(174 days)
Not Found
No
The summary describes a physical dental implant and its manufacturing process, with no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is intended to restore original dental function and aesthetic features, which are therapeutic benefits.
No
Explanation: The device is a dental implant designed to restore dental function and aesthetic features by providing support for prostheses, not to diagnose medical conditions.
No
The device is a physical dental implant made of titanium, fabricated using Direct Laser Metal Forming. It is surgically placed in bone and supports prostheses. This clearly indicates a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that TiXos dental implants are "permanent devices for single use only that are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches of the patient".
- Intended Use: The intended use is to "restore their original dental function and aesthetic features by providing support for fixed and/or removal prosthesis."
This device is a surgically implanted medical device, not a device used for testing samples outside of the body.
N/A
Intended Use / Indications for Use
TiXos dental implants are permanent devices for single use only that are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches of the patient in order to restore their original dental function and aesthetic features by providing support for fixed and/or removal prosthesis. TiXos dental implants can support single tooth, multiple tooth, or total prosthesis restorations and are compatible with the following dental abutments manufactured by Leader Italia that were previously cleared under K062931.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
Leader Italia's line of TiXos dental implants are titanium endosseous implants that are fabricated by a process called Direct Laser Metal Forming ("DLMF"). This fabrication process results in the production of implants with a porous surface characterized by open intercommunicating cavities and networks. The implant systems are intended to be placed in the bone of the mandibular and/or maxillary dental arches of the patient to provide support for their fixed and/or removal prosthesis, and to restore their original dental and/or masticatory function. TiXos dental implants are permanent devices for single use and can support single tooth, multiple tooth, or total prosthesis restorations. These implants are exclusively with Leader Italia's line of prosthetic abutments and surgical instruments. TiXos dental implants are gamma sterilized, have a five year shelf life, are submitted in two basic model configurations called Cylindrical and S-Type, and a number of different sizes and diameters as shown below.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular and/or maxillary dental arches
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Data - Bench Testing & Device Validations: As part of demonstrating the safety and effectiveness of TiXos dental implants and in showing substantial equivalence to its IMPLUS implants, Leader Italia submitted a number of its dental implants for fatigue testing in accordance with ISO 14801, Dentistry - Implants - Dynamic Fatigue Test for Endosseous Dental Implants, where their implants were tested in dry (i.e., air) environment. Testing was performed on the TiXos dental implants to simulate worst-case loading conditions and was compared to the predicate device and found it be similar.
Further, TiXos dental implants also underwent extensive validation activities for biocompatibility, cleaning, packaging, shelf-life and sterilization in accordance with Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments, and all applicable recognized FDA consensus standards for dental implants, including but not limited to, ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Test for in vitro Cytotoxicity.
Clinical Data: As part of demonstrating the safety and effectiveness of its TiXos dental implants, Leader Italia submitted a prospective summary report, and radiographic images, to the FDA that were part of its European clinical study and represent follow-up data for their implants at different time intervals after the implants were loaded with their prosthetic abutments. Results of this clinical information have been published in a number of peer reviewed scientific dental journals as shown below.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the word "LEADER" spelled out in individual boxes. Each letter is in a separate box, and the boxes are arranged in a row. The word is written in a simple, sans-serif font. The background of the boxes is white, and the letters are black.
5. 510(K) Summary
Submission Correspondent
Company Name:
Company Address:
Company Contact:
Country:
Phone:
Fax:
Submission Date:
Website:
Submission Sponsor
Company Name:
Company Address:
Country: Phone:
Fax:
:
Website:
Image /page/0/Picture/17 description: The image shows the logo for Emergo Group, which is displayed above a world map. The text "EMERGO GROUP" is in all caps. Below the logo and map is the text "K120797".
5 2012 SEP
Emergo Group, Inc.
611 West 5th Street Third Floor Austin, TX 78701
Stuart R. Goldman Senior Consultant project.management@emergogroup.com
USA
512.327.9997
512.327.9998
March 8, 2012
Leader Italia, Srl
Via Aquileja 43/B Ciniseilo Balsamo (MI) 20092
Italy
39 02 618651
39 02 61290676
1
Image /page/1/Picture/0 description: The image shows the word "LEADER" spelled out in individual boxes. Each letter is separated by a vertical line. The letters are in a sans-serif font and are all capitalized. The background of the boxes is white, and the letters are black.
Image /page/1/Picture/1 description: The image shows the logo for Emergo Group. The logo consists of the words "EMERGO GROUP" in a sans-serif font, with a stylized globe symbol in between the two words. A faded world map is in the background.
Device Classification
| Device Sponsor: | Leader Italia, Srl |
|---|---|
| Device Trade Name: | TiXos Implant System (dental implants) |
| Product Classification Name: | Implant, Endosseous, Root-Form |
| Product Code: | DZE |
| Regulation Number: | 872.3640 |
| Classification Panel: | Dental Devices |
| Regulatory Class: | Class 2 |
Predicate Device
IMPLUS Implant System (K062931) manufactured by Leader Italia, Srl
Indications for Use
TiXos dental implants are permanent devices for single use only that are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches of the patient in order to restore their original dental function and aesthetic features by providing support for fixed and/or removal prosthesis. TiXos dental implants can support single tooth, multiple tooth, or total prosthesis restorations and are compatible with the following dental abutments manufactured by Leader Italia that were previously cleared under K062931.
| ABUTMENT CODE | ABUTMENT NAME |
|---|---|
| Tixos Internal Hex Ø 3.3 | Platform Size (mm): 3.5 |
| 01ATI33 | Straight Abutment Ø 4.5 |
| 01ATIF33 | Frictioning Abutment Ø 4.5 |
| 01AS33 | Shoulder Abutment Ø 4.5 |
| 01ASF33 | Shoulder Frictioning Abutment Ø 4.5 |
| 01AP1533 | 15° Angled Abutment Ø 4.5 |
| 01AP601533 | 15° Angled Abutment Ø 6 |
| 01AP15F33 | 15° Angled Frictioning Abutment Ø 4.5 |
| 01AP2533 | 25° Angled Abutment Ø 4.5 |
| 01AP602533 | 25° Angled Abutment Ø 6 |
| 01AP25F33 | 25° Angled Frictioning Abutment Ø 4.5 |
| 01AB332, 01AB333 | |
| 01AB334, 01AB335 | Ball Abutment Ø 4.5 |
| 01ABA332, 01ABA333 | |
| 01ABA334, 01ABA335 | Ball Abutment with Antirotation Base Ø 4.5 |
| 01ATS331, 01ATS332 | Tissue Abutment Ø 4.5 for Screw- |
| Retained Denture | |
| 01AATI331A, | |
| 01AATI332A | Antirotation Abutment |
| Tixos Internal Hex Ø 3.75 | Platform Size (mm): 4 |
| 01ATIC4 | Straight Abutment Ø 4.5 |
| 01ATIC6 | Straight Abutment Ø 6 |
| ABUTMENT CODE | ABUTMENT NAME |
| Tixos Internal Hex Ø 4.5 | Platform Size (mm): 5 |
| 01ATI5 | Straight Abutment Ø 5 |
| 01ATIF5 | Frictioning Abutment Ø 5 |
| 01AP1560 | 15° Angled Abutment Ø 6 |
| 01AB502, 01AB503 | |
| 01AB504 | Ball Abutment Ø 5 |
| 01AATI451A | Antirotation Abutment |
| 01ATI5 | Straight Abutment Ø 5 |
| Tixos Internal Hex Ø 5.5 | Platform Size (mm): 6 |
| 01AB602, 01AB603 | |
| 01AB604 | Ball Abutment Ø 6 |
| 01ATI6055 | Straight Abutment Ø 6 |
| 01ATI60F55 | Frictioning Abutment Ø 6 |
| 01AATI551A | Antirotation Abutment |
| Tixos External Hex Ø 3.3/3.75 | Platform Size (mm): 4.1 |
| 01ATIX33 | Straight Abutment Ø 4.5 |
| 01ATI60X33 | Straight Abutment Ø 6 |
| 01ATIXF33 | Straight Frictioning Abutment Ø 4.5 |
| 01AXS33 | Shoulder Abutment Ø 4.5 |
| 01AXS6033 | Shoulder Abutment Ø 6 |
| 01AXSF33 | Shoulder Frictioning Abutment Ø 4.5 |
2
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| 01ATICF4 | Frictioning Abutment Ø 4.5 |
|---|---|
| 01ASC4 | Shoulder Abutment Ø 4.5 |
| 01ASC6 | Shoulder Abutment Ø 6 |
| 01ASCF4 | Shoulder Frictioning Abutment Ø 4.5 |
| 01APC1540 | 15° Angled Abutment Ø 4.5 |
| 01APC601540 | 15° Angled Abutment Ø 6 |
| 01APC2540 | 25° Angled Abutment Ø 4.5 |
| 01APC602540 | 25° Angled Abutment Ø 6 |
| 01APC15F40 | 15° Angled Frictioning Abutment Ø 4.5 |
| 01APC25F40 | 25° Angled Frictioning Abutment Ø 4.5 |
| 01ATIM4 | Multi-function Abutment |
| 01ABC452, 01ABC453 | Ball Abutment Ø 4.5 |
| 01ABC454, 01ABC455 | Ball Abutment with Antirotation Base |
| 01ABA402, 01ABA403 | |
| 01ABA404, 01ABA405 | Ø 4.5 |
| 01AC1A, 01AC2A | Antirotation Abutment |
| 01APX1533 | 15° Angled Abutment Ø 4.5 |
| 01APX2533 | 25° Angled Abutment Ø 4.5 |
| 01ABX332, 01ABX333 | Ball Abutment Ø 4.5 |
| 01ABX334, 01ABX335 | |
| 01ABXA2, 01ABXA3 | Ball Abutment with Antirotation Base |
| 01ABXA4, 01ABXA5 | |
| 01AATIX331A, | |
| 01AATIX332A | Antirotation Abutment |
| Tixos External Hex Ø 5 | Platform Size (mm): 4.1 |
| 01AATIX501A | Antirotation Abutment |
| 01ATIX5 | Straight Abutment Ø 5 |
| 01ATIXF5 | Straight Frictioning Abutment Ø 5 |
Device Description
Leader Italia's line of TiXos dental implants are titanium endosseous implants that are fabricated by a Eeader frails 3 line of 17xos detal Forming ("DLMF"). This fabrication process results in the production of process cance Direct asser wisee characterized by open intercommunicating cavities and networks. The implant with a porous surface only placed in the bone of the mandibular and/or maxillary dental implants are intended to be interest to be their fixed and/or removal prosthesis, and to restore their arches of the putient to provental and/or masticatory function. TiXos dental implants are permanent original devices for single use and can support single tooth, multiple tooth, or total prosthesis dental devices for single ass and our on on on on endexclusively with Leader Italia's line of restorations: These implants and surgical instruments. TiXos dental implants are gamma sterilized, have a five prostheticulabatinents and submit wo basic model configurations called Cylindrical and S-Type, and a number of different sizes and diameters as shown below.
| TiXos Implants | |
|---|---|
| Models & Sizes | |
| TiXos Cylindrical Line | |
| Internal Connection | Ø 3.3 mm / L 8, 10, 11.5, 13, 16 mm |
| Ø 3.75 mm / L 8, 10, 11.5, 13, 16 mm | |
| Ø 4.5 mm / L 8, 10, 11.5, 13, 16 mm | |
| Ø 5.5 mm / L 8, 10, 11.5, 13 mm | |
| External Connection - Long | Ø 3.3 mm / L 10, 11.5, 13, 16 mm |
| Ø 3.75 mm / L 8, 10, 11.5, 13, 16 mm | |
| Ø 5.0 mm / L 8, 10, 11.5, 13 mm | |
| TiXos S-Type Line | |
| S-Type | Ø 3.75 mm / L 10, 11.5, 13 mm |
| Ø 4.5 mm / L 10, 11.5, 13 mm |
3
Image /page/3/Picture/0 description: The image shows the word "LEADER" spelled out using individual letters. Each letter is printed in black ink on a white rectangular card. Vertical black lines separate each letter, creating distinct boxes for each character.
Image /page/3/Picture/1 description: The image shows the logo for Emergo Group. The logo consists of the words "EMERGO" and "GROUP" in a sans-serif font, with a stylized globe symbol in between. A faded world map is in the background.
Predicate Device Comparison
Aside from the slight differences in sizes (i.e., diameter and length) between TiXos and the predicate implants, TiXos implants are manufactured using Leader Italia's Direct Laser Metal Forming process as opposed to the more conventional machining and acid etching techniques the company uses to produce its IMPLUS implants.
Both TiXos and IMPLUS implants are single use, permanent dental devices that are surgically placed in either the mandibular and/or maxillary dental arches of the patient; both implants are cleaned, enckaged and gamma sterilized in identical manners; use the same abutments that have been designed and manufactured by Leader Italia, and have identical implant-to-abutment interface connections; and can be implanted using the same surgical instruments.
Some select properties and characteristics of the subject and predicate devices are compared side-byside as shown below.
| Substantial Equivalence Comparison
| Selected Properties Of IMPLUS vs. TiXos Dental Implants | ||
|---|---|---|
| Feature | Leader Italia | |
| IMPLUS Implants | Leader Italia | |
| TiXos Implants | ||
| 510(k): | K062931 | Pending |
| Product Code: | DZE | DZE |
| Regulation Number: | 872.3640 | 872.3640 |
| Regulation Name: | Implant, Endosseous, Root-Form | Implant, Endosseous, Root-Form |
| Implant Material: | Ti grade 4 | Ti-6Al-V4 |
| Raw Material Form: | Rod Stock | Powder |
| Implant Fabrication Method: | Traditional CNC Machining | Direct Laser Metal Forming |
| Surface Formed By: | Acid Etching | Direct Laser Metal Forming |
| Implant Geometries: | Various | Various |
| Designed For Prosthetic | ||
| Abutments: | Yes | Yes |
| Implant/abutment Interface: | Internal and External | Internal, External, and |
| Integrated Abutment | ||
| Implant Diameters (mm): | 3.3, 3.75, 4.5, 4.75, 5.0 | |
| 5.5, 5.75, 6 | 3.3, 3.75, | |
| 4.5, 5.0, 5.5 | ||
| Implant Lengths (mm): | 8, 10, 11.5, 13, 16, 20 | 8, 10, 11.5, 13, 16 |
| Single Use: | Yes | Yes |
| Sterile: | Yes | Yes |
| Intended Use: | Titanium endosseous implants to | |
| be surgically placed in the bone | ||
| of the mandibular and/or | ||
| maxillary dental arches in order | ||
| to provide support for fixed | Titanium endosseous implants to | |
| be surgically placed in the bone | ||
| of the mandibular and/or | ||
| maxillary dental arches in order | ||
| to provide support for fixed |
4
Image /page/4/Picture/0 description: The image shows the word "LEADER" spelled out in individual boxes. Each letter is separated by a vertical line. The letters are all capitalized and in a sans-serif font. The background of the boxes is white.
Image /page/4/Picture/1 description: The image shows the logo for Emergo Group. The logo consists of the words "EMERGO" and "GROUP" in a sans-serif font, with a stylized symbol in between. The symbol appears to be a stylized "E" within a circle. A faded world map is in the background.
| | and/or removal prosthesis to
restore the original aesthetic
features, dental and/or
masticatory function to the
patient after osseointegration
has taken place. | and/or removal prosthesis to
restore the original aesthetic
features, dental and/or
masticatory function to the
patient after osseointegration
has taken place. |
| -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Non-Clinical Data - Bench Testing & Device Validations
As part of demonstrating the safety and effectiveness of TiXos dental implants and in showing substantial equivalence to its IMPLUS implants, Leader Italia submitted a number of its dental implants for fatigue testing in accordance with ISO 14801, Dentistry - Implants - Dynamic Fatigue Test for Endosseous Dental Implants, where their implants were tested in dry (i.e., air) environment. Testing was performed on the TiXos dental implants to simulate worst-case loading conditions and was compared to the predicate device and found it be similar.
Further, TiXos dental implants also underwent extensive validation activities for biocompatibility, cleaning, packaging, shelf-life and sterilization in accordance with Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments, and all applicable recognized FDA consensus standards for dental implants, including but not limited to, ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Test for in vitro Cytotoxicity.
Clinical Data
As part of demonstrating the safety and effectiveness of its TiXos dental implants, Leader Italia submitted a prospective summary report, and radiographic images, to the FDA that were part of its European clinical study and represent follow-up data for their implants at different time intervals after the implants were loaded with their prosthetic abutments. Results of this clinical information have been published in a number of peer reviewed scientific dental journals as shown below.
| Tixos Implants | |
|---|---|
| Summary of In-Vivo Clinical Articles | |
| Title | Publication |
| Early Human Bone Response to Laser Metal Sintering Surface Topography: | |
| A Histological Report | Journal of Oral Implantology |
| Vol. XXXVI/No. Two, 2010 | |
| Influence of Direct Laser Fabrication Implant Topography on Type IV Bone: | |
| A Histomorphometric Study In Humans | Journal of Biomedical Materials |
| Research, Part A, 9 July, 2009 | |
| SEM and X-Ray Dispersive Spectrometry Evaluation of Direct Laser Metal | |
| Sintering Surface and Human Bone Interface: A Case Series | Lasers In Medical Science, 2011 |
| Single-Tooth Direct Laser Metal Forming (Dlmf) Titanium Implants: Results | |
| From A 1- Year Prospective Multicenter Study | Lasers in Medical Science |
| Report on a Screw on Sintered Titanium, Removed After Two Months of | |
| Osseointegration | The University of Insubria, Varese, |
| Italy - Department of Human | |
| Morphology, 2008 |
5
Image /page/5/Picture/0 description: The image shows the word "LEADER" spelled out using individual letter tiles. Each letter is printed in black ink on a white tile. Vertical black lines separate each letter, creating a distinct visual break between them. The tiles are arranged horizontally, forming the complete word.
Image /page/5/Picture/1 description: The image shows the logo for Emergo Group. The logo consists of the company name in capital letters, with a stylized globe symbol in the center. The logo is set against a faded map of the world.
| Prospective Clinical Evaluation of 201 Direct Laser Metal Forming Implants:
Results From a 1 Year Multicenter Study | Lasers in Medical Science, accepted
on February 2011 |
|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Dental implants from laser fusion of titanium microparticles: from research
to clinical applications | Journal of Osseointegration |
| Immediate Loading of Mandibular Overdentures Supported by Unsplinted
Direct Laser Metal-Forming Implants: Results From a 1-Year Prospective
Study | Journal of Periodontol |
Substantially Equivalence
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the new device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness compared to the predicate device.
It has been shown in this 510(k) submission that the differences between the TiXos and IMPLUS dental implants do not raise any questions regarding its safety and effectiveness. Leader Italia's TiXos Implant System, as designed and manufactured, is therefore determined to be substantially equivalent to their IMPLUS Implant System previously cleared under K062931.
6
Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle, emphasizing the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Leader Italia S.R.L. C/O Mr. Stuart R. Goldman Senior Consultant Emergo Group, Incorporated 611 West 5TH Street, Third Floor Austin, Texas 78701
Re: K120792
Trade/Device Name: TiXos Implant System (Dental Implants) Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 1, 2012 Received: August 3, 2012
Dear Mr. Goldman:
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.
SEP 5 2012
7
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 device-related 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For
Anthony D. Watson, B.S., M.S., M.B.A. · Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications For Use
510(k) Number (if known): 120792
TiXos dental implants are permanent devices for single use only that are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches of the patient in order to restore their m inc bental function and aesthetic features by providing support for fixed and/or removal prosthesis. onginal dental implants can support single tooth, multiple tooth, or total prosthesis restorations and are r noo deliter with the following dental abutments manufactured by Leader Italia that were previously cleared under K062931.
| ABUTMENT CODE | ABUTMENT NAME | ABUTMENT CODE | ABUTMENT NAME |
|---|---|---|---|
| Tixos Internal Hex Ø 3.3 | |||
| Platform Size (mm): 3.5 | Tixos Internal Hex Ø 4.5 | ||
| Platform Size (mm): 5 | |||
| 01ATI33 | Straight Abutment Ø 4.5 | 01ATIS | Straight Abutment Ø 5 |
| 01ATIF33 | Frictioning Abutment Ø 4.5 | 01ATIFS | Frictioning Abutment Ø 5 |
| 01AS33 | Shoulder Abutment Ø 4.5 | 01AP1560 | 15° Angled Abutment Ø 6 |
| 01ASF33 | Shoulder Frictioning Abutment Ø 4.5 | 01AB502, 01AB503 | |
| 01AB504 | Ball Abutment Ø 5 | ||
| 01AP1533 | 15° Angled Abutment Ø 4.5 | 01AATI451A | Antirotation Abutment |
| 01AP601533 | 15° Angled Abutment Ø 6 | 01ATIS | Straight Abutment Ø 5 |
| 01AP15F33 | 15° Angled Frictioning Abutment Ø 4.5 | Tixos Internal Hex Ø 5.5 | |
| Platform Size (mm): 6 | |||
| 01AP2533 | 25° Angled Abutment Ø 4.5 | 01AB602, 01AB603 | |
| 01AB604 | Ball Abutment Ø 6 | ||
| 01AP602533 | 25° Angled Abutment Ø 6 | ||
| 01AP25F33 | 25° Angled Frictioning Abutment Ø 4.5 | 01ATI6055 | Straight Abutment Ø 6 |
| 01AB332, 01AB333 | |||
| 01AB334, 01AB335 | Ball Abutment Ø 4.5 | 01ATI60F55 | Frictioning Abutment Ø 6 |
| 01ABA332, 01ABA333 | |||
| 01ABA334, 01ABA335 | Ball Abutment with Antirotation Base | ||
| Ø 4.5 | 01AATI551A | Antirotation Abutment | |
| 01ATS331, 01ATS332 | Tissue Abutment Ø 4.5 for Screw- | ||
| Retained Denture | Tixos External Hex Ø 3.3/3.75 | ||
| Platform Size (mm): 4.1 | |||
| 01AATI331A, | |||
| 01AATI332A | Antirotation Abutment | 01ATIX33 | Straight Abutment Ø 4.5 |
| Tixos Internal Hex Ø 3.75 | |||
| Platform Size (mm): 4 | 01ATI60X33 | Straight Abutment Ø 6 | |
| 01ATIC4 | Straight Abutment Ø 4.5 | 01ATIXF33 | Straight Frictioning Abutment Ø 4.5 |
| 01ATIC6 | Straight Abutment Ø 6 | 01AXS33 | Shoulder Abutment Ø 4.5 |
| 01ATICF4 | Frictioning Abutment Ø 4.5 | 01AXS6033 | Shoulder Abutment Ø 6 |
| 01ASC4 | Shoulder Abutment Ø 4.5 | 01AXSF33 | Shoulder Frictioning Abutment Ø 4.5 |
| 01ASC6 | Shoulder Abutment Ø 6 | 01APX1533 | 15° Angled Abutment Ø 4.5 |
| 01ASCF4 | Shoulder Frictioning Abutment Ø 4.5 | 01APX2533 | 25° Angled Abutment Ø 4.5 |
| 01APC1540 | 15° Angled Abutment Ø 4.5 | 01ABX332, 01ABX333 | |
| 01ABX334, 01ABX335 | Ball Abutment Ø 4.5 | ||
| 01APC601540 | 15° Angled Abutment Ø 6 | 01ABXA2, 01ABXA3 | |
| 01ABXA4, 01ABXA5 | Ball Abutment with Antirotation Base | ||
| 01APC2540 | 25° Angled Abutment Ø 4.5 | 01AATIX331A, | |
| 01AATIX332A | Antirotation Abutment | ||
| 01APC602540 | 25° Angled Abutment Ø 6 | Tixos External Hex Ø 5 | Platform Size (mm): 4.1 |
| 01APC15F40 | 15° Angled Frictioning Abutment Ø 4.5 | 01AATIX501A | Antirotation Abutment |
| 01APC25F40 | 25° Angled Frictioning Abutment Ø 4.5 | 01ATIX5 | Straight Abutment Ø 5 |
| 01ATIM4 | Multi-function Abutment | 01ATIXF5 | Straight Frictioning Abutment Ø 5 |
| 01ABC452, 01ABC453 | |||
| 01ABC454, 01ABC455 | Ball Abutment Ø 4.5 | ||
| 01ABA402, 01ABA403 | |||
| 01ABA404, 01ABA405 | Ball Abutment with Antirotation Base | ||
| Ø 4.5 |
Suer Reiser
gn-Om)
Anesthesiology, General Hospital
510(k) Number:
9
Over-The-Counter Use _
·
(21 CFR 801 Subpart C)
・
Prescription Use 区
AND/OR
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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