JJ Implant System

K190552 · Jj Implants · DZE · Dec 6, 2019 · Dental

Device Facts

• Record ID: K190552
• Device Name: JJ Implant System
• Applicant: Jj Implants
• Product Code: DZE · Dental
• Decision Date: Dec 6, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

JJ Implant System consists of three endosseous root-form dental implant lines: Genesis Active, Genesis Normo, and Mini. Genesis Active and Normo are two-piece systems with internal hexagonal prosthetic interfaces; Mini is a one-piece implant with an integral ball attachment. Implants are surgically placed in the maxilla or mandible by dental clinicians to support prosthetic restorations. Genesis Active and Normo support single or multi-unit restorations; Mini supports denture stabilization. All lines allow immediate loading if primary stability is sufficient. The system includes various abutments (cover screws, healing, straight, angled, ball attachments) to facilitate prosthetic attachment. Implants are provided sterile via gamma irradiation; other components are non-sterile and require steam sterilization by the user. The device provides a foundation for functional and esthetic dental rehabilitation, benefiting patients by restoring chewing function and denture stability.

Clinical Evidence

No clinical data were included in this submission. Substantial equivalence is supported by non-clinical bench testing, including sterilization validation, bacterial endotoxin testing, biocompatibility (ISO 10993-5/12), accelerated aging (ASTM F1980), and static compression fatigue testing (ISO 14801).

Technological Characteristics

Implants and abutment screws are manufactured from Ti-6Al-4V alloy (ASTM F136). Implants feature an RBM grit-blasted threaded surface. Genesis Active/Normo use an internal hexagonal connection. Mini implants are one-piece with an integral ball attachment. Sterilization: Implants (gamma irradiation), other components (moist heat/steam).

Indications for Use

Indicated for patients requiring dental prosthetic restoration in the maxillary or mandibular arch. Genesis Active and Normo implants support single or multi-unit restorations. Mini implants are indicated for denture stabilization in the anterior mandible and maxilla. All implants are indicated for immediate loading provided primary stability and appropriate occlusal loading are achieved.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Nobel Active® (K142260)

Reference Devices

• OsseoSpeed™ Plus (K120414)
• Inclusive Mini Implant (K100932)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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 | [phone] |
| | Fax | [phone] |
| 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: | [phone] |
| | Fax: | [phone] |
| | Email: | [e-mail]<br>[e-mail] |

#### 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<br>(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

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.

## SUBJECT 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. The implant body diameters, platform diameters, and lengths are summarized in the following table.

| 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 | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| K190552<br>JJ Implant System<br>JJ Implants | K142260<br>Nobel Active®<br>Nobel Biocare USA, LLC | K120414<br>OsseoSpeed™ Plus<br>Astra Tech AB | K100932<br>Inclusive Mini Implant<br>Prismatik Dentalcraft, Incorporated | |
| JJ Implant System Genesis Active implants and Genesis Normo implants are<br>indicated for placement in the maxillary or mandibular arch to provide<br>support for single-unit or multi-unit restorations for functional and esthetic<br>rehabilitation. JJ Implant System Genesis Active implants and Genesis<br>Normo implants are indicated for immediate loading when good primary<br>stability is achieved and the occlusal loading is appropriate.<br><br>JJ Implant System Mini implants may be used for denture stabilization using<br>multiple implants in the anterior mandible and the anterior maxilla, and are<br>indicated for immediate loading when good primary stability is achieved and<br>the occlusal loading is appropriate. | NobelActive® implants are endosseous implants intended to be surgically<br>placed in the upper or lower jaw bone for anchoring or supporting tooth<br>replacements to restore patient esthetics and chewing function.<br><br>NobelActive® implants are indicated for single or multiple unit restorations in<br>splinted or non-splinted applications. This can be achieved by a 2-stage or<br>1-stage surgical technique in combination with immediate, early or delayed<br>loading protocols, recognizing sufficient primary stability and appropriate<br>occlusal loading for the selected technique.<br><br>NobelActive® 3.0 implants are intended to replace a lateral incisor in the<br>maxilla and/or a central or lateral incisor in the mandible.<br><br>NobelActive® 3.0 implants are indicated for single unit restorations only. | Implants:<br>The Astra Tech Dental Implants are intended for both one- and two-stage<br>surgical procedures in the following situations and with the following clinical<br>protocols:<br>replacing single and multiple missing teeth in the mandible and maxilla, immediate placement in extraction sites and in situations with a partially<br>or completely healed alveolar ridge, especially indicated for use in soft bone applications where implants with<br>other implant surface treatments may be less effective, immediate loading in all indications, except in single tooth situations on<br>implants shorter than 8 mm or in soft bone (type IV) where implant<br>stability may be difficult to obtain and immediate loading may not be<br>appropriate. The intended use for OsseoSpeed™ Plus 3 .OS is limited to replacement of<br>maxillary lateral incisors and mandibular incisors.<br><br>Abutments:<br>Astra Tech Implant System Plus abutments are intended to be used in<br>conjunction with Astra Tech Implant System Plus in fully edentulous or<br>partially edentulous maxillary and/or mandibular arches to provide support<br>for crowns, bridges or overdentures.<br><br>Atlantis Abutments:<br>The Atlantis™ Abutment is intended for use with an endosseous implant to<br>support a prosthetic device in a partially or completely edentulous patient. It<br>is intended for use to support single and multiple tooth prostheses, in the<br>mandible or maxilla. The prosthesis can be cemented, screw retained or<br>friction fit to the abutment. The abutment screw is intended to secure the<br>abutment to the endosseous implant.<br><br>The Atlantis™ Crown Abutment in Zirconia is intended for use with an<br>endosseous implant to function as a substructure that also serves as the final<br>restoration, in partially or completely edentulous patients. The prosthesis is<br>screw retained. The abutment screw is intended to secure the crown abutment<br>to the endosseous implant. | Inclusive Mini Implants are self-tapping threaded titanium screws indicated<br>for long-term applications. Inclusive Mini Implants may also be used for<br>provisional applications. These devices will allow immediate loading and<br>long-term stabilization of dentures and provisional stabilization of dentures<br>while standard implants heal. To be used for immediate loading only in the<br>presence of primary stability and appropriate occlusal loading. | |
| | | Subject Device | Primary Predicate | Reference Device |
| Comparison | | K190552<br>JJ Implant System<br>JJ Implants | K142260<br>Nobel Active®<br>Nobel Biocare USA, LLC | K120414<br>OsseoSpeed™ Plus<br>Astra Tech AB |
| Intended Use | | Functional and esthetic rehabilitation of the edentulous maxilla<br>and mandible | Functional and esthetic rehabilitation of the edentulous maxilla<br>and mandible | Functional and esthetic rehabilitation of the edentulous maxilla<br>and mandible |
| Reason for Predicate/<br>Reference Device | | Not applicable | Predicate for subject Genesis Active implant design | Reference for subject Genesis Normo implant design;<br>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)…