Who is the manufacturer of SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM?

Materialise Dental NV filed the 510(k) submission for SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM (K113739).

What is the FDA product code for SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM?

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

What are the predicate devices for SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM?

SimPlant® 2011 (K110300); Nobel Biocare Guided Surgery Concept (K050393); Ivoclar Vivadent - Telio CAD (K093708).

Who can help prepare an FDA 510(k) submission like SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM?

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.

SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM

K113739 · Materialise Dental NV · LLZ · May 30, 2012 · Radiology

Device Facts

Record ID	K113739
Device Name	SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM
Applicant	Materialise Dental NV
Product Code	LLZ · Radiology
Decision Date	May 30, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K113739 · May 30, 2012	SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM	Materialise Dental NV	Clinical evaluation/observational data from 11 doctors and 20 patients	The system was evaluated in a clinical setting to assess usability, aesthetic outcomes, and material adequacy. Clinical feedback was gathered from 20 patients treated by 11 doctors, with follow-up at 12 weeks to confirm safety and effectiveness.	Clinical evaluation; Usability; Aesthetic results; Routine clinical practice

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Clinical evaluation of SimPlant Immediate Smile System; Multi-center clinical evaluation; Follow-up/Duration: 12 weeks	20 patients; Sample Size: 20; Number of Sites: 11 doctors from different countries	Not applicable for this study	Usability, aesthetic result, and adequacy of material properties

Indications for Use

The SimPlant Immediate Smile System is intended for use in treatment planning and placement of dental implants, in order to restore masticatory function.

Device Story

System uses CT or MRI imaging data to facilitate pre-operative dental implant planning. Clinician uses SimPlant software to perform image segmentation and 3D anatomical assessment; plans implant positions and orientations in a virtual environment. Output includes patient-specific SurgiGuide surgical templates and prefabricated provisional Immediate Smile bridges. SurgiGuide guides are used intra-operatively to assist in drill site preparation and implant placement. Prefabricated bridges are attached immediately post-implant installation for temporary restoration (up to 12 weeks). System enables predictable restoration by transferring virtual planning to physical tools. Used by clinicians in dental settings to improve implant placement accuracy and restore patient masticatory function.

Clinical Evidence

Clinical evaluation involved 11 doctors and 20 patients across multiple countries. Six implant brands were used. Follow-up conducted at 12 weeks. Metrics included usability, aesthetic results, and material adequacy. Predefined acceptance thresholds for safety and effectiveness were met. Bench testing included software validation, mechanical load testing (400 N point load), and pull-out testing of abutments (avg 232 N, min 190 N).

Technological Characteristics

Software-based image processing system. Materials: PMMA (provisional bridges), biocompatible resins/acrylics (guides), stainless steel (sleeves). Connectivity: DICOM-compliant. Software: C++ based, Windows OS. Sterilization: Not specified (patient-specific components). Standards: ISO 14971, ISO 13485, ISO 10993, DICOM NEMA PS 3.1-3.18.

Indications for Use

Indicated for treatment planning and placement of dental implants to restore masticatory function in partially or fully edentulous patients.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

SimPlant® 2011 (K110300)
Nobel Biocare Guided Surgery Concept (K050393)
Ivoclar Vivadent - Telio CAD (K093708)

Submission Summary (Full Text)

{0}------------------------------------------------ 510(k) Premarket Notification -SimPlant® Immedia ## 510(k) Summary MAY 3 0 2012 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 892.2050. | Submitter: | Materialise Dental NV Technologielaan 15 Leuven Belgium | |-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Establishment Reg. Number: | 3006638827 | | Contact: | Carl Van Lierde QARA Management Representative Materialise Dental NV Technologielaan 15 Leuven Belgium Tel. +32 16 39 6620 Fax. +32 16 39 66 22 Email: Carl.VanLierde@materialise.be | | Date Prepared: | November 29, 2011 | | Trade/ Proprietary Name: | SimPlant Immediate Smile System | | Common/Usual Name: | System, Image processing. The product uses images acquired from Computerized Tomography (CT) scanners | | Classification Name/ FDA Reviewing Branch: | Picture Archiving and Communication system | | Device Classification/ Code: | Class II - 21 CFR §892.2050 LLZ | | Predicate Device Manufacturer: | SimPlant® 2011; (K110300) Nobel Biocare Guided Surgery Concept; (K050393) Ivoclar Vivadent - Telio CAD (K093708) | | Purpose of the 510(k) notice: | The reason for this 510k submission is to request clearance for a device that has been referred to herein as SimPlant Immediate Smile System (Image processing system) referenced under 21 CFR §892.2050 and considered a Class II device. | | Device Description: | The SimPlant Immediate Smile System is intended for use in treatment planning and placement of dental implants, in order to restore masticatory function. The SimPlant Immediate Smile System enables a predictable dental implant restoration procedure according to case planning done by the clinician. The SimPlant Immediate Smile System enables a provisional prosthesis to be produced prior to and attached in the same session as implant installation. The SimPlant Immediate Smile System includes SimPlant software that provides a method of importing medical imaging information from radiological imaging systems such as a Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) to a computer file that is usable in conjunction with other diagnostic tools and expert clinical judgment. Visual representations of the imaged anatomical structures (e.g. the jaw) are derived, allowing for a three-dimensional assessment of the patient without patient contact. SimPlant enables the clinician to plan the dental implant positions including orientations pre-operatively in a virtual, 3D environment. The case planning can be used to produce patient specific SurgiGuide guides, thus transferring the virtual case planning into physical tools enabling the intra-operative preparation of the implant sites for the installation of implants in accordance to the virtual case planning. The SimPlant Immediate Smile System is based upon knowledge of the locations and orientations of the implants prior to surgery. This knowledge enables the production of a SurgiGuide surgical guide. Aided by the SurgiGuide surgical guide, the implant sites can be prepared and the dental implants placed in the predetermined locations, enabling the immediate installation of the custom-made prefabricated provisional Immediate Smile bridge. | | Indications for Use: | The SimPlant Immediate Smile System is intended for use in treatment planning and placement of dental implants, in order to restore masticatory function. | | Technological Characteristics : | The predicate devices, SimPlant® 2011, Nobel Biocare Guided Surgery Concept and Ivoclar - Telio CAD have a number of very similar and equivalent design /technological characteristics, which are very similar and equivalent with the SimPlant Immediate Smile System (see Substantial Equivalence comparison table in Section 14). | | Performance. Data: | Software Validation in addition to bench top performance testing was conducted to ensure the compatibility of all system components. | | Clinical Data: | The SimPlant® Immediate Smile System was evaluated in a clinical setting by 11 doctors from different countries. The System was evaluated with 20 patients. 6 different implant brands were used during the evaluation. Case follow-up was done after 12 weeks. Clinical feedback was gathered for all cases relative to the usability, aesthetic result and adequacy of the material properties of the system components. Predefined acceptance thresholds were met for all criteria indicative for the system safety and effectiveness. The immediate smile bridge component of the System can be used as a temporary restoration for immediate loading up to 12 weeks. The results of the clinical validation confirmed safety and effectiveness of the System. | | Non clinical testing | Several Engineering tests and evaluations were undertaken to demonstrate the conformity of the system: The software is thoroughly tested in accordance with documented test plans and in accordance to internal software development and testing procedures. This test plan is derived from the specifications and ensures that all controls and features are functioning properly. The software is validated together with end-users. The subsequent testing to validate the mitigations was documented in software test reports. The minimal dimension of the cylindrical connections of the immediate smile bridge where determined based on the maximal load that should be withstood without risk of fracture of the bridge. In order to evaluation the potential micro-movement of the implants upon loading of the immediate smile bridge component a predictive (mass-spring/ finite element) model was used. Micro-movement is a risk factor for implant failure. With bite load (point load) of 400 N on bridges without distal extension, predicted movements were shown to be acceptable. Evaluation of cement bonding was conducted via pull-out testing of cylindrical abutments fixed by means of the standard composite into a cylindrical hole corresponding in dimensions with the cylinders incorporated in the design of the provisional restoration. With a average maximal tensile force of 232N and a minimal measured tensile force of 190 N, the threshold of 150 N was exceeded. | 16 . {1}------------------------------------------------ K113739 Page 2 of 8 {2}------------------------------------------------ KU3739 , 510(k) Premarket Notification -SimPlant® Immediate Smile System Page 3 of 8 г {3}------------------------------------------------ ### K113439 4 of 8 રવ 510(k) Premarket Notification -SimPlant® Immediate Smile System | Based on the performance data the SimPlant Immediate Smile System was demonstrated to be safe and effective, testing all pre-set criteria on component and System levels. | | | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------| | Performance Standards: | DICOM NEMA PS 3.1-3.18: Digital imaging and communication in medicine: 2009 ISO14971: Applications of risk management to medical devices: 2007 ISO 13485: Medical devices Quality Management System: 2003 ISO10993: Biological evaluations of medical devices: 1992 | | | | Technological Characteristics: | Materialise Dental NV's SimPlant Immediate Smile System included in this submission uses the same fundamental scientific technology as the previously cleared SimPlant® 2011; (K110300). | | | | | Device for premarket notification | K110300 | | | Material | Trade name | SimPlant® Immediate Smile System | SimPlant® 2011 | | | | Software - Magnetic media Hardware - acrylic guides - biocompatible material stainless steel tubes/sleeves - medical grade PMMA provisional bridges - biocompatible | Software - Magnetic media | {4}------------------------------------------------ $$\mathbf{\hat{r}} \mathbf{\hat{r}} \mathbf{\hat{r}} \mathbf{\hat{u}}$$ f ## 510(k) Premarket Notification -SimPlant® Immediate Sm | Design | Software for use in pre-operative planning. The SimPlant Immediate Smile System includes SimPlant ® software, which provides a means for the clinician for image segmentation and advanced pre-operative planning. This enables the clinician to view three-dimensional CT-scan data as well as to plan the case in a virtual three-dimensional environment. This case planning can be used to produce a Surgical Template, thus transferring the virtual case planning into physical tools enabling the surgical installation according to the virtual case planning. The SimPlant Immediate Smile System is based upon knowledge of the location and orientation of the implant(s) prior to the surgery. This knowledge enables the production of a SurgiGuide. Aided by the SurgiGuide, the sites can be prepared and the implants placed in the predetermined locations enabling the immediate attachment of the prefabricated temporary prosthesis, i.e. the Immediate Smile bridge structure or final prosthesis. | Software for use in pre-operative planning. SimPlant ® software provides a means for image segmentation and advanced pre-operative planning. Surgical templates may be fabricated based on the output of the pre-operative planning. | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | Function | The SimPlant® software component is used to incorporate the images from either an MRI or CT scan of the affected joint into the specialized planning software. The SimPlant® software is used by a qualified surgeon to plan, inspect, fine-tune and approve the pre-surgical plan. The software is used pre- operatively. SimPlant® software contains a library of dental implants, and additional instruments for the placement of implants. A SurgiGuide® guide and/or Immediate Smile Provisional bridge structures may be designed and fabricated based on the output of the pre-operative planning. SurgiGuide® guides are patient specific templates that are intended to transfer the pre-operatively determined positioning of the dental implants to the patient intra-operatively, assisting the surgeon in placing dental implants by guiding and marking drill locations. The Immediate Smile bridge structure is a patient specific temporary restoration, for partially or fully edentulous cases either in lower or upper jaw, to be used immediately after implant placement and this for a short term, i.e. maximally 16 weeks. | SimPlant® software is used to incorporate the images from either an MRI or CT scan of the affected joint into the specialized planning software. The SimPlant® software is used by a qualified surgeon to plan, inspect, fine-tune and approve the pre-surgical plan. The software is used pre-operatively. SimPlant® software contains a library of dental implants, and additional instruments for the placement of implants. A SurgiGuide® guide may be designed and fabricated based on the output of the pre-operative planning. | | Programming language | C++ | C++ | | Operating system | Windows | Windows | . . . . . . . . . . 20 · ・ . . 20 20 : {5}------------------------------------------------ ## 510(k) Premarket Notification -SimPlant® Immediate Smile System {6}------------------------------------------------ K113739 Page 7 of 8 510(k) Premarket Notification --SimPlant* Immediate Smile System | | | Device for premarket notification | K093708 | |-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | SimPlant® Immediate Smile Bridge resin | Ivoclar - Telio CAD | | | Trade name | | | | | Material Chemical Characteri- sitics | 100 % PMMA (Polymethylmethacrylat) | 99.5 % Polymethylmethacrylate (CAS-No. 9011-14-7), Pigments | | | Mechanical Characterisitics | Flexural strength 97 MPaHardness 145 MPa Water absorption 1,1 µg/mm³ | Flexural strength 130 MPa Hardness 180 MPa Water absorption < 28 µg/mm³ Solubility in water < 0.6 µg/mm³ | | | Biocompatibility | Biocompatibility of the dental prosthesis material were performed according to the international standards ISO 10.993-1992 "Biological evaluation of medical devices" (ISO 10993-1, ISO 10993-5, ISO-DIS 10993-10) and DIN-V 13 930-1990 "Biological test of dental materials". The resin did not have any cell toxic potential The resin did not cause any irritation of the skin or any allergic sensitisation. | Test specimens made of Telio CAD were subjected to cytotoxicity and mutagenicity tests. The results of both tests show that Telio CAD is neither cytotoxic nor mutagenic and that its use does not pose a toxicological risk if used as indicated in the respective instructions for use. | | | Storage | To be stored in the original packaging, in a dry environment (< 25 °C), away from direct sunlight. Shelf life 4 years. | No specific requirements. Store at 2-28 °C / 36-82 °F | | | Wear period | Up to 6 months. (i.e. longer than recommended life of the SimPlant Immediate Smile bridge) | 12 months | | Conclusion: | SimPlant Immediate Smile System and its predicate devices, SimPlant® 2011 (K110300), the Nobel Biocare Guided Surgery Concept (K050393) and Ivoclar Telio CAD, have the same technological characteristics and principles of operation. The SimPlant Immediate Smile System can be used with SurgiGuide® guides and / or with provisional Immediate Smile bridges. SurgiGuide® guides are patient specific templates used intra-operatively to prepare the osteotomy for placement of dental implants, manufactured as pre-operatively determined in the software. SurgiGuide guides for upper and/or lower jaw are designed and manufactured using rapid prototyping (stereolithography), based on the approved | | | 22 : {7}------------------------------------------------ Page 8 of 8 510(k) Premarket Notification -SimPlant® Immediate Smile System · | | structures, used immediately after implant placement and manufactured in accordance to the pre-operatively determined implant plan in the software. | |--|-----------------------------------------------------------------------------------------------------------------------------------------------------| | | The differences noted above do not present new issues of safety or effectiveness for the SimPlant® Immediate Smile System. | 23 ・ {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus. The symbol is composed of three curved lines that converge at the bottom. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002 Mr. Carl Van Lierde QARA Management Representative Materialise Dental NV Technologielaan 15 B-3001 LEUVEN BELGIUM MAY 3 0 2012 Re: K113739 Trade/Device Name: SimPlant® Immediate Smile System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, DZE, and EBG Dated: May 25, 2012 Received: May 29, 2012 Dear Mr. Lierde: 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. If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 Parts 801 and 809); medical device reporting (reporting of {9}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as bet form in the up your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of 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/cdrh/industry/support/index.html. Sincerely Yours, Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ 510(k) Premarket Notification -SimPlant® Immediate Smile System # Indications for Use .510(k) Number (if known): K113739 Device Name: SimPlant® Immediate Smile System Indications for Use: The SimPlant Immediate Smile System is intended for use in treatment planning and placement of dental implants, in order to restore masticatory function. Prescription Use _ elok (Part 21 CFR 801 Subpart D) AND/OR (Part 21 CFR 801 Subpart C) 14 Over-The-Counter Use _ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM

Device Facts

Real-World Evidence

Clinical Evidence

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

Panel 1

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SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM

Device Facts

Real-World Evidence

Clinical Evidence

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

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