(532 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the dental implant system, with no mention of AI or ML capabilities.
Yes
The device is intended for oral endosseous implantation to functionally and esthetically rehabilitate patients, restore chewing function, and serve as anchorage for dental prosthetic restorations, which are all therapeutic purposes.
No
The device is a dental implant system designed for oral endosseous implantation and rehabilitation, serving to provide anchorage for prosthetic restorations. It is a treatment device, not a diagnostic one.
No
The device description explicitly states the proposed devices are threaded, root-form endosseous implants and corresponding abutments, which are physical hardware components made of titanium alloy.
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 device for oral endosseous implantation to restore chewing function and provide anchorage for dental prosthetic restorations. This is a surgical and prosthetic device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The device is described as threaded, root-form endosseous implants and corresponding abutments made of titanium alloy. This is consistent with a medical device for implantation, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
The device is a medical device intended for surgical implantation and prosthetic support.
N/A
Intended Use / Indications for Use
The AVINENT dental implant system is for oral endosseous implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients.
AVINENT implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations. Implants are intended for immediate loading on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function if the requirements detailed in the surgical manual are satisfied.
Specific indications for small diameter (Ø3.3 mm implants):
Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in maxillary lateral incisors or mandibular central and lateral incisors.
The implant system serves as anchorage for dental prosthetic restorations. Implants are placed in the bone of the upper or lower jaw. Abutments are placed into the dental implant to provide support for the prosthetic reconstruction including abutments for cemented restorations to achieve better esthetics, Abutments can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The proposed devices are threaded, root-form endosseous implants of various diameters and lengths and corresponding abutments.
Product Family: Dental Implant-Coral Line
Connection: External Hexagon and Internal Hexagon
Implant Platform: 3.5, 4.1, 5.1
Implant diameter: 3.3, 3.8, 4.0, 4.2, 4.8
Implant length: 7, 8.5, 10, 11.5, 13, 15
Product Family: Dental Implant-Ocean Line
Connection: External Hexagon and Internal Hexagon
Implant Platform: 3.5, 4.1
Implant diameter: 3.5, 4.0, 4.5, 5.0
Implant length: 7, 8.5, 10, 11.5, 13, 15
Abutment Types:
Healing abutment: 0 degrees
Cemented-Straight abutment: 0 degrees
Cemented-Angled abutment: 17 degrees
Temporary abutment: 0 degrees
Gold cylinder abutment: 0 degrees
Transepithelial abutment: 0 degrees
Transepithelial angled abutment: 30 degrees
Implants are titanium alloy 6Al 4V, feature internal and external hex implant to abutment connection options and are available with modified surfaces (TO2 layer) to promote improved osseointegration. Implant abutments are also titanium alloy 6Al 4V. Instruments and accessories necessary to place implants and abutments also form part of the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower jaw
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)
Bench testing was performed to determine conformance to performance specifications and requirements, specifically including mechanical performance (fatigue) testing taking account of the level and duration of contact with the body, surface finish testing, packaging validation and sterilization process validation. The testing showed correct operation of the device as per its intended use based on FDA Document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
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.
K073268, K102436, K041661, K050406
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
DEC 1 1 2013
AVINENT" Implant System
510(k) Premarket Notification
Section 5 - 510(k) Summary
| DATE OF SUBMISSION: | 2013-07-08 |
|---|---|
| SUBMITTER NAME: | AVINENT Implant System, S.L. |
| SUBMITTER ADDRESS: | Pol. Ind. Santa Anna, Apartat 20 |
| 08181 SANTPEDOR | |
| BARCELONA | |
| SPAIN | |
| CONTACT: | Anna Cortina Caixach |
| TELEPHONE: | +34 902 38 38 48 |
| Fax: | +34 93 827 38 73 |
| e-mail: | annacortina@avinent.com |
| DEVICE TRADE NAME: | AVINENT Implant System |
| COMMON NAME: | Root-form Endosseous Dental Implant |
| CLASSIFICATION NAME: | Root-form Endosseous Dental Implant (21 CFR 872.3640) |
| PREDICATE DEVICE(S): | Biohorizons (K073268) |
| NobelActive 3.0 (K102436) | |
| Nobel Biocare Endosseous Implants (K041661) | |
| NobelSpeedy (K050406) |
DEVICE DESCRIPTION:
The proposed devices are threaded, root-form endosseous implants of various diameters and lengths and corresponding abutments. The following is a list of the diameter / length combinations of the implant body, dental abutment type and maximum available angulation for each specific type of abutment.
| Product
Family | Connection | Implant Platform | Implant
diameter | Implant length |
|---------------------------------|------------------|------------------|---------------------|---------------------|
| Dental
Implant-Coral
Line | External Hexagon | 3.5 | 3.3 | 10,11.5,13 |
| | | 4.1 | 3.3 | 10,11.5,13,15 |
| | | | 3.8 | 7,8.5,10,11.5,13,15 |
| | | | 4.0 | 7,8.5,10,11.5,13,15 |
| | | | 4.2 | 7,8.5,10,11.5,13,15 |
| | | | 4.8 | 7,8.5,10,11.5,13 |
| | | 5.1 | 4.8 | 7,8.5,10,11.5,13 |
| | Internal Hexagon | 3.5 | 3.3 | 10,11.5,13,15 |
| | | 4.1 | 3.3 | 10,11.5,13,15 |
1
AVINENT Implant System
510(k) Premarket Notification
.
| 3.8 | 7,8.5,10,11.5,13,15 | |||
|---|---|---|---|---|
| 4.0 | 7,8.5,10,11.5,13,15 | |||
| 4.2 | 7,8.5,10,11.5,13,15 | |||
| 4.8 | 7,8.5,10,11.5,13 | |||
| Dental | ||||
| Implant-Ocean | ||||
| Line | External Hexagon | 3.5 | 3.5 | 10,11.5,13,15 |
| 4.1 | 4.0 | 7,8.5,10,11.5,13,15 | ||
| 4.5 | 7,8.5,10,11.5,13,15 | |||
| 5.0 | 7,8.5,10,11.5,13 | |||
| Internal Hexagon | 3.5 | 3.5 | 10,11.5,13,15 | |
| 4.1 | 4.0 | 7,8.5,10,11.5,13,15 | ||
| 4.5 | 7,8.5,10,11.5,13,15 | |||
| 5.0 | 7,8.5,10,11.5,13 |
Section 5 - 510(k) Summary
| Abutment Type | Maximum Abutment Angulation |
|---|---|
| Healing abutment | 0 degrees |
| Cemented-Straight abutment | 0 degrees |
| Cemented-Angled abutment | 17 degrees |
| Temporary abutment | 0 degrees |
| Gold cylinder abutment | 0 degrees |
| Transepithelial abutment | 0 degrees |
| Transepithelial angled abutment | 30 degrees |
Implants are titanium alloy 6Al 4V, feature internal and external hex implant to abutment connection options and are available with modified surfaces (TO2 layer) to promote improved osseointegration.
2
AVINENT Implant System
510(k) Premarket Notification
Section 5 - 510(k) Summary
Implant abutments are also titanium alloy 6A1 4V. Initial primary stablility of the implant when placed in the bone and implant osseointegration are essential to ensure implant success. Furthermore, the mechanical resistance of the implant-abutment connection is essential to ensure correct long-term functional performance of the dental restoration.Instruments and accessories necessary to place implants and abutments also form part of the system. These concepts are the basis upon which the implant system design characteristics and functional performance are established.
SUMMARY OF COMPARISON WITH PREDICATE DEVICE:
In the establishment of substantial equivalence, the AVINENT implant system is compared with the following previously cleared devices:
- Biohorizons (K073268) י
- NobelActive 3.0(K102436) -
- Nobel Biocare Endosseous Implants (K041661) •
- NobelSpeedy (K050406) -
Comparison of the proposed devices with the predicate devices is summarized in the following table:
3
510(k) Premarket Notificat
AVINENT
Implant System
ection 5 – 510(k) Summar
| SUMMARY OF
COMPARISON
WITH
PREDICATE
| DEVICE: | Proposed Device | EXTERNAL CONNECTION | INTERNAL CONNECTION | Predicate Devices | ||
|---|---|---|---|---|---|---|
| Predicate Device | Proposed Device | |||||
| Material | AVINENT Implant | |||||
| SystemC.Ext. | K041661 Nobel | |||||
| BiocareEndosseous | ||||||
| Implants. | K050406 Nobel Speedy | AVINENT Implant | ||||
| SystemC.Int. | K073268Biohorizons | K102436 Nobel Active 3.0 | ||||
| Titanium Grade 5 | ||||||
| (TIAI6V4 ELI) | Titanium CP Grade 4 | Titanium CP Grade 4 | Titanium Grade 5 | |||
| (TiAl6V4 ELI) | Titanium Grade 5 | |||||
| (TIAI6V4 ELI) | Titanium CP Grade 4 | |||||
| Form / Features | Root-form, tapered, | |||||
| microthread, self-tapping | ||||||
| with hexagonal external | ||||||
| connection. | Straight or tapered | |||||
| implant. External | ||||||
| connection system. | Tapered implant with a | |||||
| pronounced apical | ||||||
| taper. External | ||||||
| connection system. | Root-form, microthread, | |||||
| self-tapping with | ||||||
| hexagonal internal | ||||||
| connection. | Antomically tapered | |||||
| dental implant body. | ||||||
| Aggressive buttress | ||||||
| threads. Internal | ||||||
| connection system. | Small diameter (3.0mm) | |||||
| internal connection | ||||||
| system. | ||||||
| Diameter | ||||||
| ø prosthetic | ||||||
| connection: | 3.5 to 5.1 mm | 3.5 to 6.0 mm | 3.5 to 6.0 mm | 3.5 to 5.1 mm | 3.5 to 6.0 mm | 3.0 mm |
| Diameter | ||||||
| ø endosseous: | 3.3 to 5.0 mm | 3.3 to 6.0 mm | 3.3 to 6.0 mm | 3.3 to 5.0 mm | 3.5 to 6.0 mm | 3.0 mm |
| Range of lengths | 7.0 to 15.0 mm | 7.0 to 18.0 mm | 7.0 to 18.0 mm | 7.0 to 15.0 mm | 9mm, 10.5 mm, 12 mm, | |
| 15 mm. | 10.0 to 15 mm | |||||
| Surface Treatment | ||||||
| to promote implant | ||||||
| Fixation. | BAS - Biomimetic | |||||
| Advanced Surface: shot- | ||||||
| blasted and anodized to | ||||||
| form titanium oxide layer | ||||||
| on implant threads and | ||||||
| collar. | TiUnite® titanium oxide | |||||
| layer from implant | ||||||
| threads onto implant | ||||||
| collar. | TiUnite® titanium oxide | |||||
| layer from implant | ||||||
| threads onto implant | ||||||
| collar. | BAS - Biomimetic | |||||
| Advanced Surface: | ||||||
| anodized to form | ||||||
| titanium oxide layer on | ||||||
| implant threads and | ||||||
| collar. | RBT - roughened (shot- | |||||
| blasted) or coated | ||||||
| (hydroxylapatite) | ||||||
| threaded surface, | ||||||
| micro-machined | ||||||
| grooves on implant | ||||||
| collar. | TiUnite® titanium oxide | |||||
| layer from implant threads | ||||||
| onto implant collar. | ||||||
| Abutment Material | Titanium Grade 5 | |||||
| (TIAI6V4 ELI) and PEEK | Titanium Grade 5 | |||||
| (TIAI6V4 ELI) | Titanium Grade 5 | |||||
| (TIAI6V4 ELI) | Titanium Grade 5 | |||||
| (TiAl6V4 ELI) and PEEK | Titanium Grade 5 | |||||
| (TiAl6V4 ELI) and PEEK | Titanium Grade 5 | |||||
| (TIAI6V4 ELI) | ||||||
| Implant / Abutment | ||||||
| Connection | External Hex | External Hex | External Hex | Internal Hex | Internal Hex | Internal Morse Taper |
| Abutment forms / | ||||||
| Features | Straight and angled up | |||||
| to 30° | Straight and angled up | |||||
| to 30° | Straight and angled up | |||||
| to 30° | Straight and angled up | |||||
| to 30° | Straight and angled up | |||||
| to 25° | Straight and angled up | |||||
| to 15° |
4
Section 5 - 510(k) Summary
INTENDED USE:
As established in the Indications for Use Statement:
The AVINENT dental implant system is for oral endosseous implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients.
AVINENT implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations.
Implants are intended for immediate loading on single-tooth and/or multiple tooth applicationswhen good primary stability is achieved and with appropriate occlusal loading, to restore chewing function if the requirements detailed in the surgical manual are satisfied.
Specific indications for small diameter (03.3 mm implants):
Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in maxillary lateral incisors or mandibular central and lateral incisors.
The implant system serves as anchorage for dental prosthetic restorations. Implants are placed in the bone of the upper or lower jaw. Abutments are placed into the dental implant to provide support for the prosthetic reconstruction including abutments for cemented restorations to achieve better esthetics, Abutments can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.
SUMMARY DISCUSSION OF NON-CLINICAL DATA:
The proposed device has been subject to bench testing to determine conformance to performance specifications and requirements taking account of its intended use as a dental implant system and following all indications set out in FDA Document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
Bench testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use, specifically including mechanical performance (faligue) testing taking account of the level and duration of contact with the body. surface finish testing, packaging validation and sterilization process validation.
SUMMARY DISCUSSION OF CLINICAL DATA:
Non-clinical test data are submitted to support this premarket notification and to establish the decision concerning adequate safety and performance of the predicate device.
CONCLUSIONS:
We believe the intended use, the indications for use and performance of the AVINENT implant system is the same as the intended use, indications for use and performance of the predicate devices. We also believe that the AVINENT implant system does not suppose any new or increased risk compared with the predicate devices. Based on the information included in this submission, we conclude that the AVINENT implant system is substantially equivalent to the listed legally marketed predicate devices.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring. MD 20993-0002
December 11, 2013
Avinent Implant System, S.L. Ms. Anna Cortina Regulatory Affairs/R&D Manager POL. IND. Santa Anna. APARTAT 20 Santpedor. Barcelona 08251 SPAIN
Re: K121873
Trade/Device Name: Avinent Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: November 27, 2013 Received: December 2, 2013
Dear Ms. Cortina:
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. Iisting 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.
6
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 (OS) 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 Small Manufacturers. International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Image /page/6/Picture/8 description: The image shows the words "Kwame O. Ulmer-S" in a bold, sans-serif font. The word "Kwame" is on the top line, and the word "Ulmer-S" is on the bottom line. To the right of the words is a geometric design that looks like a triangle. The text is black, and the background is white.
for
Erin I. Keith, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
510(k) Premarket Notification
Section 4 - Indications for Use Statement
PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT (as required by ODE for all 510(k) received after Jan. 1, 1996)
K121873 510(k) Number:
TEN. Implant System
AVINENT IMPLANT SYSTEM Device Name:
Indications for Use:
The AVINENT dental implant system is for oral endosseous implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients.
A VINENT implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations. Inplants are intended for immediate loading on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function if the requirements detailed in the surgical manual are satisfied.
Specific indications for small diameter (Ø3.3 mm implants):
- Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in maxillary incisors or mandibular central and lateral incisors.
(Do not write below this line. Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (21 CFR 801 Subpart D)
OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
Mary S. Runner -S
Swaan R DOS IMA 2013.12.06
09:41:57-05'00'