Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients.

They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

Device Description

The subject devices are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding abutments and healing components as well as instruments and prosthetic parts. Straumann® dental implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a saline solution (NaCl). Straumann® dental implants can be used following the extraction or loss of natural teeth to restore chewing function. The prosthetic restorations supported are single crowns, bridges and partial or full dentures, which are connected to the implants using the corresponding abutments.

The purpose of this premarket notification is to extend the BLC and TLC Implants portfolio by including new sizes of implants, more specifically:

BLC implants:

L 16 mm for diameter Ø 6.5 mm, presented with WB (Wide Base) prosthetic platform.
TLC implants:
L 14 mm and L 16 mm for diameter Ø 5.5 mm, with both implant neck options Standard (2.8 mm height) and Standard Plus (1.8 mm height)
L 8 mm and L 10 mm for diameter Ø 6.5 mm and implant neck Standard (2.8 mm height)
L 12 mm to L 16 mm for diameter Ø 6.5 mm, with both implant neck options Standard (2.8 mm height)

and presented with WT (Wide TorcFit) prosthetic platform.

The submission also introduces a new sterilization method using X-ray irradiation which was validated on worst-case test articles representative of the BLC and TLC implant systems.

AI/ML Overview

This is a 510(k) summary for a medical device that is cleared based on substantial equivalence to predicate devices, not on meeting specific performance acceptance criteria in the same way an AI/ML device might. Therefore, many of the requested categories are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

Device Type: This document is for an Endosseous Dental Implant, not a software or AI/ML device. The acceptance criteria and performance study described are focused on hardware aspects (sterilization, biocompatibility, mechanical performance) rather than algorithmic performance.

Applicable Information from the document:

Since this is a dental implant and not an AI/ML device, concepts like "test set," "training set," "experts to establish ground truth," and "MRMC study" are not relevant in the context of the device's technical clearance. The document focuses on showing the new implants are substantially equivalent to previously cleared implants.

1. A table of acceptance criteria and the reported device performance

Feature/Test	Acceptance Criteria (Implied by Equivalence/Standards)	Reported Device Performance (Summary)
Sterility	Sterility Assurance Level (SAL) of 10⁻⁶	Validated to SAL of 10⁻⁶ for both gamma and X-ray irradiation (ISO 11137-1:2006, ISO 11137-2:2013). No higher challenge to sterilization than predicate.
Shelf-life	5 years sterile	Confirmed 5 years sterile shelf life.
Non-pyrogenicity	Meets pyrogen limit specifications (20 EU/device)	LAL Endotoxin Analysis demonstrated meeting 20 EU/device for blood-contacting/implanted devices.
Biocompatibility	Biologically safe for intended use (ISO 10993-1, FDA Guidance)	Assessed devices showed no adverse reactions with X-ray sterilization at T0, T3, T5; considered biologically safe. Materials, surface, manufacturing, packaging, body contact duration equivalent to predicate.
Electromagnetic Compatibility (EMC)	MR Conditional status	Considered MR Conditional per K180540, tested per FDA Guidance. No new EMC issues raised.
Mechanical Performance (Insertion Torque)	Adequate insertion torque in different bone classes	Insertion tests performed, proven adequate insertion torque.
Surface Treatment	Identical to predicate/reference devices (SLActive®)	Routinely tested by roughness measurement or scanning electron microscopy; identical to predicate.

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

Sterilization Validation: The document mentions "worst-case test articles representative of the BLC and TLC implant systems" for X-ray sterilization validation. It does not provide a specific sample size. The methods (VDmax25) are standard for radiation sterilization validation.
Biocompatibility Testing: The document refers to "assessed devices" and "conducted tests" (e.g., at T0, T3, T5 for X-ray sterilization impact). Specific sample sizes are not provided, but the testing followed ISO 10993-1.
Mechanical Testing (Insertion Torque): "Insertion tests were performed for the subject implants." No specific sample size is given.
Data Provenance: The studies appear to be internal validation studies conducted by the manufacturer, not patient data from specific countries. They are prospective in the sense of being planned validation tests for the device changes.

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

This concept is not applicable as the studies described are bench and lab validations against industry standards (ISO, FDA guidance), not expert-interpreted clinical data. The "ground truth" is defined by the technical specifications and performance against those standards.

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

Not applicable for these types of technical validation studies. Adjudication methods are typically used in clinical trials or studies involving human interpretation of medical images or data.

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 is not an AI/ML device, nor does it involve human readers interpreting data assisted by the device.

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

Not applicable. This is a physical medical device (dental implant).

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

The "ground truth" in this context is defined by established international standards (e.g., ISO 11137 for sterilization, ISO 10993-1 for biocompatibility, FDA guidance for MR Conditional status) and the engineering specifications/performance achieved by the device. It's essentially performance against predefined engineering and safety standards.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

Conclusion based on the document:

The device is an extension of existing dental implants, and its clearance relies on demonstrating substantial equivalence to predicate devices. The "acceptance criteria" are implied by the need to conform to generally recognized standards and to demonstrate that the new sizes and sterilization method do not introduce new safety or effectiveness concerns compared to the predicates. The studies performed are primarily bench testing and validation studies to confirm the physical and biological characteristics of the implants meet these standards.

Summary

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March 20, 2024

Institut Straumann AG % Jennifer Jackson Sr. Director, Regulatory Affairs and Ouality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K234049

Trade/Device Name: Straumann® BLC and TLC Implants - Line extension Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: December 21, 2023 Received: December 21, 2023

Dear Jennifer Jackson:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K234049

Device Name

Straumann® BLC and TLC Implants - Line extension

Indications for Use (Describe)

Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Straumann® BLC and TLC Implants - Line extension

510(k) Summary

1 Submitter's Contact Information

Submitter:	Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052On the behalf of:Institut Straumann AGPeter Merian Weg 124052 Basel, Switzerland
Contact Person:	Jennifer M. Jackson, MS, RACSr. Director, Regulatory Affairs and QualityPhone Number: +1-978-747-2509Fax Number: +1-978-747-0023
Prepared By &Alternate Contact:	Laure Kuhner BorsenbergerRegulatory Affairs and Compliance ManagerInstitut Straumann AGPhone number: +41 79 828 9414
Date of Submission:	March 19, 2024

Name of the Device 2

Trade Names:	Straumann® BLC and TLC Implants - Line extension
Common Name:	Endosseous Dental Implant
Classification Name:	Endosseous Dental Implant
Regulation Number:	§872.3640
Device Classification:	II
Product Code(s):	DZE
Classification Panel:	Dental

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Straumann® BLC and TLC Implants - Line extension

510(k) Summary

Predicate Device(s) ന

Primary Predicate:

K230108 Straumann® BLC and TLC Implants .
Reference Devices:
K212533 BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants .

Device Description ব

The purpose of this premarket notification is to extend the BLC and TLC Implants portfolio by including new sizes of implants, more specifically:

BLC implants:

L 16 mm for diameter Ø 6.5 mm, presented with WB (Wide Base) prosthetic platform.

TLC implants:

L 14 mm and L 16 mm for diameter Ø 5.5 mm, with both implant neck options Standard (2.8 mm height) and Standard Plus (1.8 mm height)
L 8 mm and L 10 mm for diameter Ø 6.5 mm and implant neck Standard (2.8 mm height)
L 12 mm to L 16 mm for diameter Ø 6.5 mm, with both implant neck options Standard (2.8 mm height) and Standard Plus (1.8 mm height)

and presented with WT (Wide TorcFit) prosthetic platform.

The submission also introduces a new sterilization method using X-ray irradiation which was validated on worst-case test articles representative of the BLC and TLC implant systems.

A summary of the diameter/length implant body combinations is given in Table 1.

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Straumann® BLC and TLC Implants - Line extension

	BLC implant	TLC implant
Implant Diameter	$\varnothing$ 6.5mm	$\varnothing$ 5.5mm	$\varnothing$ 6.5mm
Implant Length	-	-	8 mm - S
	-	-	10 mm - S
	-	-	12 mm - S & SP
	-	14 mm - S & SP	14 mm - S & SP
	16 mm	16 mm - S & SP	16 mm - S & SP
Prosthetic platforms	WB	WT	WT

510(k) Summary

Table 1 - Overview of diameter/length implant body combinations

Intended Use 5

Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices.

Indications for Use 6

Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients.

They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multipletooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

Technological Characteristics 7

The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following table:

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Straumann® BLC and TLC Implants - Line extension

510(k) Summary

FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE	REFERENCE DEVICE	EQUIVALENCE
K Number/name	K234049BLC & TLC Implant Line extension	K230108Straumann® BLC and TLC Implants	K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5mm (L14 and L16) Implants	DISCUSSION
Indicationsfor Use	Straumann® dental implants areindicated for the functional and estheticoral rehabilitation of the upper or lowerjaw of edentulous or partially edentulouspatients. They can be used forimmediate, early or late implantationfollowing the extraction or loss of naturalteeth. The implants can be placed withimmediate function for single-toothand/or multiple-tooth restorations whengood primary stability is achieved andwith appropriate occlusal loading torestore chewing function.	Straumann® dental implants areindicated for the functional and estheticoral rehabilitation of the upper or lowerjaw of edentulous or partially edentulouspatients. They can be used forimmediate, early or late implantationfollowing the extraction or loss of naturalteeth. The implants can be placed withimmediate function for single-toothand/or multiple tooth restorations whengood primary stability is achieved andwith appropriate occlusal loading torestore chewing function.	Straumann® dental implants areindicated for the functional andesthetic oral rehabilitation of theupper or lower jaw of edentulous orpartially edentulous patients. Theycan be used for immediate, early orlate implantation following theextraction or loss of natural teeth.The implants can be placed withimmediate function for single-toothand/or multiple-tooth restorationswhen good primary stability isachieved and with appropriateocclusal loading to restore chewingfunction.	Identical to primarypredicate andreference device
Material	Titanium-13 Zirconium alloy (Roxolid®)	Titanium-13 Zirconium alloy (Roxolid®)	Titanium-13 Zirconium alloy(Roxolid®)	Identical to primarypredicate andreference device
SurfaceTreatment	Hydrophilic SLActive®	Hydrophilic SLActive® and SLA®	Hydrophilic SLActive® and SLA®	Identical to primarypredicate andreference device
Implant toAbutmentConnection	TorcFit(with conical fitting)	TorcFit(with conical fitting)	TorcFit(with conical fitting)	Identical to primarypredicate andreference device
ImplantDiameter andLength	BLC implants:Ø 6.5: 16 mmTLC implants:Ø 5.5: 14 and 16 mm (S and SP)Ø 6.5: 8 and 10 mm (S only)Ø 6.5: 12, 14, 16 mm (S and SP)	BLC implants:Ø 3.3: 8, 10, 12, 14, 16, 18 mmØ 3.75 and 4.5: 6, 8, 10, 12, 14, 16, 18 mmØ 5.5: 6, 8, 10, 12, 14, 16 mmØ 6.5: 6, 8, 10, 12, 14 mmTLC implants:Ø 3.3: 8, 10, 12, 14, 16, 18 mm (S and SP)Ø3.75 and 4.5: 6, 8, 10, 12, 14, 16, 18 mm (S and SP)Ø 5.5: 6, 8, 10, 12 mm (S and SP)Ø 6.5: 6 mm (S and SP)Ø 6.5: 8 and 10 mm (SP only)	Ø 5.0: 18 mmØ 5.5 and 6.5: 14 and 16 mm	Extension of primarypredicate, implantabledimensions identical toreference device
FEATURE	PROPOSED DEVICE	PRIMARY PREDICATE	REFERENCE DEVICE	EQUIVALENCE DISCUSSION
K Number/ name	K234049BLC & TLC Implant Line extension	K230108Straumann® BLC and TLC Implants	K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
Implant Design	Apically tapered Bone Level implant andApically tapered Tissue Level implant	Apically tapered Bone Level implant andApically tapered Tissue Level implant	Fully tapered Bone Level implant	Identical to primary predicate
Thread Pitch	1.15 mm	0.8, 0.9, 1 and 1.15 mm	2.5 to 3.1 mm	Identical to primary predicate
Sterilization Method	Irradiation(gamma and x-ray)	Irradiation(gamma)	Irradiation(gamma)	Equivalent to primary predicate and reference device.The two sterilization methods are comparable in terms of their sterilization principle (photons), with some technical advantages for X-ray such better dose uniformity, less oxidative stress for certain materials and processing time.Both methods are validated by Straumann.

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Straumann® BLC and TLC Implants - Line extension

510(k) Summary

Table 2 – Comparison matrix: subject device versus primary predicate and reference device

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Traditional 510(k) Submission - K234049 Straumann® BLC and TLC Implants - Line extension

Performance Testing 8

Sterilization Validation and Shelf-life

The subject devices are provided sterile via gamma irradiation at a dose of 25 kGy and will be sterilized after final packaging. The sterilization process for the subject devices as recommended in the labeling was validated to a sterility assurance level (SAL) of 10° in accordance with ISO 11137-1:2006, "Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, 2006-04-05". The validation method used was the over kill bioburden (or VDmax25) method in accordance with ISO 11137- 2:2013, "Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose". There are no changes to the gamma irradiation sterilization procedures or processes from those of the Straumann primary predicate devices (K230108), the subject devices do not represent a higher challenge to the sterilization process in comparison to the validated worst-case product and validated gamma irradiation sterilization process.

In addition, a validation of the X-ray irradiation as a new sterilization method was conducted. The validation method used was the VDma25. A sterility assurance level (SAL) of 10 ° was validated in compliance with ISO 11137-1:2006, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices, 2006-04-05 and ISO 11137-2:2013, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose.

The packaging of the subject device is equivalent to the packaging of the primary predicate and reference device. The shelf life for devices provided sterile is 5 years.

The devices will not be marketed as non-pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016." The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device.

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Traditional 510(k) Submission - K234049 Straumann® BLC and TLC Implants - Line extension

Biocompatibility Testing

Biological assessment has been performed according to ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and to the FDA Guidance document "Use of International Standard ISO 10993- 1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016" for each of the subject devices.

The subject devices are equivalent in material, surface, manufacturing process, packaging materials, sterilization by gamma irradiation, body contact duration compared to the reference device K230108. Sterilization by X-ray irradiation was validated and may be used as an alternative sterilization method instead of gamma irradiation. The impact on the biological safety was evaluated and the needed biocompatibility testing was determined according to the ISO 10993-1:2018 standard. The results of the conducted tests have demonstrated that the assessed devices do not show any reactions with X-ray sterilization that could have a biological effect on the patient at T0 (no aging), T3 (3 years accelerated aging) and T5 (5 years accelerated aging for long-term effect). Thus, the subject devices are considered biologically safe for their intended use according to ISO 10993-1 and FDA's guidance document of ISO 10993-1.

Electromagnetic Compatibility

There are no significant changes to the materials and dimensions from the currently marketed predicate devices. Therefore, no new issues of electromagnetic compatibility are raised for the subject devices and they can be considered MR Conditional.

The subject implants have obtained the status of MR Conditional per K180540. The MR Conditional tests were conducted according to FDA's Guidance "Testing and Labeling Medical Devices for Safety in Magnetic Resonance (MR) Environment".

Performance Testing - Bench

Insertion tests were performed for the subject implants and it could be proven that there is an adequate insertion torque in different bone classes when the implant is inserted according to the surgical procedure.

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Traditional 510(k) Submission - K234049 Straumann® BLC and TLC Implants - Line extension

The subject device surface treatments are identical to the surface treatments of the primary predicate and reference devices. The SLActive® surface treatment is a sand-blasted, large grit, acid etched, chemically active and hydrophilic surface is routinely tested by roughness measurement or scanning electron microscopy.

Conclusion

The documentation submitted in this premarket notification demonstrates the subject devices are substantially equivalent to the primary predicate and reference 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.