Who is the manufacturer of NobelActive?

Nobel Biocare AB filed the 510(k) submission for NobelActive (K142260).

What is the FDA product code for NobelActive?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for NobelActive?

510(k) clearance (submission type: Traditional).

What are the predicate devices for NobelActive?

NobelActive® Internal Connection Implant (K071370); NobelActive® 8.5 mm & 18.0 mm (K083205); NobelActive® 3.0 (K102436); NobelActive® Wide Platform (WP) (K133731).

Who can help prepare an FDA 510(k) submission like NobelActive?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NobelActive

K142260 · Nobel Biocare AB · DZE · May 11, 2015 · Dental

Device Facts

Record ID	K142260
Device Name	NobelActive
Applicant	Nobel Biocare AB
Product Code	DZE · Dental
Decision Date	May 11, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Threaded, root-form endosseous dental implants; surgically placed in upper/lower jaw bone to support prosthetic devices (artificial teeth). Features expanding taper body, double lead thread, reverse cutting flutes, and internal hex connection. Available in various diameters (3.0-5.5 mm) and lengths (6.5-18 mm). Used by dental surgeons in clinical settings. Device provides primary stability for immediate, early, or delayed loading protocols. Output is a stable anchor for dental restorations; restores patient esthetics and chewing function. Benefits include high insertion torque in various bone qualities (including soft bone) and reduced micro-motion under cyclic loading.

Clinical Evidence

Evidence includes two bench studies and multiple clinical studies/literature reviews. Bench testing validated drilling protocols and demonstrated significantly less micro-motion (p ≤ 0.05) and higher cyclic load resistance compared to controls. Clinical data from 199 implants in healed sites and 137 in extraction sites showed high success rates (96.8%-97.2% at 3 years). Literature (Irinakis and Wiebe, 2009; Demanet et al, 2011) reported survival rates of 97.9% and 99.1% respectively, confirming performance in various bone qualities including soft bone.

Technological Characteristics

Material: Commercially Pure (CP) Titanium. Surface: TiUnite. Design: Threaded, root-form, expanding taper body, double lead thread, reverse cutting flutes, internal hex connection. Dimensions: 3.0-5.5 mm diameter; 6.5-18 mm length. Energy: Mechanical (surgical placement). Connectivity: N/A. Sterilization: Standard medical device sterilization.

Indications for Use

Indicated for patients requiring single or multiple unit tooth replacements in upper or lower jaw. NobelActive® 3.0 implants indicated for single unit replacement of maxillary lateral incisors or mandibular central/lateral incisors. Suitable for 1-stage or 2-stage surgical techniques with immediate, early, or delayed loading protocols, provided sufficient primary stability and appropriate occlusal loading are achieved.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

NobelActive® Internal Connection Implant (K071370)
NobelActive® 8.5 mm & 18.0 mm (K083205)
NobelActive® 3.0 (K102436)
NobelActive® Wide Platform (WP) (K133731)

Related Devices

K072980 — NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS · Nobel Biocare AB · Dec 20, 2007
K092434 — STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM · Sterngold · Nov 10, 2009
K092555 — UNO NARROW IMPLANT · Mis Implants Technologies , Ltd. · Jan 5, 2010
K050406 — NOBELSPEEDY IMPLANTS · Nobel Biocare AB · Jun 8, 2005
K123022 — NEODENT IMPLANT SYSTEM · Jjgc Industria E Comercio DE Materiais Dentarios S · May 17, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ 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. 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}------------------------------------------------ ## A.4. ## 510(k) Summary K142260 #### 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. --------This section intentionally left blank--------- {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.