(160 days)
No
The summary describes a physical dental abutment made of titanium alloy with a zirconium nitride surface treatment. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device, OsteoReady® ZircoSeal® Dental Abutments, aids in prosthetic rehabilitation to restore chewing function. While it helps restore function, it is not described as treating or curing a disease or medical condition in the traditional sense of a therapeutic device. It serves as a structural component for dental prosthetics.
No
The device is an dental abutment intended to aid prosthetic rehabilitation and restore chewing function, not to diagnose a condition.
No
The device description clearly states that the device is a physical abutment made of titanium alloy with a surface treatment. It describes physical dimensions and materials, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aid prosthetic rehabilitation in order to restore the patient's chewing function" by being used with an endosseous implant. This is a mechanical function within the body.
- Device Description: The device is a dental abutment made of titanium alloy, designed to connect a dental implant to a prosthetic. This is a physical component for a surgical and restorative procedure.
- 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 treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) as a structural component of a dental restoration.
N/A
Intended Use / Indications 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;
Product codes
NHA
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.
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
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.
Key Metrics
Not Found
Predicate Device(s)
K123386, K112440, K051719, K130829
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
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.(b)
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.)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other.
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.
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 (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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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.
Page 1 of
| SECTION 4 - | Indication for Use Statement |
|---|---|
| 510(k) Number (if known): | |
| K151169 | |
| Device Name: | |
| OsteoReady® ZircoSeal® Abutments | |
| Indications for Use ( Describe ) | |
| Indications 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; | |
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 : 206-812-7727 | |||||
| Fax : 800-721-4907 | |||||
| 2 | Official Correspondent | Sterling Medical Registration | |||
| Contact Person | Daniela Levy - Regulatory Consultant | ||||
| 22817 Ventura blvd. | |||||
| Woodland Hills, CA 91364 | |||||
| Phone: 1-213-787-3027 | |||||
| Email: daniela@sterlingmedicalregistration.com | |||||
| 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
Equivalent Table
CHARACTERISTIC | Candidate
Slim Anti Rotation
Abutment with ZircoSeal ® | REFERENCE PREDICATE
DEVICE
P3 Anti rotation abutment | REFERENCE
PREDICATE DEVICE
Slim Straight Abutment |
|---------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------|---------------------------------------------------------|
| 510k | | K112440, K051719 | K130829 |
| Company Name | OsteoReady LLC | A.B.Dental Devices Itd. | IQ Implants Itd |
| Device Design | Endosseous dental implant
abutment | Endosseous dental implant
abutment | Endosseous dental implant
abutment |
| Classification | Class II 872.3630
P.Code NHA | Class II 872.3630
P.Code NHA | Class II 872.3630
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
mm | 5, 7, 9, 11, 13 | 5, 7, 9, 12, 15 | 5, 7, 9, 11 |
| Implant / Abutment
connection | Internal Hex | Internal Hex | Internal Hex |
| Surface | ZircoSeal
[Surface is similar to PerioType
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
Table
CHARACTERISTIC | Candidate
Anti Rotation Abutment with
ZircoSeal ® | REFERENCE PREDICATE DEVICE
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
P.Code NHA | Class II 872.3630
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
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-
pert K123386] | CNC Machined Surface |
| Anatomical Site | Oral Cavity | Oral Cavity |
| 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 overdlentures
in edlentulous or partially edentulous
patients. |
| Sterilization | 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 |
・
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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
CHARACTERISTIC | Candidate
Anti Rotation Straight Abutment with
ZircoSeal ® | PRIMARY PREDICATE DEVICE
PerioType X-pert, ZircoSeal® Abutments
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
P.Code NHA | Class II 872.3630
P.Code NHA |
| Material | GR-5 Titanium Ti-6Al-4V ELI | Titanium Grade 4 |
| Diameters mm | 4.5 | 4.2, 5.5 |
| Lengths
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
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 PerioType X-Pert Abutments are
straight and angled dental implant
abutments to be used in conjunction with
the PerioType X-Pert dental implant fixture
to aid in prosthetic rehabilitation. |
| Sterilization | 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 |
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
8
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.