) Number K173575

1	Submission Owner	OsteoReady LLC
		Dr. Robert Gottlander
		150 Baker Ave. Ext. Ste.110
		Concord, MA 01742
		USA
		Phone : 206-812-7727
		Fax : 800-721-4907
2	Official Correspondent	Sterling Medical Registration
	Contact Person	Daniela Levy - Regulatory Consultant
		22815 Ventura blvd.
		Woodland Hills, CA 91364
		Phone: 1-213-787-3027
		Email: sterlingmedical2017@gmail.com
3	Prepared Date	August 16, 2018
4	Device Trade Name	OsteoReady® Dental Implant System
5	Regulation Description	Endosseous Dental Implants Abutment
6	Classification	Primary Product Code:		DZE
		Device Name		: Implant, endosseous, root-form
		Regulation No	:	872.3640
		Class	:	II
		Panel	:	Dental
		Secondary Product Code:		NHA
7	Reason for the Premarket Notification Submission	:		New Device

Identification of Legally Marketed Predicate Devices : 8 OsteoReady® Dental Implant System is substantially equivalent to the following: Primary Predicate: MIS Implants System K040807;

4

Image /page/4/Picture/0 description: The image shows the logo for OsteoReady, a company that provides practical implant solutions. The logo features a stylized blue symbol on the left, resembling a tooth or bone structure. To the right of the symbol is the company name "OsteoReady" in a bold, blue font, with the tagline "Practical Implant Solutions" in a smaller font underneath.

Reference Devices: NobelActive K142260; DENTIN Implants System K120530; MIS K163349; A.B.Dental Implants System K112440; OsteoReady ZircoSeal Abutments K151169;

in terms of intended use, indication for use, raw material, technological characteristics and performance. The predicate devices are a Class II medical device.

റി Device Description:
OsteoReady® Dental Implant System is consist of endosseous form dental implants, internal hex implants, tapered design; cover screws, healing caps and abutment systems;

Dental Implants:

Performance implants are available as follow: Diameters 3.85, 4.2, 5.0 and 6.0mm with lengths, 7 ( 7mm only to 5&6 dmm), 8, 10, 11.5, 13, & 15 (15mm not for 6.0 dm);

Performance Hybrid Implants are available as follow: Diameter 3.85mm with lengths of 10, 11.5, 13 and 15mm;

RidgeReady Implants are available as follow: Diameter 3.0mm with lengths of 8.0, 10, 12, and 14mm;

Dental Abutments:

Healing Caps, Temporary Abutment, Anatomic Angulated Abutment 15, Anti-Rotation Abutment Slim / Standard, Anatomic Abutment, Angulated Abutment 15, Anti-Rotation Abutment with Collar, Ball Attachments, PEEK Temporary Abutment, O-Ring Abutments, Direct Clip Abutments, attachments for ball.

10 Indication for Use:
OsteoReady® Dental Implant System is indicated for use in surqical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. RidgeReady® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible.
11 Performance Standards or Special Controls
- . ISO 7405 Second edition 2008-12-15 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.

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Image /page/5/Picture/0 description: The image contains the logo for OsteoReady, a company that provides practical implant solutions. The logo features a stylized blue icon on the left, resembling a tooth or bone structure. To the right of the icon is the company name, "OsteoReady," in a bold, blue font. Below the name is the tagline "Practical Implant Solutions" in a smaller, lighter blue font.

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 fatigue test for . endosseous dental implants.
FDA guidance document: Class II Special Controls Guidance Document: Root-form . Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff.
12 Substantial Equivalence

Indication for Use Table

| Candidate
OsteoReady
Dental Implant
System | PRIMARY
PREDICATE
Lance Implant | REFERENCE
DEVICE
NobelActive 3.0
Implants | REFERENCE
DEVICE
DENTIN Implant
System | REFERENCE
DEVICE
A.B.Dental
Devices |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K173575 | K040807 | K142260 | K120530 | K112440 |
| OsteoReady
LLC | MIS Implant
Technologies Ltd | Nobel Biocare USA
LLC | DENTIN Implants
Technologies Itd | A.B. Dental
Implants System |
| OsteoReady®
Dental Implant
System is
indicated for
use in surgical
and restorative
applications for
placement in
the bone of the
upper or lower
jaw to provide
support for
prosthetic
devices, such
as artificial
teeth, in order to
restore the
patient's
chewing
function.
RidgeReady®
3.0 implants are
intended to
replace a lateral
incisor in the
maxilla and/or a
central or lateral
incisor in the
mandible. | The MIS Dental
Implant System is
indicated for use in
surgical and
restorative
applications for
placement in the
bone of the upper
or lower jaw to
provide support for
prosthetic devices,
such as artificial
teeth, in order to
restore the patient's
chewing function. | NobelActive®
implants are
endosseous
implants intended
to be surgically
placed in the upper
or lower jaw bone
for anchoring or
supporting tooth
replacements to
restore patient
esthetics and
chewing function.
NobelActive®
implants are
indicated for single
or multiple unit
restorations in
splinted or non-
splinted
applications. This
can be achieved by
a 2-stage or 1-
stage surgical
technique in
combination with
immediate, early or
delayed loading
protocols, | DENTIN® Dental
Implants System is
indicated for use in
surgical and
restorative
applications for
placement in the
bone of the upper
or lower jaw to
provide support for
prosthetic devices,
such as artificial
teeth, in order to
restore the patient's
chewing function.
DENTIN® Dental
Implants System is
indicated also for
immediate loading
when good primary
stability is achieved
and with
appropriate
occlusal loading.
Two Stage
Implants:
CLASSIC, RAPID,
PRESTIGE.
One Stage | The AB Dental
Devices implants
are intended for
surgical placement
in the maxillary
and/or mandibular
arch to support
crowns, bridges, or
overdentures in
edentulous or
partially edentulous
patients. I7 Integral
implant, I5 Conical
implant,
P15
Temporary
abutment, P12-T,L
Temporary flat
connection
abutment, and P16
Straight adaptor
are appropriate for
immediate loading
when good primary
stability is achieved
and with
appropriate
occlusal loading. |

6

Image /page/6/Picture/0 description: The image shows the logo for OsteoReady. The logo consists of a blue abstract symbol on the left, resembling a stylized "U" shape with concentric curves. To the right of the symbol is the company name, "OsteoReady," in a bold, blue font. Below the name, in a smaller font, is the tagline "Practical Implant Solutions."

| | recognizing
sufficient primary
stability and
appropriate
occlusal loading for
the selected
technique.
NobelActive® 3.0
implants are
intended to replace
a lateral incisor in
the maxilla and/or a
central or lateral
incisor in the
mandible.
NobelActive® 3.0
implants are
indicated for single
unit restorations
only. | Implants: PIECE
DENTIN®
ONEPIECE
Implants 3.0 mmd
are intended for
placement at the
mandibular central
and lateral incisors
and maxillary and
lateral incisors.
Indicated also for
denture
stabilization using
multiple implants. |
|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Discussion

OsteoReady shares the same indication for use as its primary predicate. The only difference is related to statement of RidgeReady® 3.0 implants which are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. This statement is similar to the reference devices NobelActive K142260 and DENTIN K120530 since these reference devices also introduce the 3.0ø implants, whereas the primary predicate doesn't introduce the 3.0ø implants . Therefore, OsteoReady doesn't introduce any safety or efficacy issues.

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Image /page/7/Picture/0 description: The image is a logo for OsteoReady, a company that provides practical implant solutions. The logo consists of a blue circular icon on the left and the company name "OsteoReady" in blue text on the right. Below the company name is the tagline "Practical Implant Solutions" in a smaller, lighter blue font. The icon is a stylized representation of a tooth or bone structure, with concentric circles forming the outer shape.

Dental Implants System

| CHARACTERISTIC | Candidate No.1
Performance Implants | PRIMARY PREDICATE
Lance Implant |
|---------------------------|------------------------------------------------------------------|-----------------------------------------|
| 510k | K173575 | K040807 |
| Company Name | OsteoReady LLC | MIS Implant Technologies Ltd |
| Device Design | Threaded, root form endosseous implants | Threaded, root form endosseous implants |
| Classification | Class 2 872.3640 P.Code DZE | Class 2 872.3640 P.Code DZE |
| Material | GR-5 Titanium Ti-6Al-4V ELI | GR-5 Titanium Ti-6Al-4V ELI |
| Diameters mmd | 3.85, 4.2, , 5, 6 | 3.75, 4.2, 5 |
| Lengths mml | 7 [only to 5 & 6 mmd]
8, 10, 11.5, 13
15 [Not for 6.0 mmd] | 10, 11.5,13, 16 |
| Connection Type | Internal Hex | Internal Hex |
| Implant Body
Contour | Tapered, Self Tapping | Tapered, Self Tapping |
| Coating / Surface | Sand Blast & Acid Etched | Sand Blast & Acid Etched |
| Anatomical Site | Oral Cavity | Oral Cavity |
| Principle of
operation | Conventional procedure | Conventional procedure |
| Self tapping | ✓ | ✓ |
| Sterilization | Gamma Ray | Gamma Ray |
| Packaging | Double packaging | Double packaging |

| CHARACTERISTIC | Candidate No.2
Performance Hybrid Implants | PRIMARY PREDICATE
SEVEN Implants |
|-------------------------|-----------------------------------------------|-----------------------------------------|
| 510k | K173575 | K040807 |
| Company Name | OsteoReady LLC | MIS Implant Technologies Ltd |
| Device Design | Threaded, root form endosseous implants | Threaded, root form endosseous implants |
| Classification | Class 2 872.3640 P.Code DZE | Class 2 872.3640 P.Code DZE |
| Material | GR-5 Titanium Ti-6Al-4V ELI | GR-5 Titanium Ti-6Al-4V ELI |
| Diameters mmd | 3.85 | 3.75, 4.2, 5, 6 |
| Lengths mml | 10, 11.5, 13, 15 | 8, 10, 11.5, 13, 16 (N/A for 6mmd) |
| Connection Type | Internal Hex | Internal Hex |
| Implant Body
Contour | Tapered, Self Tapping | Tapered, Self Tapping |
| Coating / Surface | Sand Blast & Acid Etched | Sand Blast & Acid Etched |
| Anatomical Site | Oral Cavity | Oral Cavity |

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Image /page/8/Picture/0 description: The image shows the logo for OsteoReady. The logo consists of a blue circular icon on the left and the text "OsteoReady" in blue on the right. Below the text "OsteoReady" is the text "Practical Implant Solutions" in a smaller font size. The logo is simple and professional, and it conveys the company's focus on providing practical solutions for dental implants.

| Principle of

operation	Conventional procedure
Self tapping	✓	✓
Sterilization	Gamma Ray	Gamma Ray
Packaging	Double packaging	Double packaging

| CHARACTERISTIC | Candidate No.3
RidgeReady Implants | REFERENCE DEVICE
NobelActive 3.0 Implants |
|------------------------|-----------------------------------------|----------------------------------------------|
| 510k | K173575 | K142260 |
| Company Name | OsteoReady LLC | Nobel Biocare USA LLC |
| Device Design | Threaded, root form endosseous implants | Threaded, root form endosseous implants |
| Classification | Class 2 872.3640 P.Code DZE | Class 2 872.3640 P.Code DZE |
| Material | GR-5 Titanium Ti-6Al-4V EL | GR-5 Titanium Ti-6Al-4V ELI |
| Diameters dmm | 3.0 | 3.0, 3.5, 4.3, 5.0, 5.5 |
| Lengths Imm | 8, 10, 12, 14 | 7, 8.5, 10, 11.5, 13, 15, 18 |
| Connection Type | Internal Hex | Internal Hex |
| Implant Body Contour | Tapered, Self Tapping | Tapered, Self Tapping |
| Surface | Sand Blast & Acid Etched | TiUnite |
| Anatomical Site | Oral Cavity | Oral Cavity |
| Principle of operation | Conventional procedure | Conventional procedure |
| Self tapping | ✓ | ✓ |
| Sterilization | Gamma Ray | Gamma Ray |
| Packaging | Double packaging | Double packaging |

Dental Abutments System

	Candidate	Primary Predicate	Reference Device
Company / 510k	OsteoReady LLC K173575		DENTIN 510K 120530
Product Name	Healing Caps		Healing Caps
Dimensions mm	Slim - Length 1,2,3,4,5,6,7
Standard - Length 1,2,3,4,5,6,7
Wide - Length 2,3,4,5,6,7
Narrow Diameter 3.0 - Height 1,3,5		Slim - Length 1,2,3,4,5,6,7
Standard - Length 1,2,3,4,5,6,7
Wide - Length 2,3,4,5,6,7
Narrow Diameter 3.0 - Height 1,3,5
Material	Titanium alloy Ti-6Al-4V-ELI.		Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex		Internal Hex
Company / 510k	OsteoReady LLC K173575	MIS K040807	DENTIN 510K 120530
Product Name	Anatomic Angulated Titanium
Abutment	Esthetic Angulated Abutment	Anatomic Angulated
Titanium Abutment
Dimensions mm	Height 1,2,3,4 - Angle 15	Height 1,2,3 - Angle 15	Height 1,2,3,4 - Angle 15
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex	Internal Hex
Company / 510k	OsteoReady LLC K173575	MIS K040807	DENTIN 510K 120530
Product Name	Anti-Rotation Abutment Slim	Cemented Abutment	Slim Titanium Abutment
Dimensions mm	Diameter 3.8
Length 5, 7, 9, 12 mm	Diameter 3.75
Length 8.5, 11	Diameter 3.8
Length 5, 7, 9, 12, 15
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex	Internal Hex

Company / 510k	OsteoReady LLC K173575	MIS K040807	DENTIN 510K 120530
Product Name	Anti-Rotation Abutment	Cemented Abutment	Titanium Abutment
Dimensions mm	Diameter 4.5	Diameter 4.7	Diameter 4.5
	Length 5, 7, 9, 12	Length 11	Length 7, 9, 12
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex	Internal Hex

Company / 510k	OsteoReady LLC K173575	MIS K040807	DENTIN 510K 120530
Product Name	Anatomic Titanium Abutment	Anatomic transgingival
Abutment	Anatomic Titanium
Abutment
Dimensions mm	Height 1,2,3,4	Height 1,2,3,4	Height 1,2,3,4
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex	Internal Hex

Company / 510k	OsteoReady LLC	MIS K040807	DENTIN 510K 120530
Product Name	Angulated Titanium Abutment	Angulated Cement Abutment	Angulated Titanium
Abutment
Dimensions mm	Length 9 - Angle 15	Length 9,11 - Angle 15	Length 9,12 - Angle 15
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex	Internal Hex

	Candidate	Primary Predicate	Reference Device
Company / 510k	OsteoReady LLC K173575	MIS K040807	DENTIN 510K 120530
Product Name	Anti-Rotation Abutment with
Collar	Straight Cement Abutment	Straight Titanium
Abutment
Dimensions mm	Diameter 4.5 Length 1,2,3,4	Diameter NP, RP, WP Length
1,2,3,4	Diameter 4.5 Length 1,2,3,4
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex	Internal Hex
Product Name	Ball Attachment	Ball Attachment	Ball Attachment
Dimensions mm	Height 0.5,1,2,3,4,5,6	Height 1,2,3,4,5	Height 0.5,1,2,3,4,5,6
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex	Internal Hex
Related Components	Metal Caps, Silicon Caps	Metal Caps, Silicon Caps	Metal Caps, Silicon Caps
Company / 510k	OsteoReady LLC K173575	MIS K163349	DENTIN 510K 120530
Product Name	PEEK Temporary Abutment	Temporary plastic abutment	Straight curve minor - PEEK
Dimensions mm	Height 1,2,3,	NP,RP Height 1,2,3	Height 1,2,3,
Material	PEEK	PEEK	PEEK
Connection	Internal Hex	Internal Hex, conical	Internal Hex
Company / 510k	OsteoReady LLC K173575	MIS K040807	A.B.Dental Devices K112440
Product Name	O-Ring Abutments	Ball Attachment	Straight Adaptor P16
Dimensions mm	Diameter 3.0 mm	Diameter NP
Height 1,2,3 mm	Diameter 3.0 mm
Height 1,2,3,4 mm
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex	Internal Hex
Company / 510k	OsteoReady LLC K173575		A.B.Dental Devices K112440
Product Name	Direct Clip Abutments		Straight Adaptor P16
Dimensions mm	Diameter 3.0 mm,
Height 1,3,5		Diameter 3.0 mm
Height 1,2,3,4 mm
Material	Titanium alloy Ti-6Al-4V-ELI.		Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex		Internal Hex
	Candidate	Primary Predicate	Reference Device
Company / 510k	OsteoReady LLC K173575	MIS K040807
Product Name	Straight Abutments	Transgingival Abutment, NP
Dimensions mm	Diameter 3.0 mm,
Height 0.5,2.5,4.5	Diameter NP,
Height 1,2,3,4
Material	Titanium alloy Ti-6Al-4V-ELI.	Titanium alloy Ti-6Al-4V-ELI.
Connection	Internal Hex	Internal Hex

9

Image /page/9/Picture/0 description: The image shows the logo for OsteoReady. The logo consists of a blue circular design on the left, resembling a stylized eye or target. To the right of the circular design is the text "OsteoReady" in a bold, blue font. Below "OsteoReady" is the tagline "Practical Implant Solutions" in a smaller, lighter blue font.

10

Image /page/10/Picture/0 description: The image contains the logo for OsteoReady, a company that provides practical implant solutions. The logo consists of a blue symbol on the left and the company name "OsteoReady" in blue text on the right. Below the company name, there is a tagline "Practical Implant Solutions" in a smaller font size.

11

Image /page/11/Picture/0 description: The image shows the logo for OsteoReady, a company that provides practical implant solutions. The logo features a stylized blue symbol on the left, resembling a target or a stylized letter 'U'. To the right of the symbol is the company name, "OsteoReady," in a bold, blue font. Below the company name is the tagline "Practical Implant Solutions" in a smaller, lighter blue font.

13 Summary of Equivalence:

OsteoReady® Dental Implant System: Performance Implants & Performance Hybrid Implants share similarity to MIS Implants System K040807; RidgeReady Implants share similarity to NobelActive K142260; in terms of intended use, indication for use, technological characteristics, design, raw material and performance. The minor difference is regarding to OsteoReady diameter size which is wider, however it doesn't introduce any new safety or efficacy issues. OsteoReady Dental Implant system is made of Titanium alloy Ti-6AI-4V-ELI as in similar to its primary predicate.

OsteoReady® Dental Abutment System shares similarity to MIS Implants System K040807, K163349; DENTIN Implants System K120530; A.B.Dental Implants System K112440; in terms of intended use, indication for use, technological characteristics, design, raw material and performance.

The minor difference is regarding to measurements related few abutments types, however it doesn't introduce any new safety or efficacy issues since similar measurements are already exist in the market.

As demonstrated by the substantial equivalent table, the minor differences of OsteoReady LLc vs. its predicate and reference devices raise no new safety or/and effectiveness issues and therefore OsteoReady® Dental Implant System is considered to be substantial equivalent to its predicate and reference devices.

14 Non Clinical Performance:

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

LAL/endotoxin testing was carried out with accordance to USP 161 and USP 85. Test results have met the criteria.

OsteoReady will not market its Dental Implant System as "non-pyrogenic".

Shelf Life Test was carried out with accordance to ASTM F-1980 in order to demonstrate substantial equivalence of OsteoReady® Dental Implants of 5 years shelf life.

Steam Sterilization Test was carried out with accordance to ISO 17665 in order to demonstrate substantial equivalence of OsteoReady® Dental Abutments - Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met.

12

Image /page/12/Picture/0 description: The image shows the logo for OsteoReady. The logo features a blue abstract design on the left, resembling a stylized letter "U" or a series of concentric arcs. To the right of the design is the company name "OsteoReady" in a bold, blue font. Below the name, in a smaller font, is the tagline "Practical Implant Solutions."

Packaging validation test was carried out with accordance to ASTM D4169 in order to validate the safety of the device and packaging during transportation test results were meet the criteria.

Biocompatibility - OsteoReady uses the same raw material as was previously cleared under 510k K151169 titanium alloy Ti6Al4V Eli and uses the same conventional manufacturing process. Cytotoxicity testing was conducted with accordance to ISO 10993-5 to the used raw materials: Titanium alloy and for PEEK Abutments, in order to demonstrate that the manufacturing process did not change the biocompatibility profile. Irritation testing and Sensitization testing were conducted with accordance to ISO 10993-10, all test results met the criteria.

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 high performance with the use of OsteoReady® Dental Implants / Abutments.

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

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

15 Conclusion:

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