(270 days)
No
The device description and performance studies focus on the mechanical properties and clinical outcomes of a dental implant, with no mention of AI or ML technology.
Yes
The device is a dental implant used to restore patient esthetics and chewing function by anchoring tooth replacements, which directly addresses a health condition (missing teeth) and improves physiological function.
No
This device is a dental implant used to restore patient esthetics and chewing function by anchoring tooth replacements. It is a treatment device, not a diagnostic one.
No
The device description clearly states that the device is a threaded, root-form dental implant, which is a physical hardware component intended for surgical placement.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the NobelActive® implants are surgically placed in the jaw bone to support tooth replacements. This is a surgical procedure performed directly on a patient's body.
- Device Description: The device is described as a threaded, root-form dental implant, which is a physical object implanted into the bone.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
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 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 incisor in the mandible.
NobelActive® 3.0 implants are indicated for single unit restorations only.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
Nobel Biocare's NobelActive® implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients. They are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The NobelActive® implants are available in diameters 3.0, 3.5, 4.3, 5.0, and 5.5 mm. They are available in lengths between 6.5 mm to 18 mm depending upon implant diameter.
This premarket notification is being submitted to support labeling changes. No additional implants are being introduced.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw bone; maxilla; mandible
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)
Two bench studies were conducted to demonstrate performance of the subject device.
The first study validated the recommended drilling protocols by placing implants in various bone surrogates. Results support that the implant (4.3x13 mm) was fully seated in a Type 3 bone surrogate at 55 N cm when using a 2.8/3.2 as the last drill. The implant was fully seated in a Type 4 bone surrogate at 45 N cm when using a 2.4/2.8 as the last drill.
The second study evaluated primary stability and micro-motion with different implant geometries and simulated bone densities (i.e. 30 pcf - Type II to III, and 20 pcf - Type III to IV per Lekholm and Zarb). After placement, the implants were subjected to sinusoidal loading intended to simulate immediate mechanical loading for approximately 3 months. NobelActive® implants exhibited significantly less micro-motion than the comparator devices in both bone surrogates (p ≤ 0.05). The study also demonstrated that the NobelActive® implants showed higher mechanical resistance to cyclic loads in a clinically relevant loading scenario.
Several clinical studies support the substantial equivalence of the subject device.
In two separate clinical studies, NobelActive® implants were placed in healed sites and in extraction sites. The classification of bone quality was done per Lekholm and Zarb by the treating surgeon according to standard methods including imaging, presurgical investigation of the site/patient, and tactile sensation. The study protocols used a 1-stage surgical procedure (i.e. no submerged healing) in combination with an immediate loading protocol. Insertion procedures were performed according to the individual needs of the site using the recommended drill protocols in the Instructions for Use.
A total of 199 NobelActive® implants were placed in healed sites (7 - Quality Type 4, 86 - Ouality Type 3, 88 - Quality Type 2, and 18 - Ouality Type 1). The mean insertion torque achieved with NobelActive® implants was 51.1 (SD 19.5) N cm in all bone qualities and 46.15 (SD 17.5) N cm in predominantly cancellous bone (Quality 3 and 4 according to Lekholm and Zarb). The study had a control group (NobelReplace), which achieved a lower mean, i.e. 41.3 (SD 11.6) N cm in all bone qualities. In cancellous bone, the control group (NobelReplace) also achieved a lower insertion torque of 39.29 (SD 8.55) N cm compared to the values achieved with NobelActive®.
137 NobelActive® implants were placed in extraction sites (2 - Quality Type 4, 70 -Ouality Type 3, 63 - Ouality Type 2, and 2 - Ouality Type 1). The mean insertion torque achieved with NobelActive® implants was 47.21 (SD 11.4) N cm in all bone qualities and 48.00 (SD 11.45) N cm in predominantly cancellous bone (Quality 3 and 4 according to Lekholm and Zarb).
Between these two studies, a total of 164 NobelActive® were placed in predominantly cancellous bone (Type III and IV) in both extraction (72 implants) and healed (93 implants) sites, of which 5 implants had failed; meaning that 97% of the implants were successful after 3 years. In healed sites, 96.8% of the implants were successful and in extraction sites 97.2% were successful. Those numbers are well in the range of usually reported values for other implants in all types of bone.
In a separate implant handling study, four (4) clinicians placed 88 implants (26 in soft bone (Type 4), 47 in medium bone (Type 3/2), and 13 in dense bone (Type 1; 2 missing values). Data from this study showed that clinicians underprepared sites in soft bone and could reach high insertion torques, most often in the range required for immediate loading (lowest reported range 30 - 40 N cm).
Irinakis and Wiebe (2009) conducted a prospective study on NobelActive® implants. Within a 13 month period, a total of 140 implants were placed in the maxilla and mandible in both extraction and grafted sites. Of these sites, 24 were classified by the investigator as being soft quality bone. The mean insertion torque achieved was 47.9 N cm, which is the exact same mean as seen in medium bone, and is slightly lower than in dense bone. The implants were successful as there was only a 2.1% failure rate (of all implants placed) during the observation period.
Demanet et al (2011) reported 3 year results of 466 implants placed in all jaw regions, of which 58 implants were in the posterior maxilla, a usually very soft bone quality. The total survival rate was 99.1% and for the posterior region it was 98.3%, leading to the assumption that the implant performed well in all jaw bone regions.
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.
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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of a human face in profile, with three overlapping profiles creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 11, 2015
Nobel Biocare AB c/o Ms. Ji Eun Hwang Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887
Re: K142260
Trade/Device Name: NobelActive® Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 7, 2015 Received: April 8, 2015
Dear Ms. Hwang:
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 device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
lina ang -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
2
Indications for Use
510(k) Number (if known) K142260
Device Name NobelActive(R)
Indications for Use (Describe)
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.
Nobel Active® implants are indicated for single or multiple unit restorations in 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 incisor in the mandible.
NobelActive® 3.0 implants are indicated for single unit restorations only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
A.4.
510(k) Summary
I. SUBMITTER
Nobel Biocare AB Vastra Hamngatan 1 Goteborg, Sweden SE-411 17
Contact Name: Ji Eun Hwang, Sr. Regulatory Affairs Manager Phone: 714-282-4800 x5030 Fax: 714-998-9348
Date Prepared: March 20, 2015
II. DEVICE
Proprietary Name: NobelActive® Common or Usual Name: Endosseous Dental Implant Classification Name: Endosseous Dental Implant (21 CFR 872.3640) Regulatory Class: II Product Code: DZE, NHA
III. PREDICATE DEVICE
Nobel Biocare – NobelActive® Internal Connection Implant (K071370 Primary Predicate)
Nobel Biocare - NobelActive® 8.5 mm & 18.0 mm (K083205 Reference Predicate)
Nobel Biocare – NobelActive® 3.0 (K102436 Reference Predicate)
Nobel Biocare – NobelActive® Wide Platform (WP) (K133731 Reference Predicate)
IV. DEVICE DESCRIPTION
Nobel Biocare's NobelActive® implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully
4
edentulous patients. They are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The NobelActive® implants are available in diameters 3.0, 3.5, 4.3, 5.0, and 5.5 mm. They are available in lengths between 6.5 mm to 18 mm depending upon implant diameter.
This premarket notification is being submitted to support labeling changes. No additional implants are being introduced.
V. INDICATIONS FOR USE
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.
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5
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| | CHARACTERISTIC | CANDIDATE | PRIMARY
PREDICATE | REFERENCE
PREDICATE | REFERENCE
PREDICATE | REFERENCE
PREDICATE |
|----------|------------------------------------------|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | NobelActive® | NobelActive® Internal
Connection Implant
(K071370) | NobelActive® 8.5 mm &
18.0 mm (K083205) | NobelActive® 3.0
(K102436) | NobelActive® Wide
Platform (WP)
(K133731) |
| Features | Thread Design | Double lead thread
Reverse cutting flutes | Double lead thread
Reverse cutting flutes | Double lead thread
Reverse cutting flutes | Double lead thread
Reverse cutting flutes | Double lead thread
Reverse cutting flutes |
| | Implant Body
Design | Expanding Taper
Drilling blades on apex | Expanding Taper
Drilling blades on apex | Expanding Taper
Drilling blades on apex | Expanding Taper
Drilling blades on apex | Expanding Taper
Drilling blades on apex |
| | Implant Length | 7.0, 8.5, 10.0, 11.5, 13.0,
15.0, 18.0 mm | 10.0, 11.5, 13.0 mm | 8.5, 18.0 mm | 10.0, 11.5, 13.0, 15.0 mm | 7.0, 8.5, 10.0, 11.5, 13.0 mm |
| | Implant Width | 3.0, 3.5, 4.3, 5.0, 5.5
mm | 3.5, 4.3, 5.0 mm | 3.5, 4.3, 5.0 mm | 3.0 mm | 5.5 mm |
| | Connection
Type | Internal Hex | Internal Hex | Internal Hex | Internal Hex | Internal Hex |
| | Device Material | CP Titanium | CP Titanium | CP Titanium | CP Titanium | CP Titanium |
| | Surface | TiUnite | TiUnite | TiUnite | TiUnite | TiUnite |
| | Intended Use/
Principles of Operation | | Nobel Biocare's
NobelActive®
implants are
threaded, root-form
dental implants
intended for use in
the upper and/or
lower jaw to support
prosthetic devices,
such as artificial
teeth, in order to
restore patient
esthetics and
chewing function to
partially or fully
edentulous patients. | Nobel Biocare's
NobelActive® implants
are threaded, root-
form dental implants
intended for use in the
upper and/or lower
jaw to support
prosthetic devices,
such as artificial teeth,
in order to restore
patient esthetics and
chewing function to
partially or fully
edentulous patients. | Nobel Biocare's
NobelActive® implants
are threaded, root-
form dental implants
intended for use in the
upper and/or lower
jaw to support
prosthetic devices,
such as artificial teeth,
in order to restore
patient esthetics and
chewing function to
partially or fully
edentulous patients. | Nobel Biocare's
NobelActive® implants
are threaded, root-
form dental implants
intended for use in the
upper and/or lower
jaw to support
prosthetic devices,
such as artificial teeth,
in order to restore
patient esthetics and
chewing function to
partially or fully
edentulous patients. |
6
Comparison of Indications for Use
Candidate: NobelActive®
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.
Primary Predicate: NobelActive® Internal Connection Implant (K071370) Nobel
Biocare's NobelActive® implants are endosseous implants intended to be surgically placed in the bone of the upper and/or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive® implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.
Predicate: NobelActive 8.5 mm & 18.0 mm (K083205)
Nobel Biocare's NobelActive® implants are endosseous implants intended to be surgically placed in the bone of the upper and/or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive® implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive® implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.
Predicate: NobelActive 3.0 (K102436)
The NobelActive® 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisions to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelActive® 3.0 implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.
Predicate: NobelActive Wide Platform (WP) (K133731)
Nobel Biocare's NobelActive® implants are endosseous implants intended to be surgically placed in the bone of the upper and/or lower jaw arches to provide support for
7
prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive® implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive® implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
VII. PERFORMANCE DATA
Non-Clinical Data
Two bench studies were conducted to demonstrate performance of the subject device.
The first study validated the recommended drilling protocols by placing implants in various bone surrogates. Results support that the implant (4.3x13 mm) was fully seated in a Type 3 bone surrogate at 55 N cm when using a 2.8/3.2 as the last drill. The implant was fully seated in a Type 4 bone surrogate at 45 N cm when using a 2.4/2.8 as the last drill.
The second study evaluated primary stability and micro-motion with different implant geometries and simulated bone densities (i.e. 30 pcf - Type II to III, and 20 pcf - Type III to IV per Lekholm and Zarb). After placement, the implants were subjected to sinusoidal loading intended to simulate immediate mechanical loading for approximately 3 months. NobelActive® implants exhibited significantly less micro-motion than the comparator devices in both bone surrogates (p ≤ 0.05). The study also demonstrated that the NobelActive® implants showed higher mechanical resistance to cyclic loads in a clinically relevant loading scenario.
Clinical Data
Several studies support the substantial equivalence of the subject device.
In two separate clinical studies, NobelActive® implants were placed in healed sites and in extraction sites. The classification of bone quality was done per Lekholm and Zarb by the treating surgeon according to standard methods including imaging, presurgical investigation of the site/patient, and tactile sensation. The study protocols used a 1-stage surgical procedure (i.e. no submerged healing) in combination with an immediate loading protocol. Insertion procedures were performed according to the individual needs of the site using the recommended drill protocols in the Instructions for Use.
A total of 199 NobelActive® implants were placed in healed sites (7 - Quality Type 4, 86 - Ouality Type 3, 88 - Quality Type 2, and 18 - Ouality Type 1). The mean insertion torque achieved with NobelActive® implants was 51.1 (SD 19.5) N cm in all bone qualities and 46.15 (SD 17.5) N cm in predominantly cancellous bone (Quality 3 and 4 according to Lekholm and Zarb). The study had a control group (NobelReplace), which achieved a lower mean, i.e. 41.3 (SD 11.6) N cm in all bone qualities. In cancellous
8
bone, the control group (NobelReplace) also achieved a lower insertion torque of 39.29 (SD 8.55) N cm compared to the values achieved with NobelActive®.
137 NobelActive® implants were placed in extraction sites (2 - Quality Type 4, 70 -Ouality Type 3, 63 - Ouality Type 2, and 2 - Ouality Type 1). The mean insertion torque achieved with NobelActive® implants was 47.21 (SD 11.4) N cm in all bone qualities and 48.00 (SD 11.45) N cm in predominantly cancellous bone (Quality 3 and 4 according to Lekholm and Zarb).
Between these two studies, a total of 164 NobelActive® were placed in predominantly cancellous bone (Type III and IV) in both extraction (72 implants) and healed (93 implants) sites, of which 5 implants had failed; meaning that 97% of the implants were successful after 3 years. In healed sites, 96.8% of the implants were successful and in extraction sites 97.2% were successful. Those numbers are well in the range of usually reported values for other implants in all types of bone.
In a separate implant handling study, four (4) clinicians placed 88 implants (26 in soft bone (Type 4), 47 in medium bone (Type 3/2), and 13 in dense bone (Type 1; 2 missing values). Data from this study showed that clinicians underprepared sites in soft bone and could reach high insertion torques, most often in the range required for immediate loading (lowest reported range 30 - 40 N cm).
Irinakis and Wiebe (2009) conducted a prospective study on NobelActive® implants. Within a 13 month period, a total of 140 implants were placed in the maxilla and mandible in both extraction and grafted sites. Of these sites, 24 were classified by the investigator as being soft quality bone. The mean insertion torque achieved was 47.9 N cm, which is the exact same mean as seen in medium bone, and is slightly lower than in dense bone. The implants were successful as there was only a 2.1% failure rate (of all implants placed) during the observation period.
Demanet et al (2011) reported 3 year results of 466 implants placed in all jaw regions, of which 58 implants were in the posterior maxilla, a usually very soft bone quality. The total survival rate was 99.1% and for the posterior region it was 98.3%, leading to the assumption that the implant performed well in all jaw bone regions.
VII. CONCLUSION
The differences in intended use between the subject and predicate devices (primary and reference devices) are the identification of the available surgical protocols and the inclusion of all previously cleared lengths and widths of the Nobel Active family of products. These changes do not alter the intended use of the device, which is to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. The changes instead encompass and harmonize the intended use for all NobelActive family products.
9
Furthermore, the subject devices have the same design characteristics, implant to-abutment connections (3.0, NP, RP, WP), materials (CP Ti), surface treatment (TiUnite), internal hex connection, packaging and sterilization process as the identified primary and reference predicate devices. Additionally, the subject device encompasses all previously cleared dimensions of the primary and reference predicate devices.
Based on the information provided above and within this submission, the subject devices are substantially equivalent to the predicate devices.