Kontact Dental Implant System
Device Facts
| Record ID | K210220 |
|---|---|
| Device Name | Kontact Dental Implant System |
| Applicant | Biotech Dental, Sas |
| Product Code | DZE · Dental |
| Decision Date | Jun 18, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
Kontact™ Dental Implant System is indicated for use in partially or fully edentulous patients to support maxillary or mandibular single unit, multiple-unit, or overdenture dental restorations. Kontact Dental Implant System is indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate. Kontact 3 mm diameter implants and prosthetics components are indicated for use in surgical and restorative applications in the maxillary lateral incisor or mandibular incisor regions.
Device Story
Kontact Dental Implant System comprises endosseous root-form dental implants, abutments, and associated screws; used for single-unit, multi-unit, and overdenture restorations. Implants feature internal indexing and threaded sections for abutment attachment; surface grit-blasted with non-resorbable aluminum oxide to facilitate osseointegration. Components include cover screws, healing caps, and various abutment types (straight, angled, conical, ball, etc.). Used in clinical dental settings by trained professionals. Implants are titanium alloy; select components use cobalt alloy or PEEK/PMMA. Output is a stable foundation for dental prostheses, restoring chewing function. Benefits include improved patient quality of life through tooth replacement. Device is provided sterile or non-sterile (requiring end-user sterilization).
Clinical Evidence
Bench testing only. No clinical data included. Non-clinical evidence includes gamma/moist heat sterilization validation (ISO 11137, ISO 17665), bacterial endotoxin testing (ANSI/AAMI ST72), shelf life/packaging stability (ASTM F1980, ISO 11607), biocompatibility (ISO 10993), and static/fatigue compression testing (ISO 14801). Surface characterization performed via SEM and EDS.
Technological Characteristics
Endosseous root-form dental implants and abutments. Materials: Titanium alloy (ASTM F136, ISO 5832-3), Cobalt alloy (ASTM F1058, ISO 5832-7), PEEK, PMMA. Surface: Grit-blasted with Al2O3. Connection: Internal anti-rotational. Sterilization: Gamma irradiation or moist heat. Coatings: TiN and CrN via PVD. No software/algorithm.
Indications for Use
Indicated for partially or fully edentulous patients requiring maxillary or mandibular single-unit, multiple-unit, or overdenture dental restorations. Supports immediate loading given sufficient primary stability and appropriate occlusal loading. 3 mm diameter implants/components restricted to maxillary lateral incisor or mandibular incisor regions.
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
- OsseoSpeed™ Plus (K120414)
Reference Devices
- AnyOne™ Internal Implant System (K123988)
- Ankylos SynCone® Abutment 5° (K131644)
- GPS® Angled Abutments (K153509)
- Neodent Implant System - GM Line (K163194)
- S.I.N. Dental Implant System (K170392)
- AnyRidge Octa 1 Implant System (K182448)
- ST Internal Implant System (K192347)
- S.I.N. Dental Implant System (K200992)
- PURE Ceramic Implants (K151328)
- A.B. Dental Devices® Dental Implants System (K181381)
- Preat Abutments (K183518)
- Z5-BL (K200386)
- ST Internal Fixture System (K152787)
- Low Profile Abutment (K092341)
- Straumann TLX Novaloc and Cementable Abutments (K203355)
Related Devices
- K171197 — Zuga Dental Implant System · Zuga Medical, Inc. · Jun 30, 2018
- K061500 — SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS · Sic Invent AG · Aug 8, 2006
- K112440 — AB DENTAL DEVICES IMPLANTS AND ACCESSORIES · A.B. Dental Devices , Ltd. · Apr 18, 2012
- K163640 — QZA and RS Dental Implant Systems · Trinon Titanium GmbH · May 3, 2017
- K190919 — ST Internal Implant System · T-Plus Implant Tech. Co., Ltd. · Feb 27, 2020
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Biotech Dental, SAS % Kevin Thomas Vice President and Director of Regulatory Affairs PaxMed International. LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K210220
Trade/Device Name: Kontact™ Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 17, 2021 Received: May 18, 2021
Dear Kevin Thomas:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known)
Device Name Kontact™ Dental Implant System
#### Indications for Use (Describe)
Kontact™ Dental Implant System is indicated for use in partially or fully edentulous patients to support maxillary or mandibular single unit, multiple-unit, or overdenture dental restorations. Kontact Dental Implant System is indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate. Kontact 3 mm diameter implants and prosthetics components are indicated for use in surgical and restorative applications in the maxillary lateral incisor or mandibular incisor regions.
Type of Use (Select one or both, as applicable)
| <div> <span> <span style="font-size: 20px;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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## 510(k) Summary K210220 Kontact™ Dental Implant System Biotech Dental, SAS
June 17, 2021
#### ADMINISTRATIVE INFORMATION
| Manufacturer Name | Biotech Dental, SAS | |
|---------------------------|----------------------------------------------|-----------------------|
| | 305, Allées de Craponne | |
| | 13300 Salon de Provence | |
| | France | |
| | Telephone: | +33 (0) 4 90 44 60 60 |
| | Fax: | +33 (0) 4 90 44 60 61 |
| Official Contact | Delphine Mercier, Vice President, Compliance | |
| Representative/Consultant | Kevin A. Thomas, PhD | |
| | Floyd G. Larson, MS, MBA | |
| | PaxMed International, LLC | |
| | 12264 El Camino Real, Suite 400 | |
| | San Diego, CA 92130 | |
| | Telephone: | +1 858-792-1235 |
| | Fax: | +1 858-792-1236 |
| | Email: | kthomas@paxmed.com |
| | | flarson@paxmed.com |
#### DEVICE NAME AND CLASSIFICATION
| Trade/Device Name | Kontact™ Dental Implant System |
|------------------------|---------------------------------------------------------------------|
| Common Name | Implant, Endosseous, Root-Form |
| | Abutment, Implant, Dental, Endosseous |
| Regulation Number | 21 CFR 872.3640 |
| Regulation Name | Endosseous dental implant |
| Regulatory Class | Class II |
| Product Code | DZE |
| Secondary Product Code | NHA |
| Classification Panel: | Dental |
| Reviewing Office | Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory, |
| | ENT and Dental Devices) |
| Reviewing Division | Division of Health Technology 1 B (Dental Devices) |
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#### PREDICATE DEVICE INFORMATION
Primary Predicate Device K120414, OsseoSpeedTM Plus, Astra Tech AB
Reference Devices
K123988, AnyOne™ Internal Implant System, MegaGen Implant Co., Ltd K131644, Ankylos SynCone® Abutment 5°, Dentsply International, Incorporated K 153509, GPS® Angled Abutments, Implant Direct Sybron Manufacturing, LLC K163194. Neodent Implant System - GM Line. JJGC Industria e Comercio de Materiais Dentarios SA K 170392, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. K182448, AnyRidge Octa 1 Implant System, MegaGen Implant Co., Ltd K192347, ST Internal Implant System, MegaGen Implant Co., Ltd K200992, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. K151328, PURE Ceramic Implants, Straumann, USA K181381, A.B. Dental Devices® Dental Implants System, A.B. Dental Device Ltd. K183518, Preat Abutments, Preat Corporation K200386, Z5-BL, Z-Systems AG K152787, ST Internal Fixture System, T-Plus Implant Tech. Co., Ltd. K092341, Low Profile Abutment, Biomet 3i, Inc. K203355, Straumann TLX Novaloc and Cementable Abutments, Institut Straumann AG
#### INDICATIONS FOR USE STATEMENT
Kontact™ Dental Implant System is indicated for use in partially or fully edentulous patients to support maxillary or mandibular single unit, multiple-unit, or overdenture dental restorations. Kontact Dental Implant System is indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate. Kontact 3 mm diameter implants and prosthetics components are indicated for use in surgical and restorative applications in the maxillary lateral incisor or mandibular incisor regions.
#### SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to obtain marketing clearance for Kontact™ Dental Implant System which comprises endosseous root-form dental implants, abutments, abutment screws, and other associated components for single-unit, multi-unit, and overdenture restorations.
Kontact dental implants are provided in five body diameters: 3.0 mm, 4.2 mm, 4.8 mm, and 5.4 mm. The platform diameter for each size is the same as the (maximum) body diameter. The implants are provided in lengths ranging from 8 mm to 16 mm. The subject device dental implants are summarized on the following page.
The implants have a recessed internal section for abutment indexing, and an internal threaded section for mating to the corresponding subject device cover screw, or abutment screw. All implants are manufactured from titanium alloy conforming to ASTM F136 and ISO 5832-3. The endosseous threaded surface of the subject device implants is grit-blasted with non-resorbable aluminum oxide (Al2O3) particles. This rough surface provides an increase in total contact area of the implant surface to facilitate osseointegration.
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| | Body Diameter (mm) | Lengths (mm) |
|-------------------------|--------------------|-------------------|
| Kontact Dental Implants | 3.0 | 10, 12, 14 |
| | 3.6 | 8, 10, 12, 14, 16 |
| | 4.2 | 8, 10, 12, 14, 16 |
| | 4.8 | 8, 10, 12, 14 |
| | 5.4 | 8, 10, 12, 14 |
#### Kontact™ Dental Implant Sizes
Kontact conventional and prosthetic components include cover screws, abutment screws, temporary abutments, straight abutments, angled abutments, prepable abutments, multi-unit abutments, healing caps, and overdenture abutments. The Kontact abutment and prosthetic components are summarized in the following table.
| | Coronal Ø, mm | Angle, ° | Material |
|----------------------------------|---------------------------|-------------|---------------------------------|
| Cover Screws | 2.5 - 2.9 | n/a | Titanium Alloy |
| Healing Screws | 4.1 - 7.1 | n/a | Titanium Alloy |
| Abutment Screws | 2.0 | n/a | Titanium Alloy,<br>Cobalt Alloy |
| | Prosthetic Platform Ø, mm | | |
| Temporary Abutments | 4.0 - 4.5 | n/a | Titanium Alloy |
| Non-Scalloped Straight Abutments | 3.7 - 6.5 | n/a | Titanium Alloy |
| Scalloped Straight Abutments | 3.8 - 6.6 | n/a | Titanium Alloy |
| Non-Scalloped Angled Abutments | 3.7 - 6.5 | 7.5, 15, 22 | Titanium Alloy |
| Scalloped Angled Abutments | 3.8 - 6.6 | 7.5, 15, 22 | Titanium Alloy |
| FitPost Abutment | 5.1 - 6.6 | n/a | Titanium Alloy |
| NanoPost Straight Abutments | 4.3 - 5.5 | n/a | Titanium Alloy |
| NanoPost Angled Abutments | 4.3 | 7.5, 15 | Titanium Alloy |
| NanoPost Healing Caps | 4.3 - 5.5 | n/a | PMMA |
| UniPost Abutments | 4.0 - 6.5 | n/a | Titanium Alloy |
| UniPost Healing Caps | 4.0 - 6.5 | n/a | PEEK |
| Straight Conical Abutments | 4.0 - 4.9 | n/a | Titanium Alloy |
| Angled Conical Abutments | 4.0 - 4.9 | 17 | Titanium Alloy |
| Conical Healing Caps | 4.0 - 4.9 | n/a | PEEK |
| IsoPost Straight Abutments | 4.1 | n/a | Titanium Alloy |
| IsoPost Angled Abutments | 4.1 | 7.5, 15, 22 | Titanium Alloy |
| IsoPost Healing Caps | 4.9 -5.3 | n/a | PEEK, PMMA |
| Ball Abutments | n/a | n/a | Titanium Alloy |
#### Kontact™ Screws, Abutments, and Healing Caps
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Most device screws and all subject device abutments are manufactured from titanium alloy conforming to ASTM F136 and ISO 5832-3. Select subject device abutments and screws manufactured from ttannum alloy are anodized using standard electrolytic passivation processing to impart a distinctive surface color. No dyes or color additives are used to impart color on the subject devices. All subject device screws and abutments corresponding to the subject device 3 mm diameter implants are anodized yellow. All other color-coded subject device components are anodized magenta, orange, green, blue, or brown.
The subject device abutment screw intended for 3 mm diameter implants and the prosthesis screw intended for conical abutments are manufactured from cobalt alloy, conforming to ASTM F1058 and ISO 5832-7. The abutment screw is coated with titanium nitride (TiN); the prosthesis screw is coated with chromium nitride (CrN). The coatings are created in a physical vapor deposition (PVD) process.
Subject device healing caps intended for use with UniPost abutments, and IsoPost abutments are manufactured from polyetheretherketone (PEEK). Subject device healing caps intended for NanoPost abutments and IsoPost abutments are manufactured from polymethyl methacrylate (PMMA).
#### PERFORMANCE DATA
The subject device was evaluated and tested as recommended in the FDA guidance documents Root Form Endosseous Dental Implants and Endosseous Dental Implant Abutments (issued May 12, 2004), Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (issued September 4, 2020), Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (issued March 17, 2015), Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile (issued January 21, 2016), and Pyrogen and Endotoxins Testing: Ouestions and Answer (issued June 2012).
Non-clinical data submitted to demonstrate substantial equivalence included: gamma sterilization validation for subject device implants and cover screws according to ISO 11137-1 and ISO 11137-2: bacterial endotoxin (BET) testing including Limulus amebocyte lysate (LAL) test according to ANSI/AAMI ST72 and USP 43-NF38:2020 <85>; shelf life validation through packaging stability per ASTM F1980 and in conformance with ISO 11607-1; moist heat sterilization (to be performed by the end-user) according to ISO 17665-1 and ISO TS 17665-2; biocompatibility according to ISO 10993-5 and ISO 10993-12; and static compression and compression fatigue testing according to ISO 14801.
The endosseous threaded surface of the subject device implants is grit-blasted with non-resorbable aluminum oxide (Al2O3) particles; this surface was validated by scanning electron microscope (SEM) and energy dispersive X-ray spectroscopy (EDS) characterization.
Bacterial endotoxins in the subject devices provided sterile to the end user will be monitored and controlled by measuring BET levels using a monthly sampling plan to ensure that the BET level meets the level of ≤ 20 EU/ device.
No clinical data were included in this submission.
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#### EQUIVALENCE TO MARKETED DEVICES
The subject devices are substantially equivalent in indications and design principles to the primary predicate device and reference devices listed above. Provided at the end of this summary is a table comparing the Indications for Use Statements and tables comparing the technological characteristics of the subject device, the primary predicate device, and the reference devices.
The Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of the primary predicate device K120414 and the reference devices. Slight differences in the language of the IFUS do not affect the intended use as an endosseous dental implant and dental implant abutments for support of a prosthesis to restore chewing function.
Minor differences between the IFUS for the subject device and the primary predicate device K120414 are listed below. These minor differences do not raise new questions of safety or effectiveness because the IFUS express equivalent intended use.
The predicate device IFUS states that the "The Astra Tech Dental Implants are intended for ... immediate loading in all indications, except single tooth situations on implants shorter than 8 mm, or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may be appropriate." The subject device IFUS does not provide an exception for implant lengths shorter than 8 mm because the subject device implants range from 8 mm to 16 mm. Therefore, the exception is not applicable. The subject device IFUS states that "Kontact Dental Implant System is indicated for immediate loading when good primary stability is achieved and occlusal loading is appropriate." This statement is inclusive of soft bone (type IV).
Similarly, the subject device IFUS states more concisely, the primary predicate IFUS that " ... Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: • replacing single and multiple missing teeth in the mandible and maxilla . immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge • especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective" with the sentence "Kontact Dental Implant System is indicated for use in partially or fully edentulous patients to support maxillary or mandibular single unit, multiple-unit, or overdenture dental restorations."
The predicate device IFUS states that "The intended use for OsseoSpeed™ Plus 3.0S is limited to replacement of maxillary lateral incisors and mandibular incisors." The subject device IFUS states that "Kontact 3 mm diameter implants and prosthetics components are indicated for use in surgical and restorative applications in the maxillary lateral incisor or mandibular incisor regions." The specification of "implants and prosthetic components" and "in surgical restorative applications" in the subject device IFUS is the same intended use compared to the more generic suggestion in the predicate device IFUS.
The predicate IFUS for the Atlantis Abutments is the same intended use as the subject device IFUS for the Kontact Dental Implant System includes both the subject device implants and the subject device prosthetic components.
The subject device does not include any patient-specific abutments or crowns fabricated using CAD-CAM technology; therefore, the subject device IFUS does not have an equivalent statement to the Atlantis™ Crown Abutment.
Minor differences between the IFUS for the subject device and the reference devices K123988, K182448, and K192347 are listed below. These minor differences do not raise new questions of safety or effectiveness because IFUS express equivalent intended use.
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The reference device IFUS includes the terms "Crown, bridges, and overdentures" and the subject device IFUS uses alternative terminology "single-unit, multiple-unit, and overdenture dental restorations".
The reference device IFUS states "Smaller implants (less than Ø 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading". The subject device IFUS does not define implants with a diameter less than 6.0 mm as "smaller" or implants with a diameter 6.0 mm or greater as "larger" because the subject device implants are not provided in diameters greater than 5.4 mm. Therefore, the sentence "Kontact Dental Implant System is indicated for immediate loading when good primary stability is achieved and the occlusal loading is appropriate" in the subject device IFUS is equivalent to the reference device's "smaller implants" and a restriction on "larger" implants is not applicable
Conversely, the subject device IFUS includes a restriction on 3.0 mm diameter implants and the compatible prosthetic components to the maxillary lateral incisor and mandibular incisor regions. The reference device IFUS does not include the restriction because the smallest diameter reference device is 4.0 mm.
The reference device IFUS and the subject device IFUS include different tradenames.
Minor differences between the IFUS for the subject device and the reference device K131644 are listed below. These minor differences do not raise new questions of safety or effectiveness because the IFUS express equivalent intended use.
The reference device IFUS includes reference to edentulous mandible supported by 4 ANKYLOS® implants of at least 11 mm in length and placed interforaminally which is not applicable to the subject device IsoPost abutments.
The reference device IFUS and the subject device IFUS include different tradenames.
Minor differences between the IFUS for the subject device and the reference device K153509 are listed below. These minor differences do not raise new questions of safety or effectiveness because both IFUS express equivalent intended use.
The reference device IFUS and the subject device IFUS include different tradenames.
The reference device IFUS is limited to abutments for multi-unit bridge or overdenture that are compatible with original equipment manufacturer (OEM) implant systems. The subject device IFUS does not include compatible OEM implant systems because the subject devices and accessories are not compatible with any previously cleared dental implants or prosthetic components. Additionally, the subject device IFUS specifies the Kontact Dental Implant System, which encompasses implants, abutments, and accessories.
Minor differences between the IFUS for the subject device and the reference device K163194 are listed below. These minor differences do not raise new questions of safety or effectiveness because both IFUS express equivalent intended use.
The reference device IFUS includes indications for titanium base abutments and PEEK abutments. The subject device IFUS does not include these indications because the subject device product list does not include components that are indicated for use with CAD-CAM technology or abutments manufactured from PEEK. Subject device components manufactured from PEEK are limited to healing caps.
The reference device IFUS and the subject device IFUS include different tradenames.
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Minor differences between the IFUS for the subject device and the reference device K170392 are listed below. These minor differences do not raise new questions of safety or effectiveness because both IFUS express equivalent intended use.
The reference device IFUS specifies that "Implants with lengths less than 7 mm are intended for delayed loading only." The subiect device IFUS does not restrict implant lengths less than 7 mm for delayed loading only because the subject device implants range from 8 mm to 16 mm. Therefore, the restriction is not applicable.
The reference device IFUS and the subject device IFUS include different tradenames.
Minor differences between the IFUS for the subject device and the reference device K183518 are listed below. These minor differences do not raise new questions of safety or effectiveness because both IFUS express equivalent intended use.
The reference device IFUS and the subject device IFUS include different tradenames.
The reference device IFUS includes indications for titanium blanks and titanium base abutment, refences to validated milling centers, and compatible OEM implant systems. The subject device IFUS does not include these elements because the subject device does not include components that are indicated for use with CAD-CAM technology to fabricate patient-specific abutments prescribed by the clinician. Furthermore, the subject device and accessories are not compatible with any previously cleared dental implants or prosthetic components.
Minor differences between the IFUS for the subject device and the reference devices K152787, K092341, and K203355 include: only K152787 includes language regarding implants, and does not include any limitations for small diameter implants; K152787 and K092341 do not mention specific types of restorations (single-unit, multi-unit, or overdentures); and K203355 mentions only dentures. These minor differences do not raise new questions of safety or effectiveness because both IFUS express equivalent intended use.
Last, the differences in IFUS for K151328, K181381, and K200386 are not applicable for the assessment of substantial equivalence in terms of intended use because these are reference devices for materials and modified surface information.
#### Subject Device Dental Implants
The subject device Kontact dental implants are similar in designs and sizes to OsseoSpeed™ Plus implants cleared in the primary predicate K120414. The subject device implants are provided in body diameters of 3.0 mm, 3.6 mm, 4.2 mm, and 5.4 mm. The subject device implants are provided in total lengths ranging from 8 mm to 16 mm. The primary predicate device implants are provided in body diameters of 3.0 mm, 3.6 mm, 4.2 mm, and 5.4 mm and total lengths ranging from 6 mm to 17 mm. The platform diameter for each size is the same as the (maximum) body diameter for both the subject device and the primary predicate device. Both the subject device and primary predicate device implants have an anti-rotational feature for the implant-abutment interface. Both the subject device and primary predicate device are provided sterile to the end-user.
Additionally, the subject device Kontact dental implants are manufactured from titanium alloy conforming to ASTM F136 and ISO 5832-3. Titanium alloy is commonly used to manufacture dental implants and prosthetic components. The endosseous threaded surface of the subject device is grit-blasted with non-resorbable aluminum oxide (Al2O3) particles to facilitate osseointegration. The reference device K200386 is in support of substantial equivalence for this technological characteristic
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because the endosseous threaded surface of the reference device also is modified by blasting with Al2O3 particles. Therefore, the subject device implants are substantially equivalent to the primary predicate K120414 and reference device K200386 implants.
#### Subject Device Prosthetic Components
The subject device Cover Screw and Ball Abutment designs are substantially equivalent in material and dimensions to similar devices in the primary predicate K120414.
The subject device Healing Screw designs are substantially equivalent in material and dimensions to similar healing abutments in reference devices in K123988 and K170392.
The subject device Temporary Abutment designs are substantially equivalent in material and dimensions to similar abutments in the reference devices K163194 and K192347. Similarly, the subject device UniPost Abutment designs are substantially equivalent in material and dimensions to similar abutments in the reference devices K163194, and to the EZ Post and Solid Abutments in K152787. The prosthetic post height of the UniPost Abutments is substantially equivalent to the Low Profile Abutment, K092341.
The subject device Non-Scalloped Straight Abutment and Scalloped Straight Abutment designs are substantially equivalent in material and dimensions to similar abutments in the reference devices K170392 and K192347.
The subject device Non-Scalloped Abutment and Scalloped Angled Abutment designs are substantially equivalent in material and dimensions to similar abutments in the reference devices K123988, K182448, and K200992.
The subject device FitPost Abutments are substantially equivalent in intended use, material, and designs to the reference device Milling Abutment in K192347 and K182448, and to the Solid Abutments in K152787.
The subject device NanoPost Straight Abutments, NanoPost Angled Abutments, and Conical Abutments are substantially equivalent in material, design, and dimensions to similar abutments in the reference device K182448, and to the Low Profile Abutments, K092341.
The subject device IsoPost Abutments are substantially equivalent in material, design, and dimensions to the reference device K131644 and K153509, and to the Straumann TLX Novaloc Abutments in K203355.
Mechanical performance testing of the subject device was performed in conformance to ISO 14801. The reference device K183518 is to support substantial equivalence of the fatigue limit for subject device abutments compatible with the subject device 3.0 mm diameter implants. The fatigue limit data demonstrated that constructs of all other subject device abutments in combination with all other subject device implants have sufficient strength for their intended use.
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#### CONCLUSION
The subject device, the primary predicate device, and the reference devices have the same intended use, have similar technological characteristics, and are materials. The subject device, the primary predicate, and reference devices encompass the same range of physical dimensions, are packaged in similar materials, and are to be sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
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## Comparison of Indications for Use Statements
| Subject Device | Indications for Use Statement | |
|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Kontact Dental Implant System<br>Biotech Dental, SAS | Kontact™ Dental Implant System is indicated for use in partially or fully edentulous patients to support maxillary or mandibular single unit, multiple-unit, or occlusal<br>loading when good primary stability is achieved and the occlusal loading is appropriate. Kontact 3 mm diameter implants and prosthetics components are indicated for<br>mandibular incisor regions. | |
| Primary Predicate Device | | |
| K120414<br>OsseoSpeed™ Plus<br>Astra Tech AB | The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:<br>replacing single and multiple missing teeth in the mandible and maxilla, immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge, especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective, immediate loading in all indications, except in single tooth situations on implants shorter than 8 mm, or in soft bone (type IV) where implant stability may be marginal. The intended use for OsseoSpeed™ Plus 3.0S is limited to replacement of maxillary lateral incisors and mandibular incisors. | |
| | Abutments:<br>Astra Tech Implant System Plus abutments are intended to be used in conjunction with Astra Tech Implant System Pius in fully edentulous or partially edentulous<br>overdentures. | |
| | Atlantis Abutments:<br>The Atlantis™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous; patient. It is intended that the<br>prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. | |
| | The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous; implant to function as a substructure that also serves as the final restoration. The<br>abutment screw is intended to secure the crown abutment to the endosseous implant. | |
| Reference Devices | | |
| K123988<br>AnyOne™ Internal Implant System<br>MegaGen Implant Co., Ltd | The AnyOne™ Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for<br>individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0 mm) are dedicated for immediate loading when good primary stability in the<br>molar region and are indicated for delayed loading. | |
| K131644<br>Ankylos SynCone® Abutment 5°<br>Dentsply International, Incorporated | SynCone® Abutments on osseointegrate Implants<br>Anchorage of dentures retained by taper friction and supported by ANKYLOS® implants. | |
| | SynCone® Abutments for Immediate loading<br>Immediate loading of an implant supported prosthesis in an edentulous mandible supported by 4 ANKYLOS® implants of at least 11 mm in length and placed in the mandible. | |
| K153509<br>GPS® Angled Abutments<br>Implant Direction Sybron Manufacturing LLC | GPS® Angled Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially or completely edentulous<br>overdenture. Abutments are intended for use in the mandible or maxilla. Implants can be indicated for immediate loading when good primary stability has been achieved. | |
| | Compatibility:<br>Legacy System: Prosthetically compatible with Zimmer Dental Tapered Screw-Vent system 3.5mm platform implants (3.7mmD, 4.1mmD, 8mm-16mm Length, 4.5mmD, 5.0mmD)<br>(6.0mmD, 8mm-16mm Length).<br>SwishTapered System: Prosthetically compatible with Straumann Standard and Standard Plus system RN platform implants (3.3mmD-4.8mmD, 6mm-16mm Length).<br>SwishActive Implants: SwishActive implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActive™<br>RP (Regular Platform - 3.4mm diameter) titanium abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection NobelActive™<br>NobelActive™ RP (Regular Platform - 3.4mm diameter) (3.5-5.0mmD, 8.5- 18mmLength).<br>InterActive System: InterActive implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActive™<br>Platform - 3.4mm diameter) titanium abutments. InterActive 3.0 and 3.4mm abutments are prosthetically compatible with Nobel Biocare conical connection NobelActive™<br>Platform - 3.4mm diameter) (3.5-5.0mmD, 8.5- 18mmLength) implants. | |
| K163194<br>Neodent Implant System - GM Line<br>JJGC Industria e Comercio de Materiais Dentarios SA | Indications for Use for GM implants and conventional abutments:<br>The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth,<br>for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. | |
| | Indications for Use for GM Titanium Base abutments:<br>Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping for cement-retained<br>restorations, or screw-retained single restorations.<br>All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment System are intended to be sent to Straumann for manufacture and distribution. | |
| | Indications for Use for GM Pro Peek Abutments:<br>The Pro PEEK Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months. They can be used to enhance<br>stability. | |
| K170392<br>S.I.N. Dental Implant System<br>S.I.N. - Sistema de Implante Nacional S.A. | S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When appropriate, it can be<br>loaded when good primary stability is achieved and with appropriate occlusal loading. Implants with lengths less than 7 mm are intended for delayed loading only. | |
| | Indications for Use Statement | |
| K182448<br>AnyRidge Octa 1 Implant System<br>MegaGen Implant Co., Ltd | The AnyRidge Octa 1 Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridge, and dentures) in fully and partially edentulous<br>individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:<br>- Delayed loading.<br>- Immediate loading when good primary stability is achieved and with appropriate occlusal loading.<br>Larger implants are dedicated for the molar region. | |
| K192347<br>ST Internal Implant System<br>MegaGen Implant Co., Ltd | The ST Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridge, and dentures) in fully and partially edentulous<br>individuals. It is used to restore a patient's chewing function. Smaller implants (less than 06.0mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The implants placed in the<br>molar region and are indicated for delayed loading. | |
| K200992<br>S.I.N. Dental Implant System<br>S.I.N. - Sistema de Implante Nacional S.A. | S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage approach is applied, implants can be immediately<br>loaded when good primary stability is achieved and with appropriate occlusal loading. | |
| Reference Devices | | |
| K151328<br>PURE Ceramic Implants<br>Straumann USA | The Straumann® PURE Ceramic Implant (Monotype) is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw. The prosthetic restorations used are similar in size and shape<br>to the implants through the corresponding components.<br>The Ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.<br>The Straumann® PURE Ceramic Implant Protective Cap is intended to protect the Straumann® PURE Ceramic Implant (Monotype) during the healing phase after implant placement for up to 30 days.<br>Temporary copings are intended to serve as a base for temporary crown or bridge restoration for the Straumann® PURE Ceramic Implant (Monotype) for up to 30 days. | |
| K181381<br>A.B. Dental Devices® Dental Implants System<br>A.B Dental Device Ltd | A.B. DENTAL DEVICES® 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 restorations and to restore a<br>patient's chewing function. A.B. DENTAL DEVICES® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | |
| K183518<br>Preat Abutments,<br>Preat Corporation | Preat Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. These are prefabricated<br>parts. Specifically, the titanium base and mesostructured components make up a two-piece abutment. All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Preat Abutments must be<br>validated milling center for manufacture. | |
| | Compatible Implant System | Implant Body Diameter (mm) / Implant Platform Diameter (mm) |
| | 3i OSSEOTITE® Certain® | 3.25 / 3.4 |
| | | 4.0 / 4.1 |
| | | 5.0 / 5.0 |
| | | 6.0 / 6.0 |
| | Astra Tech OsseoSpeed™ | 3.0 / 3.0 |
| | | 3.5, 4.0 / 3.5/4.0 |
| |…
