NobelActive® implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function.

NobelActive® implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

NobelActive® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible.

NobelActive® 3.0 implants are indicated for single unit restorations only.

Device Description

Nobel Biocare's NobelActive® implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients. They are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The NobelActive® implants are available in diameters 3.0, 3.5, 4.3, 5.0, and 5.5 mm. They are available in lengths between 6.5 mm to 18 mm depending upon implant diameter.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting studies for the NobelActive® dental implant, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative sense with clear thresholds for success (e.g., "must achieve X% success rate"). Instead, it describes performance benchmarks relative to existing devices and clinical expectations for dental implants.

Acceptance Criterion (Implicit)	Reported Device Performance
Mechanical Performance:
Validation of recommended drilling protocols	Implant (4.3x13 mm) fully seated in Type 3 bone surrogate at 55 N cm using 2.8/3.2 last drill. Implant fully seated in Type 4 bone surrogate at 45 N cm using 2.4/2.8 last drill.
Primary stability and micro-motion performance	Exhibited significantly less micro-motion than comparator devices in both 30 pcf (Type II to III) and 20 pcf (Type III to IV) bone surrogates (p ≤ 0.05). Showed higher mechanical resistance to cyclic loads in a clinically relevant loading scenario.
Clinical Performance:
Achievable insertion torque for immediate loading	Mean insertion torque: 51.1 (SD 19.5) N cm in all bone qualities (healed sites). Mean insertion torque: 46.15 (SD 17.5) N cm in predominantly cancellous bone (Type 3 and 4) (healed sites). Mean insertion torque: 47.21 (SD 11.4) N cm in all bone qualities (extraction sites). Mean insertion torque: 48.00 (SD 11.45) N cm in predominantly cancellous bone (Type 3 and 4) (extraction sites). Clinicians could reach high insertion torques, often in the 30-40 N cm range (for immediate loading in soft bone).
Success/Survival Rate (especially in challenging bone qualities)	In healed and extraction sites (predominantly cancellous bone, Type III and IV): 97% successful after 3 years (out of 164 implants, 5 failed). In healed sites: 96.8% successful. In extraction sites: 97.2% successful. In a separate prospective study (Irinakis and Wiebe, 2009): 2.1% failure rate (140 implants, 24 in soft bone) during observation period. In another study (Demanet et al, 2011): 99.1% total survival rate (466 implants), 98.3% in posterior maxilla (soft bone).
Performance in soft bone (Type IV/posterior maxilla)	Irinakis and Wiebe (2009): Mean insertion torque of 47.9 N cm in soft bone (similar to medium bone). Demanet et al (2011): 98.3% survival rate in posterior maxilla.

2. Sample Size Used for the Test Set and Data Provenance

Bench Studies:
- Drilling protocols: 1 implant (4.3x13 mm) tested in each of two bone surrogate types.
- Primary stability and micro-motion: Not explicitly stated, but "different implant geometries and simulated bone densities" were used with "comparator devices." The number of implants per geometry/density is not provided.
- Provenance: Not explicitly stated, but these are non-clinical (laboratory) studies.
Clinical Studies:
- Study 1 (Healed Sites): 199 NobelActive® implants.
- Study 2 (Extraction Sites): 137 NobelActive® implants.
- Study 3 (Implant Handling): 88 implants.
- Study 4 (Irinakis and Wiebe, 2009): 140 implants.
- Study 5 (Demanet et al, 2011): 466 implants.
- Data Provenance: The document does not explicitly state the country of origin. Clinical studies are inherently prospective to some extent, but the reporting here is retrospective (summarizing past studies). The "Irinakis and Wiebe (2009) conducted a prospective study" explicitly states it was prospective. The other clinical data descriptions imply retrospective analysis of existing clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Bench Studies: Ground truth is based on physical measurements and engineering principles. Experts (engineers, researchers) are involved in conducting and interpreting these tests, but their specific number or dental qualifications are not specified as they relate to the "ground truth" of implant performance in a lab setting.
Clinical Studies:
- Bone quality classification (Lekholm and Zarb) was done "by the treating surgeon" according to standard methods, including imaging, pre-surgical investigation, and tactile sensation.
- "Four (4) clinicians" placed implants in the implant handling study.
- The studies mentioned clinical investigators/treating surgeons for implant placement and follow-up. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not provided. However, a "treating surgeon" or "clinician" implies medical/dental professionals experienced in implantology.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (like 2+1 or 3+1 consensus) for the clinical outcomes or data interpretation. Clinical results are typically derived from direct observation and measurement on patients, with success/failure criteria defined within each study's protocol.

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

This document is for a dental implant (a physical device), not an AI/software device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not conducted.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

As noted above, this submission is for a physical medical device (dental implant). It does not involve an algorithm or AI, so the concept of standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

Bench Studies: Physical measurements (torque, micro-motion, seating depth) in simulated environments (bone surrogates).
Clinical Studies:
- Clinical outcomes: Implant success/failure rates, survival rates, insertion torque values, bone quality classification by the treating surgeon. This is essentially direct clinical observation and measurement of "real-world" performance in patients.

8. The Sample Size for the Training Set

This submission pertains to a physical dental implant, not a machine learning model. Therefore, the concept of a "training set" in the context of AI/algorithms is not applicable. The clinical data described contributes to the overall evidence base for the device's performance, rather than serving as a training set for an algorithm.

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

Since this is not an AI/ML device, there is no "training set" and thus no ground truth established for one. The clinical studies mentioned contribute to demonstrating the device's safety and effectiveness for its intended use.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of a human face in profile, with three overlapping profiles creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 11, 2015

Nobel Biocare AB c/o Ms. Ji Eun Hwang Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887

Re: K142260

Trade/Device Name: NobelActive® Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 7, 2015 Received: April 8, 2015

Dear Ms. Hwang:

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 (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 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/Resourcesfor You/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.

Sincerely yours,

lina ang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142260

Device Name NobelActive(R)

Indications for Use (Describe)

Nobel Active® implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

NobelActive® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible.

NobelActive® 3.0 implants are indicated for single unit restorations only.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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A.4.

510(k) Summary

K142260

I. SUBMITTER

Nobel Biocare AB Vastra Hamngatan 1 Goteborg, Sweden SE-411 17

Contact Name: Ji Eun Hwang, Sr. Regulatory Affairs Manager Phone: 714-282-4800 x5030 Fax: 714-998-9348

Date Prepared: March 20, 2015

II. DEVICE

Proprietary Name: NobelActive® Common or Usual Name: Endosseous Dental Implant Classification Name: Endosseous Dental Implant (21 CFR 872.3640) Regulatory Class: II Product Code: DZE, NHA

III. PREDICATE DEVICE

Nobel Biocare – NobelActive® Internal Connection Implant (K071370 Primary Predicate)

Nobel Biocare - NobelActive® 8.5 mm & 18.0 mm (K083205 Reference Predicate)

Nobel Biocare – NobelActive® 3.0 (K102436 Reference Predicate)

Nobel Biocare – NobelActive® Wide Platform (WP) (K133731 Reference Predicate)

IV. DEVICE DESCRIPTION

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edentulous patients. They are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The NobelActive® implants are available in diameters 3.0, 3.5, 4.3, 5.0, and 5.5 mm. They are available in lengths between 6.5 mm to 18 mm depending upon implant diameter.

This premarket notification is being submitted to support labeling changes. No additional implants are being introduced.

V. INDICATIONS FOR USE

NobelActive® implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols. recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

NobelActive® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible.

NobelActive® 3.0 implants are indicated for single unit restorations only.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

	CHARACTERISTIC	CANDIDATE	PRIMARYPREDICATE	REFERENCEPREDICATE	REFERENCEPREDICATE	REFERENCEPREDICATE
		NobelActive®	NobelActive® InternalConnection Implant(K071370)	NobelActive® 8.5 mm &18.0 mm (K083205)	NobelActive® 3.0(K102436)	NobelActive® WidePlatform (WP)(K133731)
Features	Thread Design	Double lead threadReverse cutting flutes	Double lead threadReverse cutting flutes	Double lead threadReverse cutting flutes	Double lead threadReverse cutting flutes	Double lead threadReverse cutting flutes
	Implant BodyDesign	Expanding TaperDrilling blades on apex	Expanding TaperDrilling blades on apex	Expanding TaperDrilling blades on apex	Expanding TaperDrilling blades on apex	Expanding TaperDrilling blades on apex
	Implant Length	7.0, 8.5, 10.0, 11.5, 13.0,15.0, 18.0 mm	10.0, 11.5, 13.0 mm	8.5, 18.0 mm	10.0, 11.5, 13.0, 15.0 mm	7.0, 8.5, 10.0, 11.5, 13.0 mm
	Implant Width	3.0, 3.5, 4.3, 5.0, 5.5mm	3.5, 4.3, 5.0 mm	3.5, 4.3, 5.0 mm	3.0 mm	5.5 mm
	ConnectionType	Internal Hex	Internal Hex	Internal Hex	Internal Hex	Internal Hex
	Device Material	CP Titanium	CP Titanium	CP Titanium	CP Titanium	CP Titanium
	Surface	TiUnite	TiUnite	TiUnite	TiUnite	TiUnite
	Intended Use/Principles of Operation		Nobel Biocare'sNobelActive®implants arethreaded, root-formdental implantsintended for use inthe upper and/orlower jaw to supportprosthetic devices,such as artificialteeth, in order torestore patientesthetics andchewing function topartially or fullyedentulous patients.	Nobel Biocare'sNobelActive® implantsare threaded, root-form dental implantsintended for use in theupper and/or lowerjaw to supportprosthetic devices,such as artificial teeth,in order to restorepatient esthetics andchewing function topartially or fullyedentulous patients.	Nobel Biocare'sNobelActive® implantsare threaded, root-form dental implantsintended for use in theupper and/or lowerjaw to supportprosthetic devices,such as artificial teeth,in order to restorepatient esthetics andchewing function topartially or fullyedentulous patients.	Nobel Biocare'sNobelActive® implantsare threaded, root-form dental implantsintended for use in theupper and/or lowerjaw to supportprosthetic devices,such as artificial teeth,in order to restorepatient esthetics andchewing function topartially or fullyedentulous patients.

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Comparison of Indications for Use

Candidate: NobelActive®

NobelActive® implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

NobelActive® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible.

NobelActive® 3.0 implants are indicated for single unit restorations only.

Primary Predicate: NobelActive® Internal Connection Implant (K071370) Nobel

Biocare's NobelActive® implants are endosseous implants intended to be surgically placed in the bone of the upper and/or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive® implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

Predicate: NobelActive 8.5 mm & 18.0 mm (K083205)

Nobel Biocare's NobelActive® implants are endosseous implants intended to be surgically placed in the bone of the upper and/or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive® implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive® implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

Predicate: NobelActive 3.0 (K102436)

The NobelActive® 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisions to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelActive® 3.0 implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.

Predicate: NobelActive Wide Platform (WP) (K133731)

Nobel Biocare's NobelActive® implants are endosseous implants intended to be surgically placed in the bone of the upper and/or lower jaw arches to provide support for

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prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive® implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive® implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

VII. PERFORMANCE DATA

Non-Clinical Data

Two bench studies were conducted to demonstrate performance of the subject device.

The first study validated the recommended drilling protocols by placing implants in various bone surrogates. Results support that the implant (4.3x13 mm) was fully seated in a Type 3 bone surrogate at 55 N cm when using a 2.8/3.2 as the last drill. The implant was fully seated in a Type 4 bone surrogate at 45 N cm when using a 2.4/2.8 as the last drill.

The second study evaluated primary stability and micro-motion with different implant geometries and simulated bone densities (i.e. 30 pcf - Type II to III, and 20 pcf - Type III to IV per Lekholm and Zarb). After placement, the implants were subjected to sinusoidal loading intended to simulate immediate mechanical loading for approximately 3 months. NobelActive® implants exhibited significantly less micro-motion than the comparator devices in both bone surrogates (p ≤ 0.05). The study also demonstrated that the NobelActive® implants showed higher mechanical resistance to cyclic loads in a clinically relevant loading scenario.

Clinical Data

Several studies support the substantial equivalence of the subject device.

In two separate clinical studies, NobelActive® implants were placed in healed sites and in extraction sites. The classification of bone quality was done per Lekholm and Zarb by the treating surgeon according to standard methods including imaging, presurgical investigation of the site/patient, and tactile sensation. The study protocols used a 1-stage surgical procedure (i.e. no submerged healing) in combination with an immediate loading protocol. Insertion procedures were performed according to the individual needs of the site using the recommended drill protocols in the Instructions for Use.

A total of 199 NobelActive® implants were placed in healed sites (7 - Quality Type 4, 86 - Ouality Type 3, 88 - Quality Type 2, and 18 - Ouality Type 1). The mean insertion torque achieved with NobelActive® implants was 51.1 (SD 19.5) N cm in all bone qualities and 46.15 (SD 17.5) N cm in predominantly cancellous bone (Quality 3 and 4 according to Lekholm and Zarb). The study had a control group (NobelReplace), which achieved a lower mean, i.e. 41.3 (SD 11.6) N cm in all bone qualities. In cancellous

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bone, the control group (NobelReplace) also achieved a lower insertion torque of 39.29 (SD 8.55) N cm compared to the values achieved with NobelActive®.

137 NobelActive® implants were placed in extraction sites (2 - Quality Type 4, 70 -Ouality Type 3, 63 - Ouality Type 2, and 2 - Ouality Type 1). The mean insertion torque achieved with NobelActive® implants was 47.21 (SD 11.4) N cm in all bone qualities and 48.00 (SD 11.45) N cm in predominantly cancellous bone (Quality 3 and 4 according to Lekholm and Zarb).

Between these two studies, a total of 164 NobelActive® were placed in predominantly cancellous bone (Type III and IV) in both extraction (72 implants) and healed (93 implants) sites, of which 5 implants had failed; meaning that 97% of the implants were successful after 3 years. In healed sites, 96.8% of the implants were successful and in extraction sites 97.2% were successful. Those numbers are well in the range of usually reported values for other implants in all types of bone.

In a separate implant handling study, four (4) clinicians placed 88 implants (26 in soft bone (Type 4), 47 in medium bone (Type 3/2), and 13 in dense bone (Type 1; 2 missing values). Data from this study showed that clinicians underprepared sites in soft bone and could reach high insertion torques, most often in the range required for immediate loading (lowest reported range 30 - 40 N cm).

Irinakis and Wiebe (2009) conducted a prospective study on NobelActive® implants. Within a 13 month period, a total of 140 implants were placed in the maxilla and mandible in both extraction and grafted sites. Of these sites, 24 were classified by the investigator as being soft quality bone. The mean insertion torque achieved was 47.9 N cm, which is the exact same mean as seen in medium bone, and is slightly lower than in dense bone. The implants were successful as there was only a 2.1% failure rate (of all implants placed) during the observation period.

Demanet et al (2011) reported 3 year results of 466 implants placed in all jaw regions, of which 58 implants were in the posterior maxilla, a usually very soft bone quality. The total survival rate was 99.1% and for the posterior region it was 98.3%, leading to the assumption that the implant performed well in all jaw bone regions.

VII. CONCLUSION

The differences in intended use between the subject and predicate devices (primary and reference devices) are the identification of the available surgical protocols and the inclusion of all previously cleared lengths and widths of the Nobel Active family of products. These changes do not alter the intended use of the device, which is to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. The changes instead encompass and harmonize the intended use for all NobelActive family products.

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Furthermore, the subject devices have the same design characteristics, implant to-abutment connections (3.0, NP, RP, WP), materials (CP Ti), surface treatment (TiUnite), internal hex connection, packaging and sterilization process as the identified primary and reference predicate devices. Additionally, the subject device encompasses all previously cleared dimensions of the primary and reference predicate devices.

Based on the information provided above and within this submission, the subject devices are substantially equivalent to the predicate devices.

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.