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.

Device Description

The proposed devices are threaded, root-form endosseous implants of various diameters and lengths and corresponding abutments. 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 6A1 4V. Instruments and accessories necessary to place implants and abutments also form part of the system.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the AVINENT Implant System. It describes the device, its intended use, a comparison with predicate devices, and concludes with a substantial equivalence determination. However, it does not contain acceptance criteria or a study proving the device meets acceptance criteria in the format typically associated with performance metrics like sensitivity, specificity, accuracy, or clinical endpoints.

Instead, this document focuses on demonstrating substantial equivalence to already legally marketed predicate devices based on:

Material composition: Titanium Grade 5 (TiAl6V4 ELI) and PEEK, consistent with predicate devices.
Form/Features: Root-form, tapered, microthread, self-tapping with hexagonal internal/external connections, mirroring features in predicate devices.
Dimensions: Diameters, lengths, and prosthetic connections are within the range of predicate devices.
Surface Treatment: BAS (Biomimetic Advanced Surface) which is described as shot-blasted and anodized to form a titanium oxide layer, compared to TiUnite® and RBT surfaces in predicates. The key is the functionality of promoting osseointegration.
Abutment Material: Titanium Grade 5 (TiAl6V4 ELI) and PEEK, aligning with predicate devices.
Implant/Abutment Connection: External Hex and Internal Hex, matching predicate devices.
Abutment forms/Features: Straight and angled up to 30°, similar to predicate devices.

The "study" that supports this submission is explicitly stated as non-clinical bench testing:

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 (fatigue) testing taking account of the level and duration of contact with the body, surface finish testing, packaging validation and sterilization process validation."

Therefore, the requested information elements related to clinical study design (sample size for test set, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set) are not present in this document, as the device's clearance was based on substantial equivalence through non-clinical bench testing.

Here's a summary of the available information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied by Predicate Comparison)	Reported Device Performance (AVINENT Implant System)
Material: Biocompatible, load-bearing material (e.g., Titanium Grade 5, Titanium CP Grade 4)	Titanium Grade 5 (TiAl6V4 ELI) for implants and abutments. PEEK also used for abutments.
Form/Features: Root-form, tapered, microthread, self-tapping, hexagonal internal/external connection (similar to predicate devices)	Root-form, tapered, microthread, self-tapping with hexagonal external connection (Coral Line) and root-form, microthread, self-tapping with hexagonal internal connection (Coral Line, Ocean Line)
Implant Diameters (Endosseous): Range typically 3.0 to 6.0 mm (as seen in predicates)	3.3 to 5.0 mm
Implant Lengths: Range typically 7.0 to 18.0 mm (as seen in predicates)	7.0 to 15.0 mm
Surface Treatment: Promotes osseointegration (e.g., TiUnite®, RBT)	BAS - Biomimetic Advanced Surface: shot-blasted and anodized to form titanium oxide layer on implant threads and collar. (Functionally equivalent to predicate surface treatments for promoting fixation).
Implant/Abutment Connection: Secure and stable (e.g., External Hex, Internal Hex, Internal Morse Taper)	External Hex and Internal Hex.
Abutment Forms/Features: Straight and angled options up to a certain degree (e.g., 15° to 30°)	Straight and angled up to 30°.
Mechanical Performance: Withstands foreseeable operating conditions, including fatigue testing (as per FDA guidance for dental implants)	Bench testing performed, specifically including mechanical performance (fatigue) testing. (No specific quantitative acceptance criteria or results are provided in the summary, just confirmation that it was done and showed "correct operation").
Surface Finish, Packaging, Sterilization: Validated to ensure safety and function	Surface finish testing, packaging validation, and sterilization process validation were performed. (No specific acceptance criteria or results are provided in the summary, just confirmation that it was done and showed "correct operation").

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not applicable. The submission is based on non-clinical bench testing and comparison to predicate devices, not a clinical test set.
Data Provenance: Non-clinical bench testing. No country of origin for clinical data is applicable. Retrospective or prospective study design is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Human expert ground truth is not relevant for this type of submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a dental implant, not an AI-powered diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable in the context of clinical "ground truth." The "ground truth" for demonstrating substantial equivalence rests on adherence to material standards, mechanical performance benchmarks, and functional similarity to predicate devices, verified through non-clinical testing.

8. The sample size for the training set:

Not applicable. There is no AI component or training set involved.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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K121873

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 2008181 SANTPEDORBARCELONASPAIN
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.

ProductFamily	Connection	Implant Platform	Implantdiameter	Implant length
DentalImplant-CoralLine	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

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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
DentalImplant-OceanLine	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.

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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:

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510(k) Premarket Notificat

AVINENT
Implant System

ection 5 – 510(k) Summar

SUMMARY OFCOMPARISONWITHPREDICATEDEVICE:	Proposed Device	EXTERNAL CONNECTION		INTERNAL CONNECTION	Predicate Devices
		Predicate Device		Proposed Device
Material	AVINENT ImplantSystemC.Ext.	K041661 NobelBiocareEndosseousImplants.	K050406 Nobel Speedy	AVINENT ImplantSystemC.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-tappingwith hexagonal externalconnection.	Straight or taperedimplant. Externalconnection system.	Tapered implant with apronounced apicaltaper. Externalconnection system.	Root-form, microthread,self-tapping withhexagonal internalconnection.	Antomically tapereddental implant body.Aggressive buttressthreads. Internalconnection system.	Small diameter (3.0mm)internal connectionsystem.
Diameterø prostheticconnection:	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
Diameterø 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 Treatmentto promote implantFixation.	BAS - BiomimeticAdvanced Surface: shot-blasted and anodized toform titanium oxide layeron implant threads andcollar.	TiUnite® titanium oxidelayer from implantthreads onto implantcollar.	TiUnite® titanium oxidelayer from implantthreads onto implantcollar.	BAS - BiomimeticAdvanced Surface:anodized to formtitanium oxide layer onimplant threads andcollar.	RBT - roughened (shot-blasted) or coated(hydroxylapatite)threaded surface,micro-machinedgrooves on implantcollar.	TiUnite® titanium oxidelayer from implant threadsonto 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 / AbutmentConnection	External Hex	External Hex	External Hex	Internal Hex	Internal Hex	Internal Morse Taper
Abutment forms /Features	Straight and angled upto 30°	Straight and angled upto 30°	Straight and angled upto 30°	Straight and angled upto 30°	Straight and angled upto 25°	Straight and angled upto 15°

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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.

Specific indications for small diameter (03.3 mm implants):

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.

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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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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

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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)

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'

Regulation Number and Section

§ 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.