S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Revolution Compact with a 6 mm length is intended for delayed loading only.

Device Description

The subject device includes six product lines (Revolution Compact, Micro-Mini Revolution, Strong SW HE, TryOn, Strong SW HI). Five of the product lines have an external hex implant/abutment connection (HE) and one has an internal hex implant/abutment connection (HI). Each product line includes implants with an acid-etched surface and abutments in multiple designs (healing, provisional, cemented, UCLA, overdenture, conical and mini).

Revolution implants (Revolution Compact, Micro-Mini Revolution) are cylindrical implants with apical cutting flutes and are placed with the Revolution Assembler mount. Strong SW HI are cvlindrical implants with apical cutting flutes and micro-threads on the collar. Strong SW HE has and external connection and Strong SW HI has an internal connection. TryOn implants with apical cutting flutes and a machined collar. Subject Device components are made of commercially pure titanium, titanium alloy or cobalt-chromium alloy. All subject device abutments have 0° angulation.

AI/ML Overview

This document is a 510(k) summary for the S.I.N. Dental Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use and technological characteristics, rather than presenting a performance study with acceptance criteria in the typical sense for a medical device with an AI/ML component.

Therefore, many of the requested details about acceptance criteria, study design, and AI performance metrics are not available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present acceptance criteria for a performance study in the way a clinical trial or AI validation study would. Instead, it demonstrates "substantial equivalence" of the S.I.N. Dental Implant System to existing predicate devices based on:

Indications for Use: The subject device's indications align with those of multiple predicate devices.
Technological Characteristics: Comparison of design (prosthesis attachment, restoration, implant/abutment interface, dimensions) and material composition (implant, surface, abutment, abutment screw) to predicate devices.
Non-clinical Testing Data: This includes validation of sterilization, biocompatibility, endotoxin testing, and shelf-life testing. These are regulatory compliance criteria, not performance metrics related to diagnostic or predictive accuracy.

Reported Device Performance (in terms of substantial equivalence):

Feature/Test	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Performance (Stated Equivalence/Compliance)
Indications for Use	Similar to predicate devices: placement in maxillary/mandibular arch for single/multi-unit restorations, immediate/delayed loading.	"Substantially equivalent in indications and design principles to the predicate devices." "Small differences... do not change the intended use."
Design Characteristics (e.g., diameters, lengths, connections)	Within common ranges and similar to predicate devices.	"Encompass the same range of physical dimensions."
Materials	Same or similar materials as predicate devices (e.g., CPTi Gr 4, Ti-6Al-4V, CoCr).	"Made of the same or similar materials."
Sterilization	SAL of 10^-6 according to ISO 11137-1, ISO 11137-2 (radiation); SAL of 10^-6 according to ISO 17665-1 and ISO 17665-2 (steam).	Validated to SAL of 10^-6 for both radiation and steam sterilization.
Biocompatibility	Acceptable biocompatibility according to ISO 10993-1.	Acceptable biocompatibility demonstrated by reference to K051859 and testing per ISO 10993-5 (cytotoxicity).
Endotoxin Testing	In accordance with FDA Guidance documents.	Limulus amebocyte lysate (LAL) endotoxin testing performed.
Shelf-Life Testing	Seal leaks according to ASTM F88/F88M, seal integrity according to ASTM F1929, accelerated age testing according to ASTM F1980.	Shelf-life testing including seal leak, seal integrity, and accelerated aging reported.
Surface Area Analysis	Substantially equivalent to a predicate.	Surface area analysis showed substantial equivalence to a predicate.

2. Sample Size for Test Set and Data Provenance

Sample Size: Not applicable. This document does not describe a performance study involving a "test set" of patient data for evaluating diagnostic or predictive accuracy. The testing mentioned is for non-clinical aspects (sterilization, biocompatibility, etc.), which would involve material samples or batches.
Data Provenance: Not applicable in the context of patient data. The "data" refers to non-clinical testing results.

3. Number of Experts for Ground Truth and Their Qualifications

Not applicable. This document pertains to the substantial equivalence of a physical dental implant system and does not involve AI/ML or a ground truth established by experts for diagnostic performance.

4. Adjudication Method

Not applicable. There is no "adjudication method" described as it relates to expert consensus for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document explicitly states: "No clinical data were included in this submission." An MRMC study would fall under clinical effectiveness.

6. Standalone (Algorithm Only) Performance Study

No. The device is a physical dental implant system, not a software algorithm.

7. Type of Ground Truth Used

Not applicable. Not relevant for this type of device submission. The "truth" here relates to the physical and material properties meeting regulatory standards and being substantially equivalent to legally marketed devices, verified through laboratory testing and predicate comparisons.

8. Sample Size for the Training Set

Not applicable. There is no "training set" as this device is not an AI/ML product.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no "ground truth for a training set" as this device is not an AI/ML product.

Summary

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S.I.N. - Sistema De Implante Nacional S.A. % Linda Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

November 21, 2017

Re: K170398

Trade/Device Name: S.I.N. Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: October 23, 2017 Received: October 24, 2017

Dear Linda Schulz:

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.

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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 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mary S. Runner -S

for

Tina Kiang, Ph.D. Acting 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K170398

Device Name

S.I.N. Dental Implant System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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.

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510(k) Summary S.I.N. - Sistema de Implante Nacional S.A. S.I.N. Dental Implant System K170398

November 21, 2017

ADMINISTRATIVE INFORMATION

Manufacturer Name	S.I.N. - Sistema de Implante Nacional S.A.Avenida Vereador Abel Ferreira, 1100São Paulo, São Paulo03340-000 BrazilTelephone: +55-11-21693000 ext 3236
Official Contact	Dênis OliveiraQuality and Regulatory Manager
Representative/Consultant	Linda K. Schulz, BSDH, RDHFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone: +1 (858) 792-1235Fax: +1 (858) 792-1236Email: lschulz@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	S.I.N. Dental Implant System
Common Name	Dental implant
	Dental implant abutment
Classification Name	Implant, endosseous, root form
	Endosseous dental implant abutment
Classification Regulations	21 CFR 872.3640, Class II
Product Code	DZE, NHA
Classification Panel	Dental Products Panel
Reviewing Branch	Dental Devices Branch

PREDICATE DEVICE INFORMATION

Primary Predicate Sistema de Implante Nacional Dental Implant System K021859 Sistema de Implante Nacional, Ltda.

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Reference Predicates
K120414	OsseoSpeed™ Plus	Astra Tech AB
K072570	NobelActive Multi Unit Abutment	Nobel Biocare AB
K072363	BIOMET 3i NanoTite™ Dental Implants	Biomet 3i, Inc.
K092035	Bicon Implants with a 2.5mm Internal Connection	Bicon, L.L.C.
K101945	Neodent Implant System	JJGC Industria e Comercio de MateriaisDentarios SA

INDICATIONS FOR USE

DEVICE DESCRIPTION

Summary of Implant Sizes
	BodyDiameter(mm)	PlatformDiameter(mm)	Length(mm)
Revolution	4.0	4.1	7
Revolution Compact	4.0, 5.0	5.0	6
Strong SW HE	3.5	3.65	7, 8.5, 10, 11.5, 13, 15
	3.75, 4.0	4.1	7, 8.5, 10, 11.5, 13, 15
	4.5	4.5	8.5, 10, 11.5, 13, 15
	5.0	5.0	7, 8.5, 10, 11.5, 13, 15
TryOn	3.25	4.1	8.5, 10, 11.5, 13, 15
	3.75, 4.0	4.1	7, 8.5, 10, 11.5, 13, 15
	5.0	5.0	7, 8.5, 10, 11.5, 13, 15
Strong SW HI	3.8	3.8	8.5, 10, 11.5, 13, 15
	4.5	4.5	8.5, 10, 11.5, 13, 15
	5.0	5.0	8.5, 10, 11.5, 13, 15

y of Implant Sizes

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PERFORMANCE DATA

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: radiation sterilization validation to an SAL of 10° according to ISO 11137-1, ISO 11137-2; Steam sterilization validation to an SAL of 10° according to ISO 17665-1 and ISO 17665-2; biocompatibility evaluation according to ISO 10993-1 by reference to K051859 and biocompatibility testing according to ISO 10993-5 (cytotoxicity), demonstrating acceptable biocompatibility ; Limulus amebocyte lysate (LAL) endotoxin testing in accordance with FDA Guidance documents Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile; shelf life testing seal leaks according to ASTM F88/F88M, seal integrity testing according to ASTM F1929, accelerated age testing according to ASTM F1980, and surface area analysis showing substantial equivalence to a predicate.

No clinical data were included in this submission.

EQUIVALENCE TO MARKETED DEVICE

The subject device is substantially equivalent in indications and design principles to the predicate devices shown above. Below are summary tables comparing the Indications for Use and the technological characteristics of the subject device and the predicate devices.

Subject Device
K170398S.I.N Implant SystemSIN - Sistema de Implante NacionalS.A.	S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to providesupport for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N.Dental Implant System is intended for immediate loading when good primary stability is achieved and withappropriate occlusal loading. Revolution Compact with a 6 mm length is intended for delayed loading only.
Primary Predicate Device
K051859Sistema de Implante Nacional DentalImplant SystemSIN - Sistema de Implante Nacional,Ltda.	The Sistema de Implante Nacional Dental Implant System is intended to be surgically placed in the bone ofthe maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. Implants may beplaced immediately after tooth extraction or following bone healing. Restorations supported by two or moreSistema de Implante Nacional implants may be loaded immediately after implant placement if primaryimplant stability has been achieved.
Reference Predicate Devices
K120414OsseoSpeedTM PlusAstra Tech AB	Implants: The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in thefollowing situations and with the following clinical protocols:replacing single and multiple missing teeth in the mandible and maxilla, immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge, especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective, immediate loading in all indications, except in single tooth situations on implants shorter than 8 mm, or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate. The intended use for OsseoSpeedTM Plus 3.0S is limited to replacement of maxillary lateral incisors and mandibular incisors.Abutments: Astra Tech Implant System Plus abutments are intended to be used in conjunction with AstraTech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches toprovide support for crowns, bridges or overdentures.Atlantis Abutments: The AtlantisTM Abutment is intended for use with an endosseous implant to support aprosthetic device in a partially or completely edentulous; patient. It is intended for use to support single andmultiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained orfriction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.The AtlantisTM Crown Abutment in Zirconia is intended for use with an endosseous; implant to function as a
	substructure that also serves as the final restoration, in partially or completely edentulous; patients. Theprosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseousimplant.
K072570NobelActive Multi Unit AbutmentNobel Biocare AB	NobelActive Multi Unit Abutment is a pre-manufactured prosthetic component directlyconnected to the endosseous dental implant and intended for use as an aid in prostheticrehabilitation.

Comparison of Indications for Use Statements

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K072363BIOMET 3i NanoTite™ DentalImplantsBIOMET 3i, Incorporated	BIOMET 3i dental implants are intended for surgical placement in the upper or lower jaw to provide a meansfor prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiplesingle teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed orremovable bridgework, and to retain overdentures.BIOMET 3i NanoTite dental implants are intended for immediate function on single tooth and/or multipletooth applications when good primary stability is achieved, with appropriate occlusal loading, in order torestore chewing function.
K092035	The Bicon implant is designed for use in edentulous sites in the mandible or maxilla for support of a complete
Bicon Implants with a 2.5mm InternalConnection	denture prosthesis, a final or intermediate abutment for fixed bridgework or for partial dentures, or as a singletooth replacement.
Bicon, L.L.C.
K101945	The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw toprovide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with
Neodent Implant System	single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediatelywhen good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications
JJGC Industria e Comercio de MateriaisDentarios SA	may be rigidly splinted.

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Comparison of Technological Characteristics

	Subject Device	PrimaryPredicate Device	Reference Predicate Devices
		K051859	K120414	K072570	K072363	K092035	K101945
	S.I.N. ImplantSystem	Sistema de ImplanteNacionalDental Implant System	OsseoSpeed™ Plus	NobelActive MultiUnit Abutment	BIOMET 3iNanoTite™Dental Implants	Bicon Implants witha 2.5mm InternalConnection	Neodent Implant System
	S.I.N. - Sistemade ImplanteNacional S.A.	S.I.N. - Sistema deImplante Nacional,Ltda.	Astra Tech AB	Nobel Biocare AB	BIOMET 3i, Inc.	Bicon, L.L.C.	JJGC Industria eComercio de MateriaisDentarios SA
DESIGN
Prosthesis Attachment	Screw-retainedCement-retained	Screw-retainedCement-retained	Screw-retainedCement-retained	Screw-retained	Screw-retainedCement-retained	Screw-retainedCement-retained	Screw-retainedCement-retained
Restoration	Single-unitMulti-unit	Single-unitMulti-unit	Single-unitMulti-unit	Multi-unit	Single-unitMulti-unit	Single-unitMulti-unit	Single-unitMulti-unit
Implant/AbutmentInterface	ExternalInternal	ExternalInternal	Internal	Internal	ExternalInternal	Internal	Internal
Implant Diameter, mm	3.25 - 5.0	3.25 - 6.3	3.0 - 5.4	NA	3.25 - 6.0	4.0 - 4.5	3.3 - 5.0
Implant Length, mm	6.0 - 18	7.0 - 18	6.0 - 17	NA	8.5 - 18	5 - 11	7.0 - 19
Abutment Diameter, mm	3.4 - 5.0	3.4 - 5.5	3.0 - 5.4	NP, RP	NA	4.0 - 6.5	3.3 - 5.0
Abutment Angle	0°	0° - 19°	0° - 30°	0° - 30°	NA	0° - 25°	0° - 30°
MATERIAL
Implant	CPTi Gr 4	CPTi Gr 4	CPTi Gr 4	NA	CPTi Gr 4	TI6AL4V	CPTi Gr 4
Surface	Acid-Etched	Acid-Etched	OsseoSpeed™	NA	NanoTite™	HA, TPS, Integra Ti,NanoTite™	Grit blasted andacid etched
Abutment	Ti-6Al-4VCoCr	CPTi Gr 2Ti-6Al-4VCoCrGold alloy	Ti-6Al-4VZirconiaGold alloyPEEK	Ti-6Al-4V	NA	Ti-6Al-4V	Ti-6Al-4VZirconiaGold alloyPOM
Abutment Screw	Ti-6Al-4V	Ti-6Al-4V	Ti-6Al-4V	Ti-6Al-4V	NA	Ti-6Al-4V	Ti-6Al-4V

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510(k) Summary Page 6 of 6

The subject device and predicate devices are substantially equivalent in intended use. Small differences in language in the Indications for Use Statement between the subject device and the primary predicate K051859 do not change the intended use of implant placement and function. Both are implant systems placed in the maxilla or mandible to support single or multi-unit restore chewing function, with possible immediate loading. A comparison of equivalent phrasing for the subject device and primary predicate device is shown in the table below.

Subject Device	Primary Predicate Device – K051859
S.I.N. Dental Implant System is intended for placementin the maxillary or mandibular arch.	The Sistema de Implante Nacional Dental ImplantSystem is intended to be surgically placed in the bone ofthe maxillary and/or mandibular arch
to provide support for single-unit or multi-unitrestorations.	to provide support for crowns, bridges or overdentures
	Implants may be placed immediately after toothextraction or following bone healing.
When a one-stage surgical approach is applied, the S.I.N.Dental Implant System is intended for immediate loadingwhen good primary stability is achieved and withappropriate occlusal loading. Revolution Compact with a6 mm length is intended for delayed loading only.	Restorations supported by two or more Sistema deImplante Nacional implants may be loaded immediatelyafter implant placement if primary implant stability hasbeen achieved.

Subject device implants are substantially equivalent to K051859 implants in body, connection design, material and acid etched surface. The short is substantially equivalent to K092035 in size, surface area and function. Subject device abutments are substantially equivalent to K051859 abutments in material, design and function, with the exception of the design of the ball abutment. Subject device abutments are substantially equivalent to K120414 abutments in material, design and function. Subject device multi-unit abutments are substantially equivalent to K072570 abutments in material, design and function.

CONCLUSION

The subject device and the predicate devices have the same intended use, have similar technological characteristics, and are made of the same or similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including diameter, length and angle of the abutments. The subject and predicate devices are packaged in similar materials and are to be sterilized using similar methods.

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

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.