(276 days)
No
The summary describes dental implants and associated components, with no mention of AI, ML, image processing, or any computational analysis of data. The performance studies focus on material properties and mechanical strength.
Yes
The device is described as an implant system used for "functional and esthetic rehabilitation" and "denture stabilization," indicating its therapeutic purpose to restore function and appearance.
No
Explanation: The device is an implant system used for supporting dental restorations, not for diagnosing medical conditions.
No
The device description clearly states it comprises endosseous root-form dental implants and associated hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being placed in the body (maxillary or mandibular arch) to provide support for dental restorations. This is a therapeutic and structural function, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description details endosseous root-form dental implants and associated components, which are physical implants designed to be surgically placed.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
Therefore, the JJ Implant System is a medical device, specifically a dental implant system, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
DZE, NHA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary or mandibular arch
anterior mandible and the anterior maxilla
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 ; 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 evaluate residual materials from the blasting or cleaning operations present on the final devices. No clinical data were included in this submission.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
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.
1
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
2
Indications for Use
510(k) Number (if known)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff @fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
4
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 ; 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
5
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.
6
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.
7
Comparison of Indications for Use Statements
| Subject Device | Primary Predicate | Reference Device | Reference Device | |
|---|---|---|---|---|
| K190552 | ||||
| JJ Implant System | ||||
| JJ Implants | K142260 | |||
| Nobel Active® | ||||
| Nobel Biocare USA, LLC | K120414 | |||
| OsseoSpeed™ Plus | ||||
| Astra Tech AB | K100932 | |||
| Inclusive Mini Implant | ||||
| Prismatik Dentalcraft, Incorporated | ||||
| 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. | NobelActive® implants are endosseous implants intended to be surgically
placed in the upper or lower jaw bone for anchoring or supporting tooth
replacements to restore patient esthetics and chewing function.
NobelActive® implants are indicated for single or multiple unit restorations in
splinted or non-splinted applications. This can be achieved by a 2-stage or
1-stage surgical technique in combination with immediate, early or delayed
loading protocols, recognizing sufficient primary stability and appropriate
occlusal loading for the selected technique.
NobelActive® 3.0 implants are intended to replace a lateral incisor in the
maxilla and/or a central or lateral incisor in the mandible.
NobelActive® 3.0 implants are indicated for single unit restorations only. | Implants:
The Astra Tech Dental Implants are intended for both one- and two-stage
surgical procedures in the following situations and with the following clinical
protocols:
replacing single and multiple missing teeth in the mandible and maxilla, immediate placement in extraction sites and in situations with a partially
or completely healed alveolar ridge, especially indicated for use in soft bone applications where implants with
other implant surface treatments may be less effective, immediate loading in all indications, except in single tooth situations on
implants shorter than 8 mm or in soft bone (type IV) where implant
stability may be difficult to obtain and immediate loading may not be
appropriate. The intended use for OsseoSpeed™ Plus 3 .OS is limited to replacement of
maxillary lateral incisors and mandibular incisors.
Abutments:
Astra Tech Implant System Plus abutments are intended to be used in
conjunction with Astra Tech Implant System Plus in fully edentulous or
partially edentulous maxillary and/or mandibular arches to provide support
for crowns, bridges or overdentures.
Atlantis Abutments:
The Atlantis™ Abutment is intended for use with an endosseous implant to
support a prosthetic device in a partially or completely edentulous patient. It
is intended for use to support single and multiple tooth prostheses, in the
mandible or maxilla. The prosthesis can be cemented, screw retained or
friction fit to the abutment. The abutment screw is intended to secure the
abutment to the endosseous implant.
The Atlantis™ Crown Abutment in Zirconia is intended for use with an
endosseous implant to function as a substructure that also serves as the final
restoration, in partially or completely edentulous patients. The prosthesis is
screw retained. The abutment screw is intended to secure the crown abutment
to the endosseous implant. | Inclusive Mini Implants are self-tapping threaded titanium screws indicated
for long-term applications. Inclusive Mini Implants may also be used for
provisional applications. These devices will allow immediate loading and
long-term stabilization of dentures and provisional stabilization of dentures
while standard implants heal. To be used for immediate loading only in the
presence of primary stability and appropriate occlusal loading. | |
| | | Subject Device | Primary Predicate | Reference Device |
| Comparison | | K190552
JJ Implant System
JJ Implants | K142260
Nobel Active®
Nobel Biocare USA, LLC | K120414
OsseoSpeed™ Plus
Astra Tech AB |
| Intended Use | | Functional and esthetic rehabilitation of the edentulous maxilla
and mandible | Functional and esthetic rehabilitation of the edentulous maxilla
and mandible | Functional and esthetic rehabilitation of the edentulous maxilla
and 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 Plus
3.0, 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 Plus
3.0, 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 Plus
3.0, 3.6, 4.2, 4.8, 5.4 (to match implant platform Ø) |
| | Mini: | Straight only; one-piece implant with
integral ball-attachment connection | | |
8
Comparison of Technological Characteristics
| Reference Device | |
|---|---|
| K100932 | |
| Inclusive Mini Implant | |
| Prismatik Dentalcraft, Incorporated | |
| lous maxilla | Functional and esthetic rehabilitation of the edentulous maxilla |
| and 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-attachment | |
| connection |
9
Comparison of Technological Characteristics
| Comparison | Subject Device | Primary Predicate | Reference Device | Reference Device | ||
|---|---|---|---|---|---|---|
| K190552 | ||||||
| JJ Implant System | ||||||
| JJ Implants | K142260 | |||||
| Nobel Active® | ||||||
| Nobel Biocare USA, LLC | K120414 | |||||
| OsseoSpeed™ Plus | ||||||
| Astra Tech AB | K100932 | |||||
| Inclusive Mini Implant | ||||||
| Prismatik Dentalcraft, Incorporated | ||||||
| Angled Abutments | Genesis Active: | Angled 15°, engaging, 1.25-3 mm GH | ||||
| (varies by body Ø) | Angled TiDesign Plus | |||||
| Angled 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 Plus | |||||
| 3.6, 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 integral | |||||
| ball-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; and | ||||
| Non-sterile; to be moist heat (steam) sterilized | Sterile by gamma irradiation; and | |||||
| Non-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 |