JJ Implant System Genesis Active implants and Genesis Normo implants are indicated for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations for functional and esthetic rehabilitation. JJ Implant System Genesis Active implants and Genesis Normo implants are indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate.

JJ Implant System Mini implants may be used for denture stabilization using multiple implants in the anterior mandible and the anterior maxilla, and are indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate.

Device Description

The JJ Implant System comprises three lines of endosseous root-form dental implants: two lines with an internal hexagonal prosthetic interface (Genesis Normo), mating abutments, abutments, abutment screws, and other associated components; and a line of one-piece, small diameter dental implants (Mini) for retention of overdentures.

AI/ML Overview

This looks like a 510(k) premarket notification for a dental implant system, which primarily relies on demonstrating substantial equivalence to already legally marketed devices. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically related to non-clinical performance and comparisons to predicate devices, rather than clinical efficacy studies with specific performance metrics like sensitivity/specificity often seen with AI/CADe devices.

Based on the provided document, here's a breakdown of the information:

1. Table of Acceptance Criteria and the Reported Device Performance:

Since this is a dental implant (a passive medical device), the "acceptance criteria" are not framed in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy). Instead, they relate to safety, performance against established standards, and equivalence to predicate devices. The device's "performance" is demonstrated through successful completion of these non-clinical tests and a comparison of its technological characteristics and indications for use with predicate devices.

Acceptance Criterion (Type of Test/Standard)	Reported Device Performance / Compliance
Sterilization Validation (ISO 11137-1, -2, ISO 17665-1, ISO 14937)	Device complies with standards (submitted non-clinical data).
Bacterial Endotoxin Testing (USP 40-NF 35 <85>)	Device complies with standards (submitted non-clinical data).
Biocompatibility (ISO 10993-5, ISO 10993-12)	Confirmatory biocompatibility testing was performed and demonstrates compliance.
Accelerated Aging (ASTM F1980)	Device complies with standards (submitted non-clinical data).
Static Compression Fatigue Testing (ISO 14801)	Demonstrated sufficient strength for intended use for both Genesis Active and Genesis Normo implants (in combinations with a 15° angled abutment).
Surface Evaluation (SEM, EDS, Auger)	Used to evaluate residual materials; implied satisfactory results (no abnormal findings reported).
Equivalence in Indications for Use (IFUS)	Subject device IFUS for Genesis Active and Normo implants is substantially equivalent to predicate K142260 and reference K120414. Minor wording differences do not affect intended use.
Equivalence in IFUS (Mini implants)	Subject device IFUS for Mini implants is substantially equivalent to reference K100932. Minor wording differences do not affect intended use.
Equivalence in Design/Dimensions (Genesis Active)	Substantially equivalent to predicate K142260 and reference K120414 in thread form, prosthesis attachment, restorations, abutment-implant interface, material, and sterilization. Dimensions within corresponding ranges.
Equivalence in Design/Dimensions (Genesis Normo)	Substantially equivalent to reference K120414 in thread form, prosthesis attachment, restorations, abutment-implant interface, material, and sterilization. Dimensions within corresponding ranges.
Equivalence in Design/Dimensions (Abutments)	Substantially equivalent to reference K120414. Includes similar components, dimensions within ranges, and similar attachment/restoration types.
Equivalence in Design/Dimensions (Mini Implants)	Substantially equivalent to reference K100932 in thread form, prosthesis attachment, retention, material, and sterilization. Dimensions within corresponding ranges.
Materials Compliance	Implants, abutments, and abutment screws use Ti-6Al-4V alloy conforming to ASTM F136; materials are similar to predicates.
Sterilization Method (End-user)	Abutments and abutment screws to be moist heat (steam) sterilized by end-user, similar to predicates.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This device clearance is based on non-clinical performance data and substantial equivalence to predicate devices, not on a clinical "test set" with patient data in the context of AI/CADe. Therefore, there's no mention of a clinical test set sample size or its provenance in this document. The "test sets" would refer to the samples used in the mechanical and biocompatibility testing (e.g., number of implants tested for fatigue, number of samples for bacterial endotoxin, etc.), but specific numbers are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study requiring expert readers or ground truth establishment for diagnostic performance.

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

Not applicable, as no clinical "test set" in the diagnostic sense was used or described.

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/CADe device, and no MRMC comparative effectiveness study was done.

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), not an algorithm.

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

Not applicable. For this type of device, "ground truth" is established by adherence to recognized consensus standards for material properties, mechanical strength, biocompatibility, and sterilization, as well as a demonstration of equivalence to legally marketed devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary

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December 6, 2019

JJ Implants % Kevin Thomas Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K190552

Trade/Device Name: JJ Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 1, 2019 Received: November 4, 2019

Dear Kevin Thomas:

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. 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 located 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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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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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.

for

Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K190552

Device Name

JJ 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)

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510(k) Summary K190552 JJ Implant System JJ Implants December 5, 2019

ADMINISTRATIVE INFORMATION

Manufacturer Name	JJ Implants
	IX /214A, Munipara, Kanjirapilly PO
	Chalakudy, Kerala, India 680721
	Telephone	+91 984 600 8283
	Fax	+91 480 274 6353
Official Contact	Dr. Jiju John, Managing Director
Representative/Consultant	Kevin A. Thomas, PhD
	Floyd G. Larson, MS, MBA
	PaxMed International, LLC
	12264 El Camino Real, Suite 400
	San Diego, CA 92130
	Telephone:	+1 858-792-1235
	Fax:	+1 858-792-1236
	Email:	kthomas@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	JJ Implant System
Common Name	Dental implant
Regulation Number	21 CFR 872.3640
Regulation Name	Endosseous dental implant
Regulatory Class	Class II
Product Code	DZE
Classification Panel	Dental Products Panel
Reviewing Office	Office of Health Technology 1(Ophthalmic, Anesthesia, Respiratory, ENT & Dental Devices)
Reviewing Division	Division of Health Technology 1 B (Dental Devices)

PREDICATE DEVICE INFORMATION

Primary Predicate K142260, Nobel Active®, Nobel Biocare USA, LLC

Reference Devices K120414, OsseoSpeed™ Plus, Astra Tech AB K100932, Inclusive Mini Implant, Prismatik Dentalcraft, Incorporated

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INDICATIONS FOR USE STATEMENT

SUBJECT DEVICE DESCRIPTION

Implant Line	Body diameter, mm	Platform diameter, mm	Length, mm
Genesis Active	3.0	3.0	8, 10, 11.5, 13
	3.5	3.5	8, 10, 11.5, 13, 16
	3.75	3.5	8, 10, 11.5, 13, 16
	4.2	3.5	8, 10, 11.5, 13, 16
	5.0	3.5	8, 10, 11.5, 13
Genesis Normo	3.2	3.2	8, 10, 11.5, 13
	3.7	3.7	8, 10, 11.5, 13, 16
	4.2	3.7	8, 10, 11.5, 13, 16
	4.7	4.7	8, 10, 11.5, 13
	5.2	4.7	8, 10, 11.5
Mini	2.2	2.5	10, 11.5, 13, 15

Abutment designs for Genesis Active implants include cover screws, healing abutments, straight abutments, angled abutments (15°), and ball attachment abutments in two platform diameters. Abutment designs for Genesis Normo implants include cover screws, healing abutments, straight abutments, and angled abutments (15°) in three platform diameters. The one-piece Mini implant includes an integral ball attachment for denture retention.

JJ Implant System implants, abutment screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136. All implants are provided sterilized by gamma irradiation; all other components are provided non-sterile to the end user.

PERFORMANCE DATA

Non-clinical data submitted to demonstrate substantial equivalence included: sterilization validation according to ISO 11137-1, ISO 11137-2, ISO 17665-1, and ISO 14937; bacterial endotoxin testing according to USP 40-NF 35 <85>; biocompatibility according to ISO 10993-5 and ISO 10993-12; accelerated aging according to ASTM F1980; and static compression fatigue testing according to ISO 14801. Scanning electron microscopy (SEM), energy dispersive X-ray spectroscopy (EDS), and Auger electron spectroscopy were performed on the RBM grit-blasted threaded surface to

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evaluate residual materials from the blasting or cleaning operations present on the final devices. No clinical data were included in this submission.

EQUIVALENCE TO MARKETED DEVICES

The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. Provided at the end of this summary are tables comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the reference devices.

The Indications for Use Statement (IFUS) for the subject device (the portion of the IFUS for the Genesis Active implants and Genesis Normo implants) is substantially equivalent to that of the primary predicate K142260. Slight differences in the language of the subject device and primary predicate device IFUS do not affect the intended use as an endosseous dental implant abutment for support of a prosthesis to restore chewing function. Minor differences between the IFUS for the subject device and the primary predicate include the specific language in the primary predicate device IFUS concerning splinted and non-splinted applications and delayed loading. These minor differences do not impact substantial equivalence because both IFUS express equivalent intended use to facilitate dental prosthetic restorations, and are expressed equivalently using different specific wording.

Similarly, the differences between the subject device IFUS (the portion of the IFUS for the Genesis Active implants and Genesis Normo implants) and that of the reference devices are related to the specific device names, design features, and use of the devices. None of these minor differences impact substantial equivalence because all IFUS express equivalent intended use to facilitate dental prosthetic restorations, and the indications are expressed equivalently using different specific wording.

The IFUS for the subject device (the portion of the IFUS for the Mini implants) is substantially equivalent to that of the reference device K100932 in terms of stabilization of dentures and immediate loading with primary stability and appropriate loading. The minor differences in the specific wording and do not impact substantial equivalence because the IFUS express equivalent intended use and the indications are expressed equivalently using different specific wording.

The subject Genesis Active implant designs are substantially equivalent to those of the primary predicate K142260 in terms of endosseous thread form designs, prosthesis attachment (cement-retained or screwretained), restorations (single-unit or multi-unit), abutment-implant interface (internal hexagonal connection), material, and sterilization. The ranges of dimensions of body diameter, endosseous length, and platform diameter for the subject Genesis Active implants are within the corresponding ranges of the dimensions of the primary predicate K142260 or of the reference device K120414.

The reference device K120414 is for support of substantial equivalence of the subject Genesis Normo implant designs and for support of substantial equivalence of the subject abutment designs. The subject Genesis Normo implants and the reference device K120414 implants also are substantially equivalent in terms of endosseous thread form designs, prosthesis attachment (cement-retained), restorations (single-unit or multi-unit), abutment-implant interface (internal connection), material, and sterilization. The ranges of dimensions of body diameter, endosseous length, and platform diameter for the subject Genesis Normo implants are within the corresponding ranges of the reference device K120414.

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The subject abutment designs also are substantially equivalent to the abutment designs of the reference device K120414. The subject device and the reference device K120414 both include cover screws, healing abutments, straight abutments, angled abutments, and ball attachments. The ranges of dimensions of platform diameter, gingival height, and angulation for the subject abutments are within the corresponding ranges of the reference device K120414. The subject abutments and the reference device K120414 abutments also are substantially equivalent in terms of prosthesis attachment (cement-retained, screw-retained, ball attachment), restorations (single-unit or multi-unit), abutment-implant interface (internal connection), material, and sterilization (by the end user).

The reference device K100932 is for support of substantial equivalence of the subject Mini implant designs. The ranges of dimensions (body diameter and length) for the subject Mimi implants are within the corresponding ranges of the reference device K100932. The subject device Mini implants are provided in a body diameter of 2.2 mm in lengths of 10, 11.5, 13, and 15 mm; the reference device K100932 implants are provided in body diameters of 2.2. 2.5. and 3 mm. and each body diameter is provided in leneths of 10, 13, and 15 mm. The subject Mini implants and the reference device K100932 implants also are substantially equivalent in terms of endosseous thread form design, prosthesis attachment (ball attachment), retention of dentures, material, and sterilization.

The subject device abutments and abutment screws are to be moist heat (steam) sterilized by the end-user, the same as the primary predicate K142260 and the reference device K120414.

Confirmatory biocompatibility testing of the subject device was performed according to ISO 10993-5 and ISO 10993-12.

Mechanical performance testing was performed according to ISO 14801. For both Genesis Active implants and Genesis Normo implants (each in combinations with a 15° angled abutment) the testing results demonstrated that the subject device implants have sufficient strength for their intended use.

Minor differences in the designs, dimensions, or sizes among the subject device, the primary predicate device, and the reference devices do not affect substantial equivalence. These minor differences do not impact substantial equivalence because these differences are related to the specific designs of the primary predicate or reference devices.

CONCLUSION

The subject device, the primary predicate device, and the reference devices have the same intended use, have similar technological characteristics, and are made of the same materials. The subject device, the primary predicate, and reference devices encompass the same range of physical dimensions, 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.

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Comparison of Indications for Use Statements

Subject Device	Primary Predicate	Reference Device	Reference Device
K190552JJ Implant SystemJJ Implants	K142260Nobel Active®Nobel Biocare USA, LLC	K120414OsseoSpeed™ PlusAstra Tech AB	K100932Inclusive Mini ImplantPrismatik Dentalcraft, Incorporated
JJ Implant System Genesis Active implants and Genesis Normo implants areindicated for placement in the maxillary or mandibular arch to providesupport for single-unit or multi-unit restorations for functional and estheticrehabilitation. JJ Implant System Genesis Active implants and GenesisNormo implants are indicated for immediate loading when good primarystability is achieved and the occlusal loading is appropriate.JJ Implant System Mini implants may be used for denture stabilization usingmultiple implants in the anterior mandible and the anterior maxilla, and areindicated for immediate loading when good primary stability is achieved andthe occlusal loading is appropriate.	NobelActive® implants are endosseous implants intended to be surgicallyplaced in the upper or lower jaw bone for anchoring or supporting toothreplacements to restore patient esthetics and chewing function.NobelActive® implants are indicated for single or multiple unit restorations insplinted or non-splinted applications. This can be achieved by a 2-stage or1-stage surgical technique in combination with immediate, early or delayedloading protocols, recognizing sufficient primary stability and appropriateocclusal loading for the selected technique.NobelActive® 3.0 implants are intended to replace a lateral incisor in themaxilla and/or a central or lateral incisor in the mandible.NobelActive® 3.0 implants are indicated for single unit restorations only.	Implants:The Astra Tech Dental Implants are intended for both one- and two-stagesurgical procedures in the following situations and with the following clinicalprotocols:replacing single and multiple missing teeth in the mandible and maxilla, immediate placement in extraction sites and in situations with a partiallyor completely healed alveolar ridge, especially indicated for use in soft bone applications where implants withother implant surface treatments may be less effective, immediate loading in all indications, except in single tooth situations onimplants shorter than 8 mm or in soft bone (type IV) where implantstability may be difficult to obtain and immediate loading may not beappropriate. The intended use for OsseoSpeed™ Plus 3 .OS is limited to replacement ofmaxillary lateral incisors and mandibular incisors.Abutments:Astra Tech Implant System Plus abutments are intended to be used inconjunction with Astra Tech Implant System Plus in fully edentulous orpartially edentulous maxillary and/or mandibular arches to provide supportfor crowns, bridges or overdentures.Atlantis Abutments:The Atlantis™ Abutment is intended for use with an endosseous implant tosupport a prosthetic device in a partially or completely edentulous patient. Itis intended for use to support single and multiple tooth prostheses, in themandible or maxilla. The prosthesis can be cemented, screw retained orfriction fit to the abutment. The abutment screw is intended to secure theabutment to the endosseous implant.The Atlantis™ Crown Abutment in Zirconia is intended for use with anendosseous implant to function as a substructure that also serves as the finalrestoration, in partially or completely edentulous patients. The prosthesis isscrew retained. The abutment screw is intended to secure the crown abutmentto the endosseous implant.	Inclusive Mini Implants are self-tapping threaded titanium screws indicatedfor long-term applications. Inclusive Mini Implants may also be used forprovisional applications. These devices will allow immediate loading andlong-term stabilization of dentures and provisional stabilization of dentureswhile standard implants heal. To be used for immediate loading only in thepresence of primary stability and appropriate occlusal loading.
		Subject Device	Primary Predicate	Reference Device
Comparison		K190552JJ Implant SystemJJ Implants	K142260Nobel Active®Nobel Biocare USA, LLC	K120414OsseoSpeed™ PlusAstra Tech AB
Intended Use		Functional and esthetic rehabilitation of the edentulous maxillaand mandible	Functional and esthetic rehabilitation of the edentulous maxillaand mandible	Functional and esthetic rehabilitation of the edentulous maxillaand mandible
Reason for Predicate/Reference Device		Not applicable	Predicate for subject Genesis Active implant design	Reference for subject Genesis Normo implant design;Reference for subject abutment designs
Product Codes		DZE, NHA	DZE, NHA	DZE
Implant Designs
	Genesis Active:	3.0, 3.5, 3.75, 4.2, 5.0	3.0, 3.5, 4.3, 5.0, 5.5
Implant Body Diameter (Ø), mm	Genesis Normo:	3.2, 3.7, 4.2, 4.7, 5.2		3.0, 3.6, 4.2, 4.8, 5.4
	Mini:	2.2
	Genesis Active:	6 - 16 (varies by body Ø)	6.5 - 18 (varies by body Ø)
Implant Endosseous Length, mm	Genesis Normo:	8 - 16 (varies by body Ø)		6 - 17
	Mini:	10, 11.5, 13, 15
	Genesis Active:	3.0, 3.5 (varies by body Ø)	3.0, 3.5 (NP), 3.9 (RP), 5.1 (WP)
Platform Ø, mm	Genesis Normo:	3.2, 3.7, 4.7 (varies by body Ø)		3.0, 3.6, 4.2, 4.8, 5.4
	Mini:	Not applicable
Threads	Genesis Active:	Double-lead, square thread form	Square thread form
	Genesis Normo:	Micro-thread at coronal aspect;Single-lead thread form to the apex		Micro-thread at coronal aspect;single lead thread form to the apex
	Mini:	Single-lead thread form to the apex;Self-tapping
Abutment Designs
Cover Screws	Genesis Active:	3.0, 3.5 mm coronal Ø(varies by body Ø)
	Genesis Normo:	3.2, 3.7, 4.7 mm coronal Ø(varies by body Ø)		Cover Screw Plus3.0, 3.6, 4.2, 4.8, 5.4 (to match implant platform Ø)
	Mini:	Not applicable
Healing Abutments	Genesis Active:	4.5, 4.7 mm coronal Ø;2-6 mm gingival height (GH)(varies by body Ø)
	Genesis Normo:	3.7, 4.7, 5.7 mm coronal Ø; 3 mm, 5 mm GH		HealDesign Plus3.0, 3.6, 4.2, 4.8, 5.4 (to match implant platform Ø)
	Mini:	Not applicable
Straight Abutments	Genesis Active:	Engaging, 1-4 mm GH(varies by body Ø)
	Genesis Normo:	Engaging, 1-3 mm GH		TiDesign Plus3.0, 3.6, 4.2, 4.8, 5.4 (to match implant platform Ø)
	Mini:	Straight only; one-piece implant withintegral ball-attachment connection

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Comparison of Technological Characteristics

	Reference Device
	K100932Inclusive Mini ImplantPrismatik Dentalcraft, Incorporated
lous maxilla	Functional and esthetic rehabilitation of the edentulous maxillaand mandible
gn;	Reference device for subject Mini implant design
	DZE



	2.2, 2.5, 3.0


	10, 13, 15


	Not applicable


	Self-tapping










	Straight only; one-piece implant with integral ball-attachmentconnection

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Comparison of Technological Characteristics

Comparison	Subject Device		Primary Predicate	Reference Device	Reference Device
		K190552JJ Implant SystemJJ Implants	K142260Nobel Active®Nobel Biocare USA, LLC	K120414OsseoSpeed™ PlusAstra Tech AB	K100932Inclusive Mini ImplantPrismatik Dentalcraft, Incorporated
Angled Abutments	Genesis Active:	Angled 15°, engaging, 1.25-3 mm GH(varies by body Ø)		Angled TiDesign PlusAngled 15°, 20°	Not applicable (straight only)
	Genesis Normo:	Angled 15°, engaging, 1-4.5 mm GH(varies by body Ø)
	Mini:	Not applicable (straight only)
Other	Genesis Active:	Ball attachments, 0.5-5 mm GH(varies by body Ø)		Ball Abutment Plus3.6, 4.2, 4.8, 5.4 (to match implant platform Ø)each with 1-7 mm GH	Not applicable (straight only)
	Genesis Normo:	Not applicable
	Mini:	Not applicable (straight only)
Prosthesis Attachment	Genesis Active:	Cement-retained, screw-retained		Cement-retained, screw-retained, ball attachment	One-piece implant with integral ball-attachment connection
	Genesis Normo:	Cement-retained, screw-retained	Cement-retained, screw-retained
	Mini:	One-piece implant with integralball-attachment connection
Restoration	Genesis Active:	Single-unit, multi-unit		Single-unit, multi-unit	Multi-unit (denture)
	Genesis Normo:	Single-unit, multi-unit	Single-unit, multi-unit
	Mini:	Multi-unit (denture)
Abutment/ Implant Interface	Genesis Active:	Internal hexagon	Internal hexagon	Internal connection with anti-rotation feature	Not applicable
	Genesis Normo:	Internal hexagon
	Mini:	Not applicable
Materials
Implants	Ti-6Al-4V alloy, with RBM threaded surface		CP titanium, with TiUnite surface	Unalloyed titanium; OsseoSpeed surface	Ti-6Al-4V alloy, with blasted and etched threaded surface
Abutments	Ti-6Al-4V alloy		Ti-6Al-4V alloy	Ti-6Al-4V alloy, Zirconia, Gold, PEEK	Not applicable
Abutment Screws	Ti-6Al-4V alloy		Ti-6Al-4V alloy	Ti-6Al-4V alloy	Not applicable
Sterilization Status/Method
Implants	Sterile by gamma irradiation		Sterile by gamma irradiation	Sterile by gamma irradiation	Sterile (process not stated in 510(k) Summary)
Abutments	Non-sterile; to be moist heat (steam) sterilized		Sterile by gamma irradiation; andNon-sterile; to be moist heat (steam) sterilized	Sterile by gamma irradiation; andNon-sterile; to be moist heat (steam) or dry heat sterilized	Not applicable
Other Components	Non-sterile; to be moist heat (steam) sterilized		Non-sterile; to be moist heat (steam) sterilized	Non-sterile; to be moist heat (steam) sterilized	Not applicable

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.