(137 days)
Alpha-Bio Tec K063364
No
The 510(k) summary describes a system of dental implants, abutments, and surgical instruments made of titanium alloy. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies focus on mechanical testing, sterilization, shelf life, and biocompatibility, which are standard for this type of physical device.
Yes
The device is described as restoring the patient's chewing function by providing support for prosthetic devices (artificial teeth), which is a form of therapy to address a loss of function.
No
The NOVA® Dental Implants System is a prosthetic device used to replace missing teeth and restore chewing function. It is not used to diagnose a medical condition.
No
The device description clearly outlines physical components made of titanium alloy, such as dental implants, abutments, and surgical instruments. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, the NOVA® Dental Implants System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for surgical and restorative applications to provide support for prosthetic devices in the bone of the jaw to restore chewing function. This is a direct medical intervention within the body.
- Device Description: The device description details physical components like implants, abutments, and surgical instruments, all of which are used in a surgical procedure.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The NOVA® Dental Implants System does not perform this function. It is a physical implant placed within the body.
Therefore, the NOVA® Dental Implants System is a medical device used for surgical and restorative purposes, not an IVD.
N/A
Intended Use / Indications for Use
NOVA® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. NOVA® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
NOVA® Dental Implants System consists of internal hex dental implants. cover screws and healing caps; abutments system and superstructures; impression copy system & surgical instruments.
Internal hex implants:-
PSI implants are provided in diameters: 3.3, 3.75, 4.2, 5 & 6 with lengths 8, 10, 11.5, 13, & 16 mm. (16 mm is not provided for 6 mm diameter).
PCI implants are provided in diameters: 3.3, 3.75, 4.2, 5 & 6 with lengths 8, 10, 11.5, 13, & 16 mm. (16 mm is not provided for 6 mm diameter).
NOVA Dental Abutments internal hex system provides:
Healing Caps:
HC Series - Narrow (3.75 mm) - Platform height 2,3,4,5,6,7
HC Series - Standard (4.7 mm) - Platform height 2.3.4.5.6.7
HCW Series - Wide (6.00 mm) - Platform height 3,4,5,6
PMI Series - Premium (3.75, 4.7, 6.0 mm) - Platform height 2,3,4,5,6,7
Straight Abutments (Long, straight, narrow, anatomic, curve):
ST Series: Length 8.5, 9.5, 11.5, 12.5 mm.
STA Series: With Shoulder profile height 1, Length 9 mm; profile height 2, Length 10; profile height 3, Length 11; profile height 4 Length 12.
STN: Narrow length 11 mm.
SLM Series: Anatomic Straight Abutment: profile height 1,2,3 length 9,10,11 mm.
SCM Series: Anatomic Straight Abutment: profile height 1.2.3 length 9.10.11 mm.
Angulated Abutments (standard, anatomic, curve):
Standard Angulated Abutment Length 7,9,11 Angulations 15°, 25°.
Anatomic Angulated Abutments Platform height 1,2,3,4 Angulations 15°, 25°.
Anatomic Angulated Curve Platform height 1,2,3, Angulations 15°, 25°.
Ball Attachments Platform height 1.2.3.4.5.6 and related components covers and caps.
Material: NOVA® Dental Implants System and Dental Abutments System is made of Titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw, Oral Cavity
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)
Clinical Testing - No clinical data is included in this submission.
Sterilization validation tests and Shelf life testing were carried out. Test results have demonstrated that the SAL of 10-° was achieved and all testing requirements were met.
Mechanical Testing - NOVA® Implants Technologies has conducted Fatigue - Static & Cycling tests which comply with ISO 14801 Second edition 2007-11-15 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants. The results of the fatigue load testing demonstrate that the subject devices are substantially equivalent to the predicate devices.
Biocompatibility test has been performed. Test results have demonstrated no evidence of causing cell lysis or toxicity and thus present equivalent performance as its predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Alpha-Bio Tec K063364
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
SGS International K133362, A.B.Dental Devices K051719, K112440, K132125, Paltop K112795, Nobel Biocare K050705
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 29, 2015
NOVA® Implants Ltd. c/o Ms. Daniela Levy Sterling Medical Registration 22817 Ventura Blvd Woodland Hills, California 91364
Re: K150363
Trade/Device Name: NOVA® Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 13, 2015 Received: May 27, 2015
Dear Ms. Levy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for Nova Implants. The word "NOVA" is in large, bold, black letters, with a red accent mark above the "V". Below "NOVA" is the word "IMPLANTS" in red, and below that is the phrase "MEDICAL DEVICES & DEVELOPMENT" in a smaller, thinner font, also in red.
Page 1 of 1
SECTION 4 - Indication for Use Statement
| 510(k) Number (if known): | K150363 |
|---|---|
| Device Name: | NOVA ® Dental Implants System |
| Indications for Use (Describe) | |
| Indications for Use: |
NOVA® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. NOVA® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use(21 CFR 801 Subpart |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image is a logo for Nova Implants Medical Devices & Development. The word "NOVA" is in large, bold, black letters, with a red accent mark above the "V". Below "NOVA" is the word "IMPLANTS" in red, followed by the words "MEDICAL DEVICES & DEVELOPMENT" in a smaller font size and gray color.
510(k) Summary (21 CFR 807.92) SECTION 5
510(k) Number K____________
| 1 | Submission Owner | NOVA® Implants Ltd.
Dan Grimberg – CEO
5 Yoni Nethanyhu st.,
Or Yehuda ZIP 6037603
ISRAEL
Phone : +972-77-3528166
Fax : +972-54-7528166 |
|---|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Official Correspondent
Contact Person | Sterling Medical Registration
Daniela Levy - Regulatory Consultant
22817 Ventura blvd.
Woodland Hills, CA 91364
Phone: 1-213-787-3027
Email: daniela@sterlingmedicalregistration.com |
| 3 | Submission Date | June 21, 2015 |
| 4 | Device Trade Name | NOVA® Dental Implants System |
| 5 | Regulation Description | Root-form Endosseous Dental Implants and Abutments |
| 6 | Classification | Device Name : Endosseous dental implant
Product Code : DZE, NHA
Regulation No : 872.3640
Class : II
Panel : Dental |
| 7 | Reason for the Premarket Notification Submission | : New Device |
- 8 Identification of Legally Marketed Predicate Devices :
4
Image /page/4/Picture/0 description: The image shows the logo for Nova Implants Medical Devices & Development. The word "NOVA" is in large, bold, black letters. Above the "V" is a small red shape that resembles a flame or a stylized checkmark. Below "NOVA" is the word "IMPLANTS" in red, followed by "MEDICAL DEVICES & DEVELOPMENT" in a smaller, black font.
in terms of intended use, indication for use, technological characteristics, performance and user interface.
The predicate devices are a Class II medical device.
- ഗ Device Description:
NOVA® Dental Implants System consists of internal hex dental implants. cover screws and healing caps; abutments system and superstructures; impression copy system & surgical instruments.
Internal hex implants:-
PSI implants are provided in diameters: 3.3, 3.75, 4.2, 5 & 6 with lengths 8, 10, 11.5, 13, & 16 mm. (16 mm is not provided for 6 mm diameter).
PCI implants are provided in diameters: 3.3, 3.75, 4.2, 5 & 6 with lengths 8, 10, 11.5,
13, & 16 mm. (16 mm is not provided for 6 mm diameter).
NOVA Dental Abutments internal hex system provides:
Healing Caps:
HC Series - Narrow (3.75 mm) - Platform height 2,3,4,5,6,7
HC Series - Standard (4.7 mm) - Platform height 2.3.4.5.6.7
HCW Series - Wide (6.00 mm) - Platform height 3,4,5,6
PMI Series - Premium (3.75, 4.7, 6.0 mm) - Platform height 2,3,4,5,6,7
Straight Abutments (Long, straight, narrow, anatomic, curve):
ST Series: Length 8.5, 9.5, 11.5, 12.5 mm.
STA Series: With Shoulder profile height 1, Length 9 mm; profile height 2, Length 10; profile height 3, Length 11; profile height 4 Length 12.
STN: Narrow length 11 mm.
SLM Series: Anatomic Straight Abutment: profile height 1,2,3 length 9,10,11 mm.
SCM Series: Anatomic Straight Abutment: profile height 1.2.3 length 9.10.11 mm.
Angulated Abutments (standard, anatomic, curve):
Standard Angulated Abutment Length 7,9,11 Angulations 15°, 25°.
Anatomic Angulated Abutments Platform height 1,2,3,4 Angulations 15°, 25°.
Anatomic Angulated Curve Platform height 1,2,3, Angulations 15°, 25° .
5
Image /page/5/Picture/0 description: The image shows the logo for Nova Implants. The word "NOVA" is in large, bold, black letters, with a red check mark above the "V". Below "NOVA" is the word "IMPLANTS" in red letters. Underneath "IMPLANTS" is the phrase "MEDICAL DEVICES & DEVELOPMENT" in smaller, gray letters.
Ball Attachments Platform height 1.2.3.4.5.6 and related components covers and caps. Material:
NOVA® Dental Implants System and Dental Abutments System is made of Titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136.
-
10 Intended use / Indication for Use:
NOVA ® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. NOVA ® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. -
11 Performance Standards or Special Controls
- ISO 7405 Second edition 2008-12-15 Dentistry Evaluation of biocompatibility of medical devices used in dentistry.
- ISO 5832-3:1996 Implants for surgery -- Metallic materials -- Part 3: Wrought . titanium 6-aluminium 4-vanadium alloy.
- ISO 14801 Second edition 2007-11-15 Dentistry-Implants-Dynamic fatique test for . endosseous dental implants.
- FDA guidance document: Class II Special Controls Guidance Document: Root-form . Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff.
| Substantial Equivalent
| Table | Candidate No.1 | PREDICATE DEVICE |
|---|---|---|
| CHARACTERISTIC | PCI Dental Implant | ATID Internal Hex Implants |
| 510k | K063364 (primary predicate) | |
| Company Name | NOVA Implants Ltd. | Alpha-Bio Tec Ltd. |
| Indication for Use | NOVA® Dental Implants System is | |
| indicated for use in surgical and | ||
| restorative applications for placement in | ||
| the bone of the upper or lower jaw to | ||
| provide support for prosthetic devices, | ||
| such as artificial teeth, in order to restore | ||
| the patient's chewing function. NOVA® | ||
| Dental Implants System is indicated also | ||
| for immediate loading when good | ||
| primary stability is achieved and with | The Alpha-Bio Dental Implant | |
| System® is indicated for use in | ||
| surgical and restorative applications | ||
| for placement in the bone of the upper | ||
| or lower jaw to provide support for | ||
| prosthetic devices, such as artificial | ||
| teeth, in order to restore the patient's | ||
| chewing function. | ||
| Two stage: ATID, | ||
| DFI,SPI,SFB,ATIE OF, ITO, SPR | ||
| One stage: ITO, SPR | ||
| One stage and One Piece: ARRP, | ||
| appropriate occlusal loading. | ARPB, ARRC 3mmd diameter are | |
| intended only for placement at the | ||
| mandibular central and lateral incisors | ||
| and maxillary and lateral incisors. | ||
| Indicated also for denture stabilization | ||
| using multiple implants | ||
| One stage and One Piece for | ||
| temporary use: ARR, ARB, ARS, | ||
| ARSB permit immediate splint stability | ||
| for crown, bridge and prosthesis, | ||
| protect graft sites. | ||
| The Alpha-Bio Dental Implant | ||
| System® is indicated also for | ||
| immediate loading when good primary | ||
| stability is achieved and with | ||
| appropriate occlusal loading. DFI, SPI, | ||
| ARRP, ARPB. | ||
| The Alpha-Bio Dental Implant | ||
| System® is indicated also for | ||
| immediate loading on single tooth | ||
| when good primary stability is | ||
| achieved and with appropriate occlusal | ||
| loading. SPI, SFB. | ||
| All implants with diameter 3.3mmd | ||
| should not use angled abutment. | ||
| Device Design | Threaded, root form endosseous implants | Threaded, root form endosseous implants |
| Classification | Class 2 872.3640 P.Code DZE | Class 2 872.3640 P.Code DZE |
| Material | GR-5 Titanium Ti-6Al-4V ELI | GR-5 Titanium Ti-6Al-4V ELI |
| Diameters mm | 3.3, 3.75, 4.2, 5, 6 | 3.3, 3.75, 4.2, 5, 6 |
| Lengths mm | 8, 10, 11.5, 13, 16 [16 not for 6 mm] | 8, 10, 11.5, 13, 16 |
| Implant Body Contour | Straight | Straight |
| Anatomical Site | Oral Cavity | Oral Cavity |
| Principle of operation | Conventional procedure | Conventional procedure |
| Self tapping | ✓ | ✓ |
| Sterilization | Gamma Ray | Gamma Ray |
| Packaging | Double packaging | Double packaging |
| Bone preparation Procedure | Conventional drills | Conventional drills |
| Substantial Equivalent | ||
| Table | Candidate No.2 | PREDICATE DEVICE |
| CHARACTERISTIC | PSI Dental Implant | SPI Internal Hex Implants |
| 510k | K063364 | |
| (primary predicate) | ||
| Company Name | NOVA Implants Ltd. | Alpha-Bio Tec Ltd. |
| Indication for Use | NOVA® Dental Implants System is | |
| indicated for use in surgical and | ||
| restorative applications for placement in | ||
| the bone of the upper or lower jaw to | ||
| provide support for prosthetic devices, | ||
| such as artificial teeth, in order to restore | ||
| the patient's chewing function. NOVA® | The Alpha-Bio Dental Implant | |
| System® is indicated for use in | ||
| surgical and restorative applications | ||
| for placement in the bone of the upper | ||
| or lower jaw to provide support for | ||
| prosthetic devices, such as artificial | ||
| teeth, in order to restore the patient's | ||
| chewing function. | ||
| Dental Implants System is indicated also | ||
| loading when | ||
| immediate | ||
| for | ||
| good | ||
| primary stability is achieved and with | ||
| appropriate occlusal loading. | ATID. | |
| Two | ||
| stage: | ||
| DFI,SPI,SFB,ATIE OF, ITO, SPR | ||
| ITO, SPR | ||
| One stage: | ||
| One stage and One Piece: ARRP, | ||
| ARPB, ARRC 3mmd diameter are | ||
| intended only for placement at the | ||
| mandibular central and lateral incisors | ||
| and maxillary and lateral incisors. | ||
| Indicated also for denture stabilization | ||
| using multiple implants | ||
| One stage and One | ||
| Piece for | ||
| temporary use: ARR, ARB, ARS, | ||
| ARSB permit immediate splint stability | ||
| for crown, bridge and prosthesis, | ||
| protect graft sites. | ||
| Alpha-Bio | ||
| Dental | ||
| The | ||
| Implant | ||
| is indicated also for | ||
| System® | ||
| immediate loading when good primary | ||
| is achieved | ||
| stability | ||
| and | ||
| with | ||
| appropriate occlusal loading. DFI, SPI, | ||
| ARRP, ARPB. | ||
| Alpha-Bio | ||
| The | ||
| Implant | ||
| Dental | ||
| indicated | ||
| also | ||
| System® | ||
| is | ||
| for | ||
| immediate loading on single tooth | ||
| good primary stability | ||
| when | ||
| ાડ | ||
| achieved and with appropriate occlusal | ||
| loading. SPI, SFB. | ||
| All implants with diameter 3.3mmd | ||
| should not use angled abutment. | ||
| Device Design | Threaded, root form endosseous | |
| implants | Threaded, root form endosseous | |
| implants | ||
| Classification | Class 2 872.3640 | |
| P.Code DZE | Class 2 872.3640 | |
| P.Code DZE | ||
| Material | GR-5 Titanium Ti-6AI-4V ELI | GR-5 Titanium Ti-6Al-4V ELI |
| Diameters mm | 3.3, 3.75, 4.2, 5, 6 | 3.3, 3.75, 4.2, 5, 6 |
| Lengths | ||
| mm | 8, 10, 11.5, 13, 16 [16 not for 6 mm] | 8, 10, 11.5, 13, 16 |
| Implant Body Contour | Tapered | Tapered |
| Anatomical Site | Oral Cavity | Oral Cavity |
| Principle of operation | Conventional procedure | Conventional procedure |
| Self tapping | V | V |
| Sterilization | Gamma Ray | Gamma Ray |
| Packaging | Double packaging | Double packaging |
| Bone preparation Procedure | Conventional drills | Conventional drills |
12 Substantial Equivalence
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Image /page/6/Picture/0 description: The image shows the logo for Nova Implants Medical Devices & Development. The word "Nova" is in large, bold, black letters. Above the "v" is a small red diamond shape. Below "Nova" is the word "Implants" in red, and below that is the phrase "Medical Devices & Development" in smaller red letters.
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Image /page/7/Picture/0 description: The image is a logo for Nova Implants Medical Devices & Development. The word "NOVA" is in large, bold, black letters, with a red accent mark above the "V". Below "NOVA" is the word "IMPLANTS" in red, followed by the words "MEDICAL DEVICES & DEVELOPMENT" in a smaller font, also in red. The logo is clean and modern, with a focus on the company name and its area of expertise.
| Product Code: NHA Regulation No. 872.3630 | |||
|---|---|---|---|
| Candidate | Reference Predicate Device | Reference Predicate Device | |
| NOVA Implants Itd | SGS International Itd | A.B.DENTAL DEVICES | |
| Product Name | Healing Abutments (PMI) | Healing Abutments | |
| (HN,HNN,HWN) | PON | ||
| K Number | K133362 | K051719, K112440 | |
| Indication for | |||
| Use | NOVA® Dental Implants | ||
| System is indicated for use in | |||
| surgical and restorative | |||
| applications for placement in | |||
| the bone of the upper or lower | |||
| jaw to provide support for | |||
| prosthetic devices, such as | |||
| artificial teeth, in order to | |||
| restore the patient's chewing | |||
| function. NOVA® Dental | |||
| Implants System is indicated | |||
| also for immediate loading | |||
| when good primary stability is | |||
| achieved and with appropriate | |||
| occlusal loading. | SGS® Dental Implants | ||
| System is intended for | |||
| surgical placement in the | |||
| maxillary and/or mandibular | |||
| arch to support crowns, | |||
| bridges, or overdentures in | |||
| edentulous or partially | |||
| edentulous patients. SGS® | |||
| Dental Implants System may | |||
| be immediate loading when | |||
| good primary stability is | |||
| achieved and with | |||
| appropriate occlusal loading. | |||
| Two Stage Implants: P1, P7, | |||
| P7N. | |||
| One Stage: P7S, P9S. | |||
| One Stage & One-Piece 3.0 | |||
| mm diameter implants: P7S, | |||
| P9S are intended for | |||
| placement at the mandibular | |||
| central and lateral incisors | |||
| and maxillary and lateral | |||
| incisors. Indicated also for | |||
| denture stabilization using | |||
| multiple implants. | |||
| One stage & One-Piece 2.4 | |||
| mm diameter implants for | |||
| temporary use or long term | |||
| use: P9S permit immediate | |||
| splint stability and long term | |||
| fixation of new or existing | |||
| crown, bridge and prosthesis. | |||
| PEEK Temporary Abutments | |||
| are not to exceed 30 days. | The AB Dental Devices | ||
| implants are intended for | |||
| surgical' placement in the | |||
| maxillary mandibular and/or | |||
| arch to support crowns, | |||
| bridges, or overdlentures in | |||
| edlentulous or partially | |||
| edentulous patients. | |||
| 17 Integral implant, 15 | |||
| Conical implant, P15 | |||
| Temporary abutment, P12- | |||
| T,L Temporary flat | |||
| connection abutment, and | |||
| P16 Straight adaptor are | |||
| appropriate for immediate | |||
| loading when good primary | |||
| stability is achieved and with | |||
| appropriate occlusal loading. | |||
| Dimensions | Narrow, Length: 2,3,4,5,6,7 | Narrow, Length: 2,3,4 | Narrow, Length: 3, 5, 7 |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal Hex | Internal Hex | Internal Hex |
| Candidate | Reference Predicate Device | Reference Predicate Device | |
| NOVA Implants ltd | SGS International Itd | A.B.DENTAL DEVICES | |
| Product Name | Healing Abutments (HC, | ||
| HCW) | Healing Abutments (H,HN, | ||
| HW) | PO | ||
| K Number | K133362 | K051719, K112440 | |
| Dimensions | Normal, Length:2,3,4,5,6,7 | ||
| Narrow, Length: 2,3,4,5,6,7 | |||
| Wide, Length: 3,4,5,6 | Normal, Length:2,3,4,5,6 | ||
| Narrow, Length:3,5 | |||
| Wide, Length: 3,5 | Normal, Length:2,3,4,5,6,7 | ||
| Narrow, Length: 2,3,4,5,6,7 | |||
| Wide, Length: 3,4,5,6 | |||
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal Hex | Internal Hex | Internal Hex |
| Candidate | Reference Predicate Device | ||
| NOVA Implants ltd | SGS International Itd | ||
| Product Name | Ball attachment BAT | Overdenture Ball attachment | |
| K Number | K133362 | ||
| Dimensions | Normal: Length:1,2,3,4,5,6,7 | Normal: Length:1,2,3,4,5,6,7 | |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | |
| Connection | Internal Hex, overdenture rest. | Internal Hex, overdenture rest. | |
| Related Components | Metal and silicon caps | Metal and silicon caps | |
| Candidate | |||
| NOVA Implants Itd | Reference Predicate Device | ||
| SGS International Itd | |||
| Product Name | Straight Titanium Abutment ST, STN | Straight Titanium Abutment S1N,S1WN, S1,S1N,S1W | |
| K Number | K133362 | ||
| Dimensions | Normal: Length: 8.5, 9.5, 11.5, 12.5 | ||
| Narrow: Length: 9 (=with the external hex length its 11mm) | Narrow: Narrow, Wide - Length:9 | ||
| Normal: Length: 5, 7, 9, 12, 15 | |||
| Narrow: Length: 7, 9 | |||
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | |
| Connection | Internal Hex | Internal Hex | |
| Candidate | |||
| NOVA Implants Itd | Primary Predicate | ||
| Alpha-Bio Tec | |||
| Product Name | Straight Titanium Abutment STA | Straight Titanium Abutment TLA1-4, TLASP | |
| K Number | K063364 | ||
| Dimensions | Normal: Profile Height 1, 2, 3,4 mm | Normal: Profile Height 1, 2, 3,4 mm | |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | |
| Connection | Internal Hex | Internal Hex | |
| Candidate | |||
| NOVA Implants Itd | Reference Predicate Device | ||
| SGS International Itd | Reference Predicate Device | ||
| A.B. Dental Devices | |||
| Product Name | Anatomic Straight Titanium Abutment SLM, SCM | Anatomic Straight Titanium Abutment S1A | Anatomic Straight Titanium Abutment P3S |
| K Number | K133362 | K132125 | |
| Dimensions | Normal: Profile Height 1, 2, 3 mm | Normal: Profile Height 1, 2, 3 mm | Normal: Profile Height 1, 2, 3 mm |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal Hex | Internal Hex | Internal Hex |
| Candidate | |||
| NOVA Implants Itd | Reference Predicate Device | ||
| SGS International | |||
| Product Name | Angular Titanium Abutment ASM | Angular Titanium Abutment S2,S2L | |
| K Number | K133362 | ||
| Dimensions | Normal: Angle 15°, 25°- Length 7, 9, 11 mm | Normal: Angle 15°, 25°- Length 9, 11 mm | |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal Hex | Internal Hex | Internal Hex |
| Candidate | Reference Predicate Device | Reference Predicate Device | |
| NOVA Implants Itd | SGS International | Paltop | |
| Product Name | Anatomic Angular Titanium | ||
| Abutment ANG | Anatomic Angular Titanium | ||
| Abutment S2A , S2AN | Anatomic Angulated | ||
| Abutments narrow/standard | |||
| K Number | K133362 | K112795 | |
| Dimensions | Normal: Angle 15°, 25°- Profile | ||
| 1,2, 3, 4 mm | Normal: Angle 15°, 25°- Profile 1,2, 3 mm | Normal: Angle 15°, 25°- Profile 1,2, 3 mm | |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal Hex | Internal Hex | Internal Hex |
| Candidate | Reference Predicate Device | Reference Predicate Device | |
| NOVA Implants Itd | SGS International | Paltop | |
| Product Name | Anatomic Angular Titanium | ||
| Abutment ANT | Anatomic Angular Titanium | ||
| Abutment S2AN, S2AN | Anatomic Angulated | ||
| Abutments narrow/standard | |||
| K Number | K133362 | K112795 | |
| Dimensions | Normal: Angle 15°, 25°- Profile | ||
| 1,2, 3 mm | Normal: Angle 15°, 25°- Profile 1,2, 3 mm | Normal: Angle 15°, 25°- Profile 1,2, 3 mm | |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal Hex | Internal Hex | Internal Hex |
8
Image /page/8/Picture/0 description: The image shows the logo for Nova Implants. The word "NOVA" is in large, bold, black letters, with a red triangle above the "V". Below "NOVA" is the word "IMPLANTS" in red letters. Below "IMPLANTS" is the phrase "MEDICAL DEVICES & DEVELOPMENT" in smaller, gray letters.
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Image /page/9/Picture/0 description: The image is a logo for Nova Implants Medical Devices & Development. The word "NOVA" is in large, bold, black letters, with a red accent mark above the "V". Below "NOVA" is the word "IMPLANTS" in red, and below that is the phrase "MEDICAL DEVICES & DEVELOPMENT" in gray.
10
Image /page/10/Picture/0 description: The image shows the logo for Nova Implants. The word "NOVA" is in large, bold, black letters, with a red accent mark above the "V". Below "NOVA" is the word "IMPLANTS" in red. Below "IMPLANTS" is the phrase "MEDICAL DEVICES & DEVELOPMENT" in a smaller, light-blue font.
Summary of Equivalence:
NOVA® Dental Implants System shares similarity to Alpha-Bio Tec K063364 (primary predicate); in terms of intended use, indication for use, technological characteristics, performance and user interface.
NOVA® Dental Abutments System shares similarity to Alpha-Bio Tec K063364 (primary predicate); And reference predicate devices: SGS International K133362; A.B.Dental Devices K051719, K112440, K132125; Paltop K112795; Nobel Biocare K050705; in terms of intended use, indication for use, technological characteristics, performance and user interface.
NOVA® Dental Implants System shares the same raw material as its predicated devices, the only difference whereas NOVA Dental Implants provides surface treatment of sand blast with acid etched in similar to Alpha Bio Tec K063364, and also anodized surface treatment, which is similar to Nobel Biocare K050705.
As demonstrated by the substantial equivalent table, the differences raise no new issues of safety or effectiveness, since NOVA® Dental Implants System and Dental Abutments System shares similarity to its predicate devices.
Clinical Testing - No clinical data is included in this submission.
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Image /page/11/Picture/0 description: The image is a logo for Nova Implants Medical Devices & Development. The word "NOVA" is in large, bold, black letters, with a red diamond shape above the "V". Below "NOVA" is the word "IMPLANTS" in red, and below that is the phrase "MEDICAL DEVICES & DEVELOPMENT" in a smaller, lighter font, also in red.
Sterilization validation tests and Shelf life testing were carried out. Test results have demonstrated that the SAL of 10-° was achieved and all testing requirements were met. Mechanical Testing - NOVA® Implants Technologies has conducted Fatigue - Static & Cycling tests which comply with ISO 14801 Second edition 2007-11-15 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants. The results of the fatigue load testing demonstrate that the subject devices are substantially equivalent to the predicate devices.
Biocompatibility test has been performed. Test results have demonstrated no evidence of causing cell lysis or toxicity and thus present equivalent performance as its predicate devices.
Risk management process was carried out with accordance to ISO 14971:2007.
The NOVA® Implants system shares the same intended use, raw material, design, technological characteristics, warnings, contraindications as its predicate devices and thus considered to be substantially equivalent to its predicate devices.
Conclusion:
As verified by bench testing, mechanical testing, risk assessment and substantial equivalence, NOVA® Dental Implant System shares similarity with its predicated devices by term of intended use, raw material and technical design. The fundamental scientific technology of the device is identical or very similar to the referenced predicate devices, therefore NOVA® Dental Implant System is considered to be substantially equivalent to its predicate devices.