OsteoReady ZircoSeal Abutments

K151169 · Osteoready, LLC · NHA · Oct 8, 2015 · Dental

Device Facts

• Record ID: K151169
• Device Name: OsteoReady ZircoSeal Abutments
• Applicant: Osteoready, LLC
• Product Code: NHA · Dental
• Decision Date: Oct 8, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OsteoReady ® ZircoSeal® Dental Abutments are intended to be used with an endosseous implant to aid prosthetic rehabilitation in order to restore the patient's chewing function. OsteoReady® ZircoSeal® Abutments are compatible with DENTIN® Dental Implant System - Prestige Implant System diameters 3.75, 4.2, 5 & 6;

Device Story

OsteoReady ZircoSeal Abutments are straight, anti-rotation dental abutments fabricated from titanium alloy (Ti-6Al-4V ELI). They feature a zirconium nitride surface treatment (trade name ZircoSeal). The device is intended for use with endosseous dental implants to support prosthetic rehabilitation and restore chewing function. The abutments are provided non-sterile and must be sterilized by the clinician via autoclave before use. They are single-use devices. The clinician selects the appropriate abutment based on the implant system and dimensions, then secures it to the implant to serve as a base for the final dental prosthesis. The device does not provide angle correction and is not intended for chairside or CAD/CAM modification. By providing a stable connection between the implant and the prosthesis, the device enables the restoration of oral function for the patient.

Clinical Evidence

No clinical data included. Bench testing included steam sterilization validation (achieving SAL 10^-6 per ISO 17665-1/2 and ANSI/AAMI ST79:2010) and biocompatibility testing per ISO 10993-5. Surface treatment evaluation was conducted per FDA guidance for Endosseous Dental Implants and Abutments.

Technological Characteristics

Material: GR-5 Titanium (Ti-6Al-4V ELI) per ISO 5832-3. Surface: Zirconium nitride (ZircoSeal). Design: Straight, anti-rotation, internal hex connection. Dimensions: Diameters 3.75mm and 4.5mm; lengths 5-13mm or cuff heights 1-4mm. Sterilization: Autoclave (provided non-sterile).

Indications for Use

Indicated for patients requiring prosthetic rehabilitation via endosseous dental implants to restore chewing function. Compatible with DENTIN Prestige Implant System (diameters 3.75, 4.2, 5, and 6).

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

• PerioType X-Pert (K123386)
• AB Dental Devices Implants and Accessories (K112440)
• A.B. Dental Devices (K051719)
• IQ Implant System (K130829)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 8, 2015

OsteoReady LLC c/o Ms. Daniela Levy Regulatory Consultant Sterling Medical Registration 22817 Ventura Blvd Woodland Hills, California 91364

Re: K151169

Trade/Device Name: OsteoReady® ZircoSeal® Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 26, 2015 Received: September 9, 2015

Dear Ms. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. 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 icon on the left, resembling concentric waves forming a shape. To the right of the icon is the company name, "OsteoReady," in a bold, dark blue font. Below the company name is the tagline "Practical Implant Solutions" in a smaller, lighter blue font.

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| SECTION 4 - | Indication for Use Statement |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| 510(k) Number (if known): | |
| K151169 | |
| Device Name: | |
| OsteoReady® ZircoSeal® Abutments | |
| Indications for Use ( <i>Describe</i> ) | |
| Indications for Use: | |
| OsteoReady ® ZircoSeal® Dental Abutments are intended to be used with an endosseous<br>implant to aid prosthetic rehabilitation in order to restore the patient's chewing function. | |
| OsteoReady® ZircoSeal® Abutments are compatible with DENTIN® Dental Implant System<br>- Prestige Implant System diameters 3.75, 4.2, 5 & 6; | |

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 displays the logo for OsteoReady, a company specializing in practical implant solutions. Below the logo, the text "SECTION 5 - 510(k) Summary (21 CFR 807.92)" is present. This suggests the image is part of a document related to regulatory compliance, specifically a 510(k) summary as required by the Code of Federal Regulations for medical devices.

# 510(k) Number K151169

| 1 | Submission | OsteoReady LLC | | | |
|---|---------------------------------------------------------------------------------|--------------------------------------------------|------------|----------|--|
| | Owner | Michael D. Silverman, DMD, DICOI | | | |
| | | 106 Lenora Street | | | |
| | | Seattle, WA 98121 | | | |
| | | USA | | | |
| | | Phone : [phone] | | | |
| | | Fax : [phone] | | | |
| 2 | Official Correspondent | Sterling Medical Registration | | | |
| | Contact Person | Daniela Levy - Regulatory Consultant | | | |
| | | 22817 Ventura blvd. | | | |
| | | Woodland Hills, CA 91364 | | | |
| | | Phone: [phone] | | | |
| | | Email: [e-mail] | | | |
| 3 | Date Prepared | October 05, 2015 | | | |
| 4 | Device Trade Name | OsteoReady® ZircoSeal® Abutments | | | |
| 5 | Regulation Description | Endosseous Dental Implant Abutment | | | |
| 6 | Classification | Device Name : Abutment,Implant,Dental,Endosseous | | | |
| | | Product Code | : | NHA | |
| | | Regulation No | : | 872.3630 | |
| | | Class | : | II | |
| | | Panel | : | Dental | |
| 7 | Reason for the Premarket Notification Submission | : | New Device | | |
| 8 | Identification of Legally Marketed Predicate Devices : | | | | |
| | OsteoReady® ZircoSeal® Abutments are substantially equivalent to the following: | | | | |

#### Primary Predicate

- PerioType X-Pert (K123386); .
Reference Predicate

- . AB Dental Devices Implants and Accessories (K112440)
- A.B. Dental Devices (K051719) .

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Image /page/4/Picture/0 description: The image contains the logo for OsteoReady, a company that provides practical implant solutions. The logo consists of a stylized blue icon on the left, resembling a series of concentric arcs. To the right of the icon 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.

- IQ Implant System(K130829)
in terms of intended use, indication for use, raw material, technological characteristics and performance.

The predicate devices are a Class II medical device.

- တ Device Description:
OsteoReady® ZircoSeal® Abutments are Straight Anti-Rotation Abutments made of titanium alloy. OsteoReady® ZircoSeal® Abutments are available in the following measurements:

Slim Anti-Rotation Titanium Abutment with ZircoSeal®: Length 5,7,9,11,13 mm with Diameter 3.75 mm.

Anti-Rotation Titanium Abutment with ZircoSeal®: Length 5,7,9,11,13 mm Diameter 4.5 mm.

Anti-Rotation Straight Titanium Abutment with ZircoSeal®: Shoulder Length 1,2,3,4 mm Diameter 4.5 mm.

OsteoReady® ZiroSeal® Abutments are straight only and are not intended to be modified chairside or by CAD/CAM to provide an angle correction.

The ZircoSeal surface treatment is the trade name of zirconium nitride.

The ZircoSeal® simply indicates the signature zirconium nitride surface treatment of the abutment. The trade name is unrelated to claims of "sealing" of implant/abutment connection platform.

- 10 Indication for Use:
OsteoReady ® ZircoSeal® Dental Abutments are intended to be used with an endosseous implant to aid prosthetic rehabilitation in order to restore the patient's chewing function. OsteoReady® ZircoSeal® Abutments are compatible with DENTIN® Dental Implant System - Prestige Implant System diameters 3.75, 4.2, 5 & 6;

- 11 Performance Testing and Special Controls
Steam validation test was conducted in order to ensure safety assurance level of ( SAL) 10-6 related to OsteoReady® ZircoSeal® Abutments system.

Biocompatibility test was conducted according to ISO 10993-5, test results have met all applicable criteria. Additional biocompatibility justification was provided attesting that the raw material and surface treatments of the subject abutment is the same as the predicates.

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

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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 consists of 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 company name, in a smaller font, is the tagline "Practical Implant Solutions."

- 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.
- Sterilization validation according to to ISO 17665-1/2 and ANSI/AAMI . ST79:2010. Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met.
- . Surface treatment evaluation per the FDA guidance document for Endosseous Dental Implants and Abutments including chemical analysis and abrasion characteristics of the surface.

FDA guidance document: Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff.

| Substantial<br>Equivalent Table<br>CHARACTERISTIC | Candidate<br>Slim Anti Rotation<br>Abutment with ZircoSeal ® | REFERENCE PREDICATE<br>DEVICE<br>P3 Anti rotation abutment | REFERENCE<br>PREDICATE DEVICE<br>Slim Straight Abutment |
|---------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------|---------------------------------------------------------|
| 510k | | K112440, K051719 | K130829 |
| Company Name | OsteoReady LLC | A.B.Dental Devices Itd. | IQ Implants Itd |
| Device Design | Endosseous dental implant<br>abutment | Endosseous dental implant<br>abutment | Endosseous dental implant<br>abutment |
| Classification | Class II 872.3630<br>P.Code NHA | Class II 872.3630<br>P.Code NHA | Class II 872.3630<br>P.Code NHA |
| Material | GR-5 Titanium Ti-6Al-4V ELI | GR-5 Titanium Ti-6Al-4V ELI | GR-5 Titanium Ti-6Al-4V ELI |
| Diameters mm | 3.75 | 3.75 | 3.75 |
| Lengths<br>mm | 5, 7, 9, 11, 13 | 5, 7, 9, 12, 15 | 5, 7, 9, 11 |
| Implant / Abutment<br>connection | Internal Hex | Internal Hex | Internal Hex |
| Surface | ZircoSeal<br>[Surface is similar to PerioType<br>X-pert K123386] | CNC Machined | CNC Machined |
| Anatomical Site | Oral Cavity | Oral Cavity | Oral Cavity |

## 12 Substantial Equivalence

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Image /page/6/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 tooth or bone structure. To the right of the symbol is the company name, "OsteoReady," in a bold, blue font. Below the name is the tagline "Practical Implant Solutions" in a smaller, lighter font.

| Indication for Use | OsteoReady ® ZircoSeal® Dental Abutments are intended to be used with an endosseous implant to aid prosthetic rehabilitation in order to restore the patient's chewing function. OsteoReady® ZircoSeal® Abutments are compatible with DENTIN® Dental Implant System - Prestige Implant System diameters 3.75, 4.2, 5 & 6. | The AB Dental Devices implants are intended for surgical placement in the maxillary mandibular and/or arch to support crowns, bridges, or overdentures in edlentulous or partially edentulous patients. | IQ 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. IQ Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization | Provided non sterile prior to their use sterilize in an autoclave. | Provided non sterile prior to their use sterilize in an autoclave. | Provided non sterile prior to their use sterilize in an autoclave. |
| Use | Single use | Single use | Single use |

| Substantial Equivalent<br>Table<br>CHARACTERISTIC | Candidate<br>Anti Rotation Abutment with<br>ZircoSeal ® | REFERENCE PREDICATE DEVICE<br>P3* Abutment Anti rotation |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k | | K112440, K051719 |
| Company Name | OsteoReady LLC | A.B.Dental Devices Itd. |
| Device Design | Endosseous dental implant abutment | Endosseous dental implant abutment |
| Classification | Class II 872.3630<br>P.Code NHA | Class II 872.3630<br>P.Code NHA |
| Material | GR-5 Titanium Ti-6Al-4V ELI | GR-5 Titanium Ti-6Al-4V ELI |
| Diameters mm | 4.5 | 4.5 |
| Lengths<br>mm | 5, 7, 9, 11, 13 | 5, 7, 9, 12, 15 |
| Implant / Abutment connection | Internal Hex | Internal Hex |
| Surface | ZircoSeal [Surface is similar to PerioType X-<br>pert K123386] | CNC Machined Surface |
| Anatomical Site | Oral Cavity | Oral Cavity |
| Indication for Use | OsteoReady ® ZircoSeal® Dental<br>Abutments are intended to be used with<br>an endosseous implant to aid prosthetic<br>rehabilitation in order to restore the<br>patient's<br>chewing<br>function.<br>OsteoReady® ZircoSeal® Abutments are<br>compatible with DENTIN® Dental Implant<br>System - Prestige Implant System<br>diameters 3.75, 4.2, 5 & 6. | The AB Dental Devices implants<br>are<br>intended for surgical placement in the<br>maxillary mandibular and/or arch to<br>support crowns, bridges, or overdlentures<br>in edlentulous or partially edentulous<br>patients. |
| Sterilization | Provided non sterile prior to their use<br>sterilize in an autoclave. | Provided non sterile prior to their use<br>sterilize in an autoclave. |
| Use | Single use | Single use |

・

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Image /page/7/Picture/0 description: The image shows the logo for OsteoReady. The logo features a stylized blue icon on the left, resembling a series of concentric arcs. 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 font.

| Substantial Equivalent Table<br>CHARACTERISTIC | Candidate<br>Anti Rotation Straight Abutment with<br>ZircoSeal ® | PRIMARY PREDICATE DEVICE<br>PerioType X-pert, ZircoSeal® Abutments<br>NAS |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k | | K123386 |
| Company Name | OsteoReady LLC | Clinical House Europe Gmbh |
| Device Design | Endosseous dental implant abutment | Endosseous dental implant abutment |
| Classification | Class II 872.3630<br>P.Code NHA | Class II 872.3630<br>P.Code NHA |
| Material | GR-5 Titanium Ti-6Al-4V ELI | Titanium Grade 4 |
| Diameters mm | 4.5 | 4.2, 5.5 |
| Lengths<br>mm | Cuff height 1, 2, 3, 4 | Cuff height 1, 2, 3, 4 |
| Implant / Abutment connection | Internal Hex | Internal Hex |
| Surface | ZircoSeal | ZircoSeal |
| Anatomical Site | Oral Cavity | Oral Cavity |
| Indication for Use | OsteoReady ® ZircoSeal® Dental<br>Abutments are intended to be used with<br>an endosseous implant to aid prosthetic<br>rehabilitation in order to restore the<br>patient's chewing function.<br>OsteoReady® ZircoSeal® Abutments<br>are compatible with DENTIN® Dental<br>Implant System - Prestige Implant<br>System diameters 3.75, 4.2, 5 & 6. | The PerioType X-Pert Abutments are<br>straight and angled dental implant<br>abutments to be used in conjunction with<br>the PerioType X-Pert dental implant fixture<br>to aid in prosthetic rehabilitation. |
| Sterilization | Provided non sterile prior to their use<br>sterilize in an autoclave. | Provided non sterile prior to their use<br>sterilize in an autoclave. |
| Use | Single use | Single use |

#### Summary of Equivalence:

OsteoReady® ZircoSeal® Abutment System shares similarity to A.B.Dental Devices Itd. K112440, K051719; IQ Implants K130829; PerioType X-Pert K123386 in terms of intended use, indication for use, technological characteristics and performance.

The differences are that A.B.Dental Devices Itd. K112440, K051719; IQ Implants K130829; use CNC machined surface to their abutments while OsteoReady uses the ZircoSeal® surface treatment which is identical surface to its other predicate device the PerioType X-Pert K123386. In addition, PerioType X-Pert K123386 uses titanium grade 4 while OsteoReady uses titanium alloy as in similar to its other predicate devices A.B.Dental Devices Itd. K112440, K051719; IQ Implants K130829; The verbiage of the Indications for Use of the subject device is slightly different than that of the declared predicates; however, these slight differences in wording does not

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Image /page/8/Picture/0 description: The image contains the logo for OsteoReady, a company that provides practical implant solutions. The logo consists of a blue circular graphic on the left, resembling a stylized wave or ripple effect. To the right of the graphic is the company name "OsteoReady" in a bold, blue font. Below the name, in a smaller font, is the tagline "Practical Implant Solutions."

change the intended use of the subject device has compared to the declared predicate. As demonstrated by the substantial equivalent table, the differences raise no new safety or/and effectiveness issues, thus OsteoReady® ZircoSeal® Abutments System considered to be substantial equivalent to its predicate devices.

Risk Assessment was conducted with accordance to ISO 14971:2012 Medical devices -Application of risk management to medical devices Class II Special Controls Guidance Document.

Therefore, OsteoReady® ZircoSeal® Abutments system is considered to be substantially equivalent to its predicate devices.

Conclusion:

As verified by substantial equivalence, risk assessment and bench testing OsteoReady® ZircoSeal® Abutment System shares similarity with its predicate devices in terms of intended use, indication for use, raw material, technological characteristics and performance.

Thus OsteoReady® ZircoSeal® Abutment System is considered to be substantially equivalent to its predicate devices.