OsteoReady Dental Implant System

K173575 · Osteoready, LLC · DZE · Aug 17, 2018 · Dental

Device Facts

• Record ID: K173575
• Device Name: OsteoReady Dental Implant System
• Applicant: Osteoready, LLC
• Product Code: DZE · Dental
• Decision Date: Aug 17, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

System consists of endosseous dental implants, cover screws, healing caps, and abutments; used in surgical and restorative dental procedures to support prosthetic devices. Implants are threaded, tapered, self-tapping, root-form designs; manufactured from Grade 5 Titanium alloy (Ti-6Al-4V ELI) or PEEK. Operated by dental professionals in clinical settings. Device provides mechanical anchorage for artificial teeth; restores patient chewing function. Performance verified via mechanical fatigue testing (ISO 14801) and biocompatibility assessments. System includes various diameters and lengths to accommodate anatomical requirements.

Clinical Evidence

Bench testing only. Evidence includes sterilization validation (ISO 11137, ISO 17665), biocompatibility (ISO 10993-5, ISO 10993-10), fatigue testing (ISO 14801), shelf-life testing (ASTM F-1980), and packaging validation (ASTM D4169). LAL/endotoxin testing performed per USP 161/85. Risk assessment conducted per ISO 14971.

Technological Characteristics

Materials: Grade 5 Titanium alloy (Ti-6Al-4V ELI) per ISO 5832-3 and PEEK. Design: Threaded, tapered, self-tapping, root-form endosseous implants with internal hex connection. Surface: Sand-blasted and acid-etched. Sterilization: Gamma radiation for implants; steam sterilization for abutments. Dimensions: Various diameters (3.0mm to 6.0mm) and lengths (7mm to 15mm).

Indications for Use

Indicated for surgical and restorative applications in the upper or lower jaw to support prosthetic devices (artificial teeth) to restore chewing function. RidgeReady 3.0 implants are indicated for replacing a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MIS Implants System (K040807)

Reference Devices

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

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 ([e-mail]) or phone [phone] 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.

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#### 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)

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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 : [phone] | | |
| | | Fax : [phone] | | |
| 2 | Official Correspondent | Sterling Medical Registration | | |
| | Contact Person | Daniela Levy - Regulatory Consultant | | |
| | | 22815 Ventura blvd. | | |
| | | Woodland Hills, CA 91364 | | |
| | | Phone: [phone] | | |
| | | Email: [e-mail] | | |
| 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;

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

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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<br>sufficient primary<br>stability and<br>appropriate<br>occlusal loading for<br>the selected<br>technique.<br>NobelActive® 3.0<br>implants are<br>intended to replace<br>a lateral incisor in<br>the maxilla and/or a<br>central or lateral<br>incisor in the<br>mandible.<br>NobelActive® 3.0<br>implants are<br>indicated for single<br>unit restorations<br>only. | Implants: PIECE<br>DENTIN®<br>ONEPIECE<br>Implants 3.0 mmd<br>are intended for<br>placement at the<br>mandibular central<br>and lateral incisors<br>and maxillary and<br>lateral incisors.<br>Indicated also for<br>denture<br>stabilization using<br>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<br>Performance Implants | PRIMARY PREDICATE<br>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]<br>8, 10, 11.5, 13<br>15 [Not for 6.0 mmd] | 10, 11.5,13, 16 |
| Connection Type | Internal Hex | Internal Hex |
| Implant Body<br>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<br>operation | Conventional procedure | Conventional procedure |
| Self tapping | ✓ | ✓ |
| Sterilization | Gamma Ray | Gamma Ray |
| Packaging | Double packaging | Double packaging |

| CHARACTERISTIC | Candidate No.2<br>Performance Hybrid Implants | PRIMARY PREDICATE<br>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<br>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<br>operation | Conventional procedure | |
|---------------------------|------------------------|------------------|
| Self tapping | ✓ | ✓ |
| Sterilization | Gamma Ray | Gamma Ray |
| Packaging | Double packaging | Double packaging |

| CHARACTERISTIC | Candidate No.3<br>RidgeReady Implants | REFERENCE DEVICE<br>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<br>Standard - Length 1,2,3,4,5,6,7<br>Wide - Length 2,3,4,5,6,7<br>Narrow Diameter 3.0 - Height 1,3,5 | | Slim - Length 1,2,3,4,5,6,7<br>Standard - Length 1,2,3,4,5,6,7<br>Wide - Length 2,3,4,5,6,7<br>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<br>Abutment | Esthetic Angulated Abutment | Anatomic Angulated<br>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<br>Length 5, 7, 9, 12 mm | Diameter 3.75<br>Length 8.5, 11 | Diameter 3.8<br>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<br>Abutment | Anatomic Titanium<br>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<br>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<br>Collar | Straight Cement Abutment | Straight Titanium<br>Abutment |
| Dimensions mm | Diameter 4.5 Length 1,2,3,4 | Diameter NP, RP, WP Length<br>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<br>Height 1,2,3 mm | Diameter 3.0 mm<br>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,<br>Height 1,3,5 | | Diameter 3.0 mm<br>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,<br>Height 0.5,2.5,4.5 | Diameter NP,<br>Height 1,2,3,4 | |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | |
| Connection | Internal Hex | Internal Hex | |

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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.

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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.

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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.

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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.