(156 days)
No
The summary describes a traditional dental implant system and does not mention any AI or ML components or functionalities.
No
The device provides support for prosthetic devices (artificial teeth) to restore chewing function, which is a supportive and restorative function rather than directly treating a disease or condition.
No
Explanation: The device is a dental implant system used for surgical and restorative applications to provide support for prosthetic devices (artificial teeth) and restore chewing function. It is a treatment device, not a diagnostic one.
No
The device description explicitly lists physical components such as implants, abutments, screws, caps, and surgical instruments, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical and restorative application for supporting prosthetic devices in the jawbone to restore chewing function. This is a direct intervention on the patient's body.
- Device Description: The device components are physical implants, abutments, screws, and surgical instruments used in a surgical 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 samples, 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 (inside the body) as a physical implant.
N/A
Intended Use / Indications for Use
Aria Bio's 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. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The Aria Bio Dental Implant System consists of two stage endosseous form dental implants, hexagonal and conical implants and hexagonal and conical abutments; cover screws and healing caps; abutment systems and superstructures and surgical instruments.
The Aria Bio Dental Implant System includes:
Versatile model is a platform switched, tapered implant designed for use in any bone type and is offered with either a deep conical or Morse tapered hex connection. It is available in lengths of 8, 10, 11.5, 13 and 16 mm except for the 4.2 mm diameter which is available in 8, 10, 11.5, 13, 16, 18 and 20, and in diameters of 3.5, 3.75, 4.2, 4.5, 5 and 6 mm. The Versatile implants are constructed of Ti-6ALAV-ELI (Grade 23). Immediate model is a platform switched root-form implant design. The Immediate suitable for both immediate load applications and insertion into fresh extraction sockets and is offered with either a deep conical or Morse tapered hex connection. It is available in lengths of 8, 10, 11.5, 13, 16 mm except for the 3.5 diameter model which is available in 10, 11.5, 13, 16 mm and in diameters of 3.5, 3.75, 4.2, 4.5, 5 and 6 mm. The immediate implants are constructed of Ti-6AL4V-ELI (Grade 23).
Fixation model is a root form implant is appropriate for both immediate load applications and insertion into fresh extraction sockets. The Fixation is offered with a deep conical or prosthetic connection. The Fixation is available in lengths of 8.5, 10, 11.5, 13, 15, and 18 mm and in diameters of 3.5, 4.3, 5.0 and 6.0 mm. The Fixation implants are constructed of Ti-6AL4V-ELI (Grade 23).
Solution model is equipped with a specially designed, narrow, deep, conical connection and is designed for use in narrow bone volumes. The Solution5 is available in lengths of 10, 11.5, 13, 16 mm with diameter of 3.25 mm. The Solution2 is available with lengths of 8, 10, 11.5, 13, 16 mm and with a diameter of 3.25 mm. The Solution5 and Solution2 differ in that the Solution5 implants have an outer thread like the Immediate implant model, while the Solution2 implants have an outer thread like the Versatile implant model. The Solution implants are constructed of Ti-6AL4V-ELI (Grade 23).
Healing caps are available in 3 platform sizes: normal, narrow and wide and are made of Ti-6AL4V-ELI (Grade 23). The conical connection models are available in narrow, regular and wide platforms with lengths of 2, 3, 4, 5, 6, 7 mm and diameters of 3.0, 3.5 and 4.3 mm. The hex connection models are available in narrow emergence, regular platform with lengths of 2, 3, 4. 5. 6. 7 mm and a diameter of 3.75 mm and wide emergence regular platform with lengths of 3, 4, 5, and 6 mm and a diameter of 3.75 mm.
Temporary abutment is for immediate loading if appropriate and is made of Ti-6AL4V-ELI (Grade 23). It is provided with a plastic cap and is available in 3 hardness levels from the hardest to the softest. The Temporary abutment is available with a conical connection in narrow, regular and wide platforms all with lengths of 1, 2, 3, 4, 5. 6 and 7 mm and diameters of 3.0. 3.5 and 4.3 mm. It is also available with a hex connection regular platform with lengths of 1, 2, 3, 4, 5, 6, 7 mm and a diameter of 3.75 mm.
Temporary abutment plastic caps are for temporary use in conjunction with the temporary abutments for up to 30 days and are constructed of Delrin. They are supplied soft, medium and hard.
Anti Rotation abutments are straight titanium (Ti-6AL4V-ELI (Grade 23)) abutments with hex designed for permanent restoration. The abutments are supplied as regular non-shouldered straight abutments with lengths of 5, 7, 9, 12 and 15 mm with a narrow conical platform of 3.0 mm width, a regular conical platform of 3.5 mm width a regular hex platform of 3.75 mm width and a wide conical platform of 4.3 mm. As a narrow emergence non-shouldered straight abutment with lengths of 5, 7 and 9 mm with a narrow conical platform of 3.0 mm width, a regular conical platform of 3.5 mm width a regular hex platform of 3.75 mm width and a wide conical platform of 4.3 mm. As a wide emergence non shouldered straight abutment with lengths of 9 and 12 mm with a narrow conical platform of 3.0 mm width, a regular conical platform of 3.5 mm width a regular hex platform of 3.75 mm width and a wide conical platform of 4.3 mm.
15° and 25° angular abutment are made of Ti-6AL4V-ELI (Grade 23). 15° abutments are supplied as a conical connection narrow platform with a width of 3.0 mm and lengths of 9, 11 and 13 mm, a conical connection regular platform with a width of 3.5 mm and lengths of 9, 11 and 13 mm and a width of 3.75 mm with a length of 9 mm, a conical connection wide platform with a width of 4.3 mm and lengths of 9, 11 and 13 mm, a hex connection regular platform with a width of 3.75 mm and a length of 9 and 11 mm. 25° abutments are supplied as a conical connection narrow platform with a width of 3.0 mm and lengths of 9, 11 and 13 mm, a conical connection regular platform with a width of 4.3 mm and lengths of 9, 11 and 13 mm, a conical connection wide platform with a width of 3.5 mm and lengths of 9, 11 and 13 mm and , a hex connection regular platform with a width of 3.75 mm and lengths of 9, 11 and 13 mm. 15° and 25° narrow emergence abutments are supplied as a conical connection narrow platform with a width of 3.0 mm and length of 9.0 mm, as a conical connection regular platform with a width of 3.5 mm and length of 9.0 mm, as a conical connection wide platform with a width of 4.3 mm and length of 9.0 mm and as a hex connection regular platform with a width of 3.75 mm and length of 9.0 mm. Anatomic Straight Abutment are constructed of Ti-6ALAV-ELI (Grade 23). All have a length of 7.5mm and shoulder heights of 1, 2 and 3 mm. They are available in the following configurations: Conical connection, narrow platform 3.0 mm width, Conical connection, regular platform 3.5 mm width, Conical connection, wide platform 4.3 mm width, Hex connection, regular platform 3.75 mm width, Wide emergence, conical connection, narrow platform width 3.0 mm, Wide emergence, conical connection, regular platform width 3.5 mm, Wide emergence, conical connection, wide platform width 4.3 mm, Wide emergence, hex connection, wide platform width 4.3 mm
15°, 25° and 30° Angled Anatomic Abutment with Shoulder, all have a length of 7.5 mm and are constructed of Ti-6AL4V-ELI (Grade 23). They all have shoulder heights of 1, 2 and 3 mm and are available as conical connection, narrow platform width 3.0 mm, conical connection, regular platform width 3.5 mm, conical connection, wide platform width 4.3 mm, hex connection, regular platform width 3.75 mm. Straight Adaptor are all constructed of Ti-6AL4V-ELI (Grade 23) and are supplied in lengths of 1, 2, 3, 4, 5 and 6 mm in the following models: conical connection, narrow platform diameter 3.0 mm, conical connection, regular platform diameter 3.5 mm, conical connection, wide platform diameter 4.3 mm, hex connection, regular platform diameter 3.75 mm.
Casting Sleeves for Straight Adaptor are available in gold and titanium, all with width of 4.5mm and a length of 10.0 mm. Both gold and titanium are available in the following configurations: Gold sleeve casting adaptor, conical, narrow, Gold sleeve casting adaptor, conical, regular, Gold sleeve casting adaptor, conical, wide, Gold sleeve casting adaptor, hex, regular.
Ball Attachment Abutments are all constructed of Ti-6AL4V-ELI (Grade 23). All provided with lengths of 1, 2, 3, 4, 5 mm and in the following configurations: Conical connection, narrow platform 3.0 mm diameter, Conical connection, regular platform 3.5 mm diameter, Conical connection, wide platform 4.3 mm diameter , Hex connection, regular platform 3.75 mm diameter.
Multi-Unit Abutment are all constructed of Ti-6AL4V-ELI (Grade 23) and are supplied with lengths of 1, 2, 3 and 4 mm. The following configurations are available in both narrow and wide platforms and in hex regular platform: Straight, Conical Connection 18°, Conical Connection 30°, Narrow and Wide Platform.
Cover Screw are all constructed of Ti-6AL4V-ELI (Grade 23) and are supplied with a conical connection as narrow, regular and wide and with a hex connection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
upper or lower jaw
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of performance tests and evaluations were performed to demonstrate that Aria Bio's Dental Implant System does not raise any new issues that may affect its substantial equivalency with its predicate devices. These evaluations include fatigue (ISO 14801), surface analysis by SEM/EDS and XPS, biocompatibility in accordance with ISO 10993-1, sterilization validation (ISO 11137-2, AAMI TIR 33, ISO 17665-1) and shelf life validation (ISO 11607-1) in order to assure maintaining of SAL 10° along the shelf life.
All results are supporting Aria Bio's labeling claims in order to establish substantial equivalency.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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).
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§ 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.
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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 features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 11, 2016
AriaBio International, Inc. % Tali Hazan Regulatory Consultant Talmed, Ltd. Ramot Naftali, Upper Galilee Ramot Naftali, 13830 ISRAEL
Re: K152555
Trade/Device Name: Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: January 10, 2016 Received: January 13, 2016
Dear Tali Hazan:
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.
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
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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 -
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152555
Device Name Dental Implant System
Aria Bio's 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. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |||
|---|---|---|---|---|
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | ||||
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | ||||
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | ||||
| The burden time for this collection of information is estimated to average 79 hours per response, including the | ||||
| time to review instructions, search existing data sources, gather and maintain the data needed and complete |
and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Type of Use (Select one or both, as applicable)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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Image /page/3/Picture/1 description: The image shows the logo for Aria Bio. The logo has the word "ARIA" in blue, with a green line underneath it. Below the line is the word "BIO" in blue. Underneath the word "BIO" are the words "implant science" in gray.
510(k) Summary for Aria Bio's Dental Implant and Abutments
1. Date Prepared: 07 February 2016
2. 510(k) Owner Name:
Aria Bio International, Inc. 2999 Overland Avenue, Suite 118, Los Angeles, California 90064 USA Phone: 855-373-1614; Fax 310-730-6241; Email: info@ariabio.com
Contact person:
Ms. Tali Hazan - RA Consultant Phone: +972-(0)50-5292-304 Fax: +972-(0)722448981 Email: tali.hazan@talmed.co.il
3. Device Name and Classification:
Common/Usual Name: Dental Implant System Proprietary/Trade name: Dental Implant System (Implants model names: Fixation, Versatile, Immediate, Solution2, Solution5) Classification: Aria Bio Dental Implants and Abutments have been classified as Class II devices under the following classification names:
| Regulation Description | Product Code | 21 CFR Ref. | Panel |
|---|---|---|---|
| Endosseous dental implant | Primary: DZE | ||
| Secondary: NHA | 872.3640 | DAGRID, | |
| Dental |
Aria Bio International, Inc., 2999 Overland Avenue, Suite 118, Los Angeles, California 90064 USA Phone: 855-373-1614 • Fax 310-730-6241 • Email: info@ariabio.com • www.ariabio.com
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Image /page/4/Picture/0 description: The image shows the logo for Aria Bio. The logo has the word "ARIA" in large, bold, red letters above a green line. Below the green line is the word "BIO" in large, bold, blue letters. Below the word "BIO" is the phrase "implant science" in small, light gray letters.
4. Predicate Devices:
Aria Bio's Dental Implants and Abutments are substantially equivalent to the following Predicate Devices:
- 4.1 Primary Predicate Device: AB Dental Implants (by AB Dental Ltd) cleared under K132125; regulation number 872.3640 (Endosseous Dental Implant), product code: DZE (primary) and NHA (secondary).
- 4.2 Reference Predicate Device: Alpha-Bio Tec Ltd Dental Implant System cleared under K063364; regulation number 872.3640 (Endosseous Dental Implant), product code: DZE.
5. Intended Use/Indications for Use:
Aria Bio's 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. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
6. Device Description:
The Aria Bio Dental Implant System consists of two stage endosseous form dental implants, hexagonal and conical implants and hexagonal and conical abutments; cover screws and healing caps; abutment systems and superstructures and surgical instruments.
The Aria Bio Dental Implant System includes:
Versatile model is a platform switched, tapered implant designed for use in any bone type and is offered with either a deep conical or Morse tapered hex connection. It is available in lengths of 8, 10, 11.5, 13 and 16 mm except for the 4.2 mm diameter which is available in 8, 10, 11.5, 13, 16, 18 and 20, and in diameters of 3.5, 3.75, 4.2, 4.5, 5 and 6 mm. The Versatile implants are constructed of Ti-6ALAV-ELI (Grade 23). Immediate model is a platform switched root-form implant design. The Immediate suitable for both immediate load applications and insertion into fresh extraction sockets and is offered with either a deep conical or Morse tapered hex connection. It is available in lengths of 8, 10, 11.5, 13, 16 mm except for the 3.5 diameter model which is available in 10, 11.5, 13, 16 mm and in diameters of 3.5, 3.75, 4.2, 4.5, 5 and 6 mm. The immediate implants are constructed of Ti-6AL4V-ELI (Grade 23).
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Image /page/5/Picture/0 description: The image shows the logo for Aria Bio. The logo has the word "ARIA" stacked on top of the word "BIO". There is a green line separating the two words. Underneath the word "BIO" is the phrase "implant science" in a smaller font.
Fixation model is a root form implant is appropriate for both immediate load applications and insertion into fresh extraction sockets. The Fixation is offered with a deep conical or prosthetic connection. The Fixation is available in lengths of 8.5, 10, 11.5, 13, 15, and 18 mm and in diameters of 3.5, 4.3, 5.0 and 6.0 mm. The Fixation implants are constructed of Ti-6AL4V-ELI (Grade 23).
Solution model is equipped with a specially designed, narrow, deep, conical connection and is designed for use in narrow bone volumes. The Solution5 is available in lengths of 10, 11.5, 13, 16 mm with diameter of 3.25 mm. The Solution2 is available with lengths of 8, 10, 11.5, 13, 16 mm and with a diameter of 3.25 mm. The Solution5 and Solution2 differ in that the Solution5 implants have an outer thread like the Immediate implant model, while the Solution2 implants have an outer thread like the Versatile implant model. The Solution implants are constructed of Ti-6AL4V-ELI (Grade 23).
Healing caps are available in 3 platform sizes: normal, narrow and wide and are made of Ti-6AL4V-ELI (Grade 23). The conical connection models are available in narrow, regular and wide platforms with lengths of 2, 3, 4, 5, 6, 7 mm and diameters of 3.0, 3.5 and 4.3 mm. The hex connection models are available in narrow emergence, regular platform with lengths of 2, 3, 4. 5. 6. 7 mm and a diameter of 3.75 mm and wide emergence regular platform with lengths of 3, 4, 5, and 6 mm and a diameter of 3.75 mm.
Temporary abutment is for immediate loading if appropriate and is made of Ti-6AL4V-ELI (Grade 23). It is provided with a plastic cap and is available in 3 hardness levels from the hardest to the softest. The Temporary abutment is available with a conical connection in narrow, regular and wide platforms all with lengths of 1, 2, 3, 4, 5. 6 and 7 mm and diameters of 3.0. 3.5 and 4.3 mm. It is also available with a hex connection regular platform with lengths of 1, 2, 3, 4, 5, 6, 7 mm and a diameter of 3.75 mm.
Temporary abutment plastic caps are for temporary use in conjunction with the temporary abutments for up to 30 days and are constructed of Delrin. They are supplied soft, medium and hard.
Anti Rotation abutments are straight titanium (Ti-6AL4V-ELI (Grade 23)) abutments with hex designed for permanent restoration. The abutments are supplied as regular non-shouldered straight abutments with lengths of 5, 7, 9, 12 and 15 mm with a narrow conical platform of 3.0 mm width, a regular conical platform of 3.5 mm width a regular hex platform of 3.75 mm width and a wide conical platform of 4.3 mm. As a narrow emergence non-shouldered straight abutment with lengths of 5, 7 and 9 mm with a narrow conical platform of 3.0 mm width, a regular conical platform of 3.5 mm width a regular hex platform of 3.75 mm width and a wide conical platform of 4.3 mm. As a wide emergence non shouldered straight abutment with lengths of 9
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Image /page/6/Picture/0 description: The image shows the logo for Aria Bio. The logo has the word "ARIA" in blue, with a green line underneath it. Below that is the word "BIO" in blue. Underneath that is the phrase "implant science" in a smaller, light gray font.
and 12 mm with a narrow conical platform of 3.0 mm width, a regular conical platform of 3.5 mm width a regular hex platform of 3.75 mm width and a wide conical platform of 4.3 mm.
15° and 25° angular abutment are made of Ti-6AL4V-ELI (Grade 23). 15° abutments are supplied as a conical connection narrow platform with a width of 3.0 mm and lengths of 9, 11 and 13 mm, a conical connection regular platform with a width of 3.5 mm and lengths of 9, 11 and 13 mm and a width of 3.75 mm with a length of 9 mm, a conical connection wide platform with a width of 4.3 mm and lengths of 9, 11 and 13 mm, a hex connection regular platform with a width of 3.75 mm and a length of 9 and 11 mm. 25° abutments are supplied as a conical connection narrow platform with a width of 3.0 mm and lengths of 9, 11 and 13 mm, a conical connection regular platform with a width of 4.3 mm and lengths of 9, 11 and 13 mm, a conical connection wide platform with a width of 3.5 mm and lengths of 9, 11 and 13 mm and , a hex connection regular platform with a width of 3.75 mm and lengths of 9, 11 and 13 mm. 15° and 25° narrow emergence abutments are supplied as a conical connection narrow platform with a width of 3.0 mm and length of 9.0 mm, as a conical connection regular platform with a width of 3.5 mm and length of 9.0 mm, as a conical connection wide platform with a width of 4.3 mm and length of 9.0 mm and as a hex connection regular platform with a width of 3.75 mm and length of 9.0 mm. Anatomic Straight Abutment are constructed of Ti-6ALAV-ELI (Grade 23). All
have a length of 7.5mm and shoulder heights of 1, 2 and 3 mm. They are available in the following configurations: Conical connection, narrow platform 3.0 mm width, Conical connection, regular platform 3.5 mm width, Conical connection, wide platform 4.3 mm width, Hex connection, regular platform 3.75 mm width, Wide emergence, conical connection, narrow platform width 3.0 mm, Wide emergence, conical connection, regular platform width 3.5 mm, Wide emergence, conical connection, wide platform width 4.3 mm, Wide emergence, hex connection, wide platform width 4.3 mm
15°, 25° and 30° Angled Anatomic Abutment with Shoulder, all have a length of 7.5 mm and are constructed of Ti-6AL4V-ELI (Grade 23). They all have shoulder heights of 1, 2 and 3 mm and are available as conical connection, narrow platform width 3.0 mm, conical connection, regular platform width 3.5 mm, conical connection, wide platform width 4.3 mm, hex connection, regular platform width 3.75 mm. Straight Adaptor are all constructed of Ti-6AL4V-ELI (Grade 23) and are supplied in lengths of 1, 2, 3, 4, 5 and 6 mm in the following models: conical connection, narrow platform diameter 3.0 mm, conical connection, regular platform diameter 3.5 mm, conical connection, wide platform diameter 4.3 mm, hex connection, regular platform diameter 3.75 mm.
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Image /page/7/Picture/0 description: The image shows the logo for Aria Bio. The logo has the word "ARIA" stacked on top of the word "BIO". There is a green line separating the two words. Below the word "BIO" are the words "implant science" in a smaller font.
Casting Sleeves for Straight Adaptor are available in gold and titanium, all with width of 4.5mm and a length of 10.0 mm. Both gold and titanium are available in the following configurations: Gold sleeve casting adaptor, conical, narrow, Gold sleeve casting adaptor, conical, regular, Gold sleeve casting adaptor, conical, wide, Gold sleeve casting adaptor, hex, regular.
Ball Attachment Abutments are all constructed of Ti-6AL4V-ELI (Grade 23). All provided with lengths of 1, 2, 3, 4, 5 mm and in the following configurations: Conical connection, narrow platform 3.0 mm diameter, Conical connection, regular platform 3.5 mm diameter, Conical connection, wide platform 4.3 mm diameter , Hex connection, regular platform 3.75 mm diameter.
Multi-Unit Abutment are all constructed of Ti-6AL4V-ELI (Grade 23) and are supplied with lengths of 1, 2, 3 and 4 mm. The following configurations are available in both narrow and wide platforms and in hex regular platform: Straight, Conical Connection 18°, Conical Connection 30°, Narrow and Wide Platform.
Cover Screw are all constructed of Ti-6AL4V-ELI (Grade 23) and are supplied with a conical connection as narrow, regular and wide and with a hex connection.
7. Substantial Equivalence:
The proposed Aria Bio Dental Implant System has similar indications for use, technological characteristics, mode of operation and, performance specification as the above identified predicate devices. The proposed device utilizes similar intended use as the predicates and is placed using the same methodology as all of the selected predicate devices. Both the proposed and predicate devices function in the same manner providing support for prosthetic devices in the upper or lower jaw, having similar range of dimensions and basic shape. The specific indications for use for the current device and two predicate devices are shown in the following table:
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Image /page/8/Picture/0 description: The image shows the logo for Aria Bio. The logo has the word "ARIA" in large blue font with a green line underneath. Below that is the word "BIO" in a similar blue font. Underneath that is the phrase "implant science" in a smaller gray font.
| 510(k) Number | K063364 (Reference PD) | K132125 (Primary PD) | K152555 (Proposed) |
|---|---|---|---|
| Device | Alpha-Bio Tec Dental | ||
| Implant System | A.B. Dental Devices Dental | ||
| Implants System | Aria Bio Dental | ||
| Implant System | |||
| Indications for | |||
| Use | The Alpha-Bio 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. The | |||
| Alpha-Bio Dental | |||
| Implant System® | |||
| is indicated also for | |||
| immediate loading when | |||
| good primary stability | |||
| is achieved and with | |||
| appropriate occlusal | |||
| loading. | A.B.Dental Devices 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. A.B. Dental | |||
| Implants System is indicated also | |||
| for immediate loading when | |||
| good primary stability is | |||
| achieved and with appropriate | |||
| occlusal loading. | |||
| Two Stage Implants: | |||
| 12,15,16131. | |||
| One Stage: 16, 16b, 168. | |||
| One Stage & One-Piece 3.0 mm | |||
| diameter implants: 16, 168, | |||
| 16131, are intended for | |||
| placement at the mandibular | |||
| central and lateral incisors and | |||
| maxillary and lateral incisors. | |||
| Indicated also for denture | |||
| stabilization using multiple | |||
| implants. One stage & One-Piece | |||
| 2.4 mm diameter implants for | |||
| temporary use or long term use: | |||
| 16, 16b, permit immediate splint | |||
| stability and long term fixation of | |||
| new or existing crown, bridge | |||
| and prosthesis. P1 4 Angulated | |||
| Abutment Adapter is to be used | |||
| with implant diameter 4.2mm | |||
| and higher. | Aria Bio's 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. The | |||
| Dental Implant System | |||
| is indicated also for | |||
| immediate loading | |||
| when good primary | |||
| stability is achieved | |||
| with appropriate | |||
| occlusal loading. |
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Image /page/9/Picture/0 description: The image shows the logo for Aria Bio. The logo has the word "ARIA" in blue with a green line underneath it. Below that is the word "BIO" in blue. Underneath that is the phrase "implant science" in a smaller, light gray font.
Differences that were identified were addressed as follows:
Implants differences -
With the exception of the surface treatment the Aria Bio implants are similar as the two predicate implants. The predicate devices are treated with Calcium Fosfat-Hydroxyapatite while the Aria Bio implants are treated with HA blasting/Double acid etching. The slight difference in the surface treatment methods is not likely to affect the Titanium biocompatibility since both methods are valid and acceptable within the dental industry and biocompatibility was demonstrated by Aria Bio. Aria Bio products' list also do not include one-piece (one-stage) implant within this submission.
Abutments –
The difference between the Aria Bio abutments and the predicate abutments are in the dimensions offered. These difference are displayed in the following table (Abutments not shown do not differe from the predicate:
| Product Description | Aria Bio Product | Predicate Devices: | ||
|---|---|---|---|---|
| Diameter | ||||
| (mm) | Length (mm) | Diameter (mm) | Length (mm) | |
| AlphaBio K#063364 | ||||
| Healing abutment, Narrow | ||||
| Platform, Conical | 3.0 | 2, 3, 4, 5, 6, 7 | 3.2 | 3,5,7 |
| Healing abutment, Regular | ||||
| Platform, Conical | 3.5 | 2, 3, 4, 5, 6, 7 | 3.6 | 3,5,7 |
| Healing abutment, Wide | ||||
| Platform Conical | 4.3 | 2, 3, 4, 5, 6, 7 | 3.8 | 3,5,7 |
| 5.0 | 3,5,7 | |||
| AB Dental K#132125 | ||||
| Temporary Abutment, Narrow | ||||
| Platform, Conical | 3.0 | 1, 2, 3, 4 ,5, 6 ,7 | 3.75 | 1, 2, 3, 4 ,5, 6 ,7 |
| Temporary Abutment, | ||||
| Regular Platform, Conical | 3.5 | 1, 2, 3, 4 ,5, 6 ,7 | 3.75 | 1, 2, 3, 4 ,5, 6 ,7 |
| Temporary Abutment, Wide | ||||
| Platform, Conical | 4.3 | 1, 2, 3, 4 ,5, 6 ,7 | 3.75 | 1, 2, 3, 4 ,5, 6 ,7 |
| Temporary Abutment, | ||||
| Regular Platform, Hex | 3.75 | 1, 2, 3, 4 ,5, 6 ,7 | 3.75 | 1, 2, 3, 4 ,5, 6 ,7 |
| AB Dental K#132125 | ||||
| Anti-Rotation Abutment, | ||||
| Regular Non-Shouldered | ||||
| Straight, Narrow, conical | 3.0 | 5, 7, 9, 12, 15 | 3.75 | 5, 7, 9, 12, 15 |
| Anti-Rotation Abutment, | ||||
| Regular Non-Shouldered | ||||
| Straight, Regular, conical | 3.5 | 5, 7, 9, 12, 15 | 3.75 | 5,7,9 |
| Product Description | Aria Bio Product | Predicate Devices: | ||
| Diameter | ||||
| (mm) | Length (mm) | Diameter (mm) | Length (mm) | |
| Anti-Rotation Abutment, | ||||
| Regular Non-Shouldered | ||||
| Straight, Wide, conical | 4.3 | 5, 7, 9, 12, 15 | 3.75 | 7,9 |
| Anti-Rotation Abutment, | ||||
| Narrow Emergence Non- | ||||
| Shouldered Straight, Narrow, | ||||
| Conical | 3.0 | 5,7,9 | 3.75 | 5, 7, 9, 12, 15 |
| Anti-Rotation Abutment, | ||||
| Narrow Emergence Non- | ||||
| Shouldered Straight, Regular, | ||||
| Conical | 3.5 | 5,7,9 | 3.75 | 5,7,9 |
| Anti-Rotation Abutment, | ||||
| Narrow Emergence Non- | ||||
| Shouldered Straight, Wide, | ||||
| conical | 4.3 | 5,7,9 | 3.75 | 7,9 |
| Anti-Rotation Abutment Wide | ||||
| Emergence Non-Shouldered | ||||
| Straight Abutment, Narrow, | ||||
| Conical | 3.0 | 9, 12 | 3.75 | 5, 7, 9, 12, 15 |
| Anti-Rotation Abutment Wide | ||||
| Emergence Non-Shouldered | ||||
| Straight, Regular, conical | 3.5 | 9,12 | 3.75 | 5,7,9 |
| Anti-Rotation Abutment Wide | ||||
| Emergence Non-Shouldered | ||||
| Straight, Wide, conical | 4.3 | 9,12 | 3.75 | 7,9 |
| Anti-Rotation Abutment, | ||||
| Regular Non-Shouldered | ||||
| Straight, Regular, Hex | 3.75 | 5, 7, 9, 12, 15 | 3.75 | 5, 7, 9, 12, 15 |
| Anti-Rotation Abutment, | ||||
| Narrow Emergence Non- | ||||
| Shouldered Straight, Regular, | ||||
| Hex | 3.75 | 5,7,9 | 3.75 | 5,7,9 |
| Anti-Rotation Abutment, | ||||
| Wide Emergence Non- | ||||
| Shouldered Straight, Regular, | ||||
| Hex | 3.75 | 9, 12 | 3.75 | 7,9 |
| AB Dental K#132125 | ||||
| 15° Angled Anatomic | ||||
| Abutment with Shoulder, | ||||
| Conical Connection, Narrow | ||||
| Platform | 3.0 | 1, 2, 3 | 3.75 | 1, 2, 3 |
| Product Description | Aria Bio Product | Predicate Devices: | ||
| Diameter | ||||
| (mm) | Length (mm) | Diameter (mm) | Length (mm) | |
| 15° Angled Anatomic | ||||
| Abutment with Shoulder, | ||||
| Conical Connection, Regular | ||||
| Platform | 3.5 | 1, 2, 3 | 3.75 | 1, 2, 3 |
| 15° Angled Anatomic | ||||
| Abutment with Shoulder, | ||||
| Conical Connection, Wide | ||||
| Platform | 4.3 | 1, 2, 3 | 3.75 | 1, 2, 3 |
| 25° Angled Anatomic | ||||
| Abutment with Shoulder, | ||||
| Conical Connection, Narrow | ||||
| Platform | 3.0 | 1, 2, 3 | 3.75 | 1, 2, 3 |
| 30° Angled Anatomic | ||||
| Abutment with Shoulder, | ||||
| Conical Connection, Narrow | ||||
| Platform | 3.0 | 1 | 3.75 | 1, 2, 3 |
| 25° Angled Anatomic | ||||
| Abutment with Shoulder, | ||||
| Conical Connection, Regular | ||||
| Platform | 3.5 | 1, 2, 3 | 3.75 | 1, 2, 3 |
| 25° Angled Anatomic | ||||
| Abutment with Shoulder, | ||||
| Conical Connection, Wide | ||||
| Platform | 4.3 | 1, 2, 3 | 3.75 | 1, 2, 3 |
| AB Dental K#132125 | ||||
| Straight Adaptor, Conical | ||||
| Connection, Narrow Platform | 3 | 1, 2, 3, 4, 5 | 3.75 | 1, 2, 3, 4, 5 |
| Straight Adaptor, Conical | ||||
| Connection, Regular Platform | 3.5 | 1, 2, 3, 4, 5 | 3.75 | 1, 2, 3, 4, 5 |
| Straight Adaptor, Conical | ||||
| Connection, Wide Platform | 4.3 | 1, 2, 3, 4, 5 | 3.75 | 1, 2, 3, 4, 5 |
| Straight Adaptor,Hex | ||||
| Connection, Regular Platform | 3.75 | 1, 2, 3, 4, 5 | 3.75 | 1, 2, 3, 4, 5 |
| AB Dental K#132125 | ||||
| Gold Sleeve Casting Adaptor, | ||||
| Conical, Narrow | 4.5 | 10 | 4.5 | 10 |
| Gold Sleeve Casting Adaptor, | ||||
| Conical, Regular | 4.5 | 10 | 4.5 | 10 |
| Gold Sleeve Casting Adaptor, | ||||
| Conical. Wide | 4.5 | 10 | 4.5 | 10 |
| Product Description | Aria Bio Product | Predicate Devices: | ||
| Diameter | ||||
| (mm) | Length (mm) | Diameter (mm) | Length (mm) | |
| Titanium Sleeve Casting | ||||
| Adaptor, Conical, Narrow | 4.5 | 10 | 4.5 | 10 |
| Titanium Sleeve Casting | ||||
| Adaptor, Conical, Regular | 4.5 | 10 | 4.5 | 10 |
| Titanium Sleeve Casting | ||||
| Adaptor, Conical, Wide | 4.5 | 10 | 4.5 | 10 |
| AlphaBio K#063364 | ||||
| Multi-Unit Abutment: | ||||
| Multi-Unit Abutment Straight | ||||
| Adaptor, Conical Connection, | ||||
| Narrow Platform | 1, 2, 3, 4 | 1.6, 2.5, 3.5, 4.5 | ||
| (Regular platform) | ||||
| Multi-Unit Abutment 18°, | ||||
| Conical Connection, Narrow | ||||
| Platform | 1, 2, 3, 4 | 2.5, 3.5 (Regular | ||
| platform) | ||||
| Multi-Unit Abutment 30°, | ||||
| Conical Connection, Narrow | ||||
| Platform | 1, 2, 3, 4 | 3.5, 4.5 (Regular | ||
| platform) | ||||
| Multi-Unit Abutment Straight | ||||
| Adaptor, Conical Connection, | ||||
| Regular Platform | 1, 2, 3, 4 | 1.6, 2.5, 3.5, 4.5 | ||
| (Regular platform) | ||||
| Multi-Unit Abutment 18°, | ||||
| Conical Connection, Regular | ||||
| Platform | 1, 2, 3, 4 | 2.5, 3.5 (Regular | ||
| platform) | ||||
| Multi-Unit Abutment 30°, | ||||
| Conical Connection, Regular | ||||
| Platform | 1, 2, 3, 4 | 3.5, 4.5 (Regular | ||
| platform) | ||||
| Multi-Unit Abutment Straight | ||||
| Adaptor, Conical Connection, | ||||
| Wide Platform | 1, 2, 3, 4 | 1.6, 2.5, 3.5, 4.5 | ||
| (Regular platform) | ||||
| Multi-Unit Abutment 18°, | ||||
| Conical Connection, Wide | ||||
| Platform | 1, 2, 3, 4 | 2.5, 3.5 (Regular | ||
| platform) | ||||
| Multi-Unit Abutment 30°, | ||||
| Conical Connection, Wide | ||||
| Platform | 1, 2, 3, 4 | 3.5, 4.5 (Regular | ||
| platform) | ||||
| Multi-Unit Abutment Straight | ||||
| Adaptor, Hex Connection, | ||||
| Regular Platform | 1, 2, 3, 4 | 1.6, 2.5, 3.5, 4.5 | ||
| (Regular platform) | ||||
| Multi-Unit Abutment 18°, Hex | ||||
| Connection, Regular Platform | 1, 2, 3, 4 | 2.5, 3.5 (Regular | ||
| platform) | ||||
| Product Description | Aria Bio Product | Predicate Devices: | ||
| Diameter (mm) | Length (mm) | Diameter (mm) | Length (mm) | |
| Multi-Unit Abutment 30°, Hex Connection, Regular Platform | 1, 2, 3, 4 | 3.5, 4.5 (Regular platform) | ||
| AB Dental K#132125 | ||||
| Ball Attachment Abutment Conical, Regular Platform | 3.5 | 1, 2, 3, 4, 5, 6 | 4.1 | 1, 2, 3, 4, 5, 6 |
| Ball Attachment Abutment Conical, Wide Platform | 4.3 | 1, 2, 3, 4, 5, 6 | 4.1 | 1, 2, 3, 4, 5, 6 |
| Ball Attachment Abutment Hex, Regular Platform | 3.75 | 1, 2, 3, 4, 5, 6 | 4.1 | 1, 2, 3, 4, 5, 6 |
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Image /page/10/Picture/0 description: The image shows the logo for Aria Bio. The logo has the word "ARIA" in a large font, with a green line underneath it. Below the green line is the word "BIO" in a large blue font. Underneath the word "BIO" is the phrase "implant science" in a smaller, light gray font.
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Image /page/11/Picture/0 description: The image shows the logo for Aria Bio. The logo has the word "ARIA" in a large font, with a green line underneath it. Below the green line is the word "BIO" in a large blue font. Underneath the word "BIO" is the phrase "implant science" in a smaller, light gray font.
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Image /page/12/Picture/0 description: The image shows the logo for Aria Bio. The logo has the word "ARIA" on top in blue, with a green line underneath. Below that is the word "BIO" in a larger blue font. Underneath that is the phrase "implant science" in a smaller grey font.
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As can be shown in the comparison table, all the abutments (Aria Bio Dental, Alpha-Bio, AB Dental), consist of many variations which are basically very similar to each other. Any differences between the dimensions of the predicates and the predicate abutments fall well within the dimensions of abutments widely used in the dental field. One abutment angulation of Aria Bio Angled Anatomic Abutment 30° exceeds the predicate maximal angle 25°, yet this difference was evaluated through performance data (fatigue) with successful results. Therefore it was concluded that the dimensional differences do not affect the device substantial equivalency.
In the light of the above, we believe that the overall evaluation of similarities and differences between our device and the selected predicate devices, showed that substantial equivalency of our device with its predicate devices was demonstrated.
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Image /page/14/Picture/0 description: The image shows the logo for Aria Bio. The logo has the word "ARIA" stacked on top of the word "BIO". There is a green line separating the two words. Below the word "BIO" is the phrase "implant science" in a smaller, light gray font.
8. Performance Testing:
A series of performance tests and evaluations were performed to demonstrate that Aria Bio's Dental Implant System does not raise any new issues that may affect its substantial equivalency with its predicate devices. These evaluations include fatigue (ISO 14801), surface analysis by SEM/EDS and XPS, biocompatibility in accordance with ISO 10993-1, sterilization validation (ISO 11137-2, AAMI TIR 33, ISO 17665-1) and shelf life validation (ISO 11607-1) in order to assure maintaining of SAL 10° along the shelf life.
All results are supporting Aria Bio's labeling claims in order to establish substantial equivalency.
9. Summary and Conclusion:
We believe that Aria Bio Dental Implants products, which are the subject of this 510(k) submission, are substantially equivalent to the predicate devices cited above. The device constitutes a reliable medical device, meeting all declared requirements of its intended use and the device does not introduce new risks to patients when used as intended.