SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE

{0}------------------------------------------------ # Section 006 - 510(k) Summary (SMDA Requirements) Additional Information - March 31, 2014 # APR 1 1 2014 This Summary of Safety And Effectiveness is submitted in accordance with 21 CFR 807.92.c. # 01 - Administrative Information #### Date Prepared: 01- a. 510(k) Submitter 01-b. June 20, 2013 SATELEC 17, Avenue Gustave Eiffel BP 30216 33708 Merignac Cedex France 011-33-556-340-607 Telephone: 011-33-556-349-292 Fax: E-Mail: philippe.girard@acteongroup.com #### 01-c. Contact Person: Rick Rosati SATELEC clo ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 800-289-6367 Ext: 390 Telephone: 856-222-4726 Fax: E-Mail: rick.rosati@us.acteongroup.com 01- e. Establishment registration number # 02 - Device Information Trade Name of Device: 02-a. Common Name of Device: 02-b. Classification Requiation: 02-c. Medical Device Class: 02-d. 02-e. Panel: 02-f. Product Code: 8044015 SCANWAVE PEN Ultraviolet Activator for Polymerization 21 CFR 872.6070 ll Dental EBZ Pre-Market Notification 510(k) Submission for SCANWAVE PEN By SATELEC Market Notification of of(k) - Confidential Document - Version 02 Image /page/0/Picture/27 description: The image shows the text "006 - 1". The numbers are written in a simple, sans-serif font. The text is black and the background is white. The text is centered in the image. Image /page/0/Picture/28 description: The image shows the logo for Satelec Acteon. The word "SATELEC" is in smaller font above the word "ACTEON", which is in a larger, bold font. There is a curved graphic to the left of the word "ACTEON". Image /page/0/Picture/29 description: The image shows a logo with the letter 'G' at the top. Below the 'G', there is some smaller text that is difficult to read. At the bottom of the logo, the text 'ISO 13485' is visible. The logo appears to be a certification mark related to ISO 13485 standards. SATELEC . A company of ACTEON Group Gustave Eiffel • BP 30216 • 33708 MERIGNAC cedex • FRANCE • Gustave E-mail: satelec@acteongroup.com . www.acteongroup.com Société pour la Conception des Techniques Electroniques Electroniques , S.A. 5. au captal de 1 309 548 E R.C. Bordeaux 8 782 016 240 × Nº intracommunautaire FR 39.782 016 240 {1}------------------------------------------------ # Section 006 - 510(k) Summary (SMDA Requirements) Additional Information - March 31, 2014 # 03 - Identification of Legally Marketed Predicate Device(s) The Substantial Equivalence (SE) of SCANWAVE PEN is based on the Predicate Devices identified in the Table 01. ### Table 01 - Identification of Legally Marketed Predicate Devices | Trade Name | Manufacturer | Product<br>Code | 510(k)<br>number | Date Cleared | |--------------------|-----------------------------------|-----------------|------------------|--------------------| | MINI LED AUTOFOCUS | SATELEC | EBZ | K072181 | September 19, 2007 | | BLUEPHASE® 20i | IVOCLAR VIVADENT,<br>Incorporated | EBZ | K091020 | June 12, 2009 | # 04 - Intended Use of SCANWAVE PEN SCANWAVE PEN is a source of illumination for the polymerization of light-curing dental materials curing in the wavelength range of 390 nm - 505 nm. # 05 - Description of SCANWAVE PEN #### Scientific principles 05-a. The specific wavelengths of the light source activate the photo-initiators contained in the dental The specific wavelengths of the photo-initiators produces the hardening of the dental material. #### Principles of operation 05-b. SCANWAVE PEN is a Dental Curing Light. More precisely, SCANWAVE PEN is a source of illumination used for the polymentation of light-curing dental materials curing in the wavelength lillumination used for the polymenzation of ight Guiller Children Cambridge of Shitting Diode) which permit to polymerize a large range of dental materials present on the market. # 06 - Description of SCANWAVE PEN Design SCANWAVE PEN is an Electro-medical Device. SCANWAVE PEN is compatible with only ADEC SCANVVAVE PEN Is an Liectromic command board, the power board, the power board and the Dental units. The nanuplece contains the olyonsmit the light delivered by the Handpiece on the light source. The rigid protection shield to the Handpiece reduces the light propage the light course during the ciritial site: The nglo protection shills hise of the patient and the user during the connig Light. This accessory is used to p p ower supply module intended to deliver the electical polymenzation ac. The O.L.M Module is a power buppy the Module is integrated in an ADEC source needed for the Tranqplece Tunctioning of The Call needed information for a correct using (description, safety aspects, problems, cleaning, disinfecting and sterilization procedures). # 07 - Identification of the Risk Analysis Method The risks to health associated to SCANWANVE PEN are managed through the section of 7 of the section of 7 of the The nexs to Treatin associated to SOAWW N it = Premarket Notification [510(k)] Submission = Guidance Document hamed 'Dental Outling Eights' - Fredance Document are covered by Several March 27, 2006. The Identified risks of the applicable Guidance Document billy, too March 21, 2000: The loomined hold on the signification and biocompatibility tests, labeling, performance tests). Pre-Market Notification 510(k) Submission for SCANWAVE PEN By SATELEC K131906 - Abbreviated 510(k) - Confidential Document - Version 02 Image /page/1/Picture/18 description: The image shows a logo with the letter 'G' prominently displayed at the top. Below the 'G', there is some smaller text that appears to be 'ISO 13485'. The logo has a textured or slightly distressed appearance, giving it a somewhat vintage or stylized look. The overall impression is that of a certification mark or a company logo related to quality standards. SATELEC . A company of ACTEON Group Eiffel « BP 30216 • 33708 MERIGNAC cedex » FRANCE Gustave 33 (0) 556 34 06 07 * Fax + 33 (0) 556 34 92 92 E-mail: satelec@acteongroup.com · www.acteongroup.com Société pour la Conception des Techniques Electroniques • S.A.S. au capital de 1 309 548 € R.C. Bordeaux 8 782 016 240 . N. Intractimmunautaire FR 39 782 016 240 Image /page/1/Picture/20 description: The image shows the logo for Satelec Acteon. The word "ACTEON" is in large, bold, sans-serif font, with a curved line extending from the left side of the "A" and going under the word. Above and to the right of "ACTEON" is the word "SATELEC" in a smaller, sans-serif font. The logo appears to be in black and white. {2}------------------------------------------------ # Section 006 ~ 510(k) Summary (SMDA Requirements) Additional Information - March 31, 2014 Additional Information – March 31, 2014 # 08 - Description of the performance aspects The Depth of Cure performed on Dental Materials (resins) is identified as the intended performances of SCANWAVE PEN. Comparison tests of Depth of Cure have been performed performances of OO/NVW (ve ) Eedicate Devices. The obtained results show that the Depths of between SCANWAVE PEN are substantially equivalent and coherent with the claimed Intended Use. # 09 - Intended Use of SCANWAVE PEN compared to the Predicate Device ### Table 02 - Indication for Use Comparison | Trade / Device<br>name | SCANWAVE PEN | Predicate<br>Device n°1 | Predicate<br>Device n°2 | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------| | Intended Use | SCANWAVE PEN is a<br>source of illumination<br>for the polymerization<br>of light-curing dental<br>materials curing in the<br>wavelength range of<br>390 nm - 505 nm. | The Satelec Mini LED<br>AutoFocus is intended to<br>be used by qualified<br>dental practitioners as an<br>ultraviolet activator for<br>polymerization for:<br>Photo-polymerization in<br>the 420 - 480 nm<br>waveband of visible light<br>cured (VLC) dental<br>materials.<br>Photo polymerization in<br>the 420 - 480 nm<br>waveband of visible light<br>cured (VLC) restorative<br>composite materials, and<br>Photo-polymerization in<br>the 420 - 480 nm<br>waveband of visible light<br>cured (VLC) orthodontic<br>brackets, and orthodontic<br>bonding and sealing<br>materials | For the<br>polymerization of<br>light-curing dental<br>materials curing in<br>the wavelength<br>range of 380-515<br>nm. | | Part | 872 - Dental devices | | | | Regulation<br>Number | 21 CFR 872.6070 | | | | Regulation<br>Name | Ultraviolet Activator for Polymerization | | | | Regulatory<br>Class | 11 | | | | Product Code | FBZ | | | Pre-Market Notification 510(K) Submission for SCANWAVE PEN By SATELEC Market Notification of o(k) - Confidential Document - Version 02 006 - 3 Image /page/2/Picture/9 description: The image shows the logo for ACTEON SATELEC. The word "ACTEON" is written in large, bold, black letters. Above the right side of the word "ACTEON" is the word "SATELEC" in smaller, black letters. There is a curved line that starts below the left side of the word "ACTEON" and curves up and over the word. G ISO 13485 SATELEC . A company of ACTEON Group 17 av. Gustave Eiffel . BP 30216 . 33708 MERIGNAC cedex . FRANCE Tel + 33 (0) 556 34 06 07 · Fax + 33 (0) 556 34 92 92 E mail: satelec@acteongroup.com · www.acteongroup.com Societé pour la Conception des Applications des Techniques Electroniques • S.A.S. au capital de 1 309 548 € R.C. Bordeaux B 782 016 240 · N' intracommunautaire FR 39 782 016 240 {3}------------------------------------------------ # Section 006 - 510(k) Summary (SMDA Requirements) Additional Information - March 31, 2014 # 10 – Technological characteristics of SCANWAVE PEN compared to the Predicate Devices Table 03 – Technological characteristics and performances Comparison | | | Predicate Device n°1 | Predicate Device n°2 | |------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------| | | SCANWAVE PEN | MINILED<br>AUTOFOCUS | BLUEPHASE® 20i | | Handpiece Dimensions | | | | | Overall Weight (g) | 76 | 99 | 143 | | Overall Size (mm) | | Ø 24 x 122 | 46 x 197 | | Light Sources | | | | | Quantity / Source | | 4 LED | 4 LED | | Range of<br>Wavelength (nm) | | 390 to 505 | 385 to 515 | | Power Source | | | | | Type | | O.E.M. Module | Main adapter | | Input Voltage (VAC) | | 24 | 100-240 | | Output Voltage (DC) | | | | | | | 5 | | | Handpiece Input Voltage | | | | | Input Voltage (VDC) | | 5 V | 3.7 - 5V | | Safety Controls | | | | | Safety Controls | Activation of a thermal sensor in case of overheating in the device<br>(caused by an intensive using) | | | | Material | | | | | Handpiece | | Metallic Body (aluminum) | Plastic Body | | Optical Guide | | Glass and metallic part | Glass and<br>plastic part | | Optical Protector | | Plastic | | | Performance Specifications | | | | | Typical Irradiance<br>at 2 mm (mW/cm²) | | 1500 | 2000 - 2200 | | Depth of Cure (mm)<br>depending of dental<br>Materials and<br>Polymerization modes | | 0.5 to 4.5 | 0.5 to 4 | | Standards | | | | | Safety & EMC<br>Standard | IEC60601-1 / IEC60601-1-2 | | | | Specific Standard<br>for Dental Curing<br>Light | | ANSI / ADA Standard No. 48 - Visible Light<br>Curing Unit - Part 2 - Light Emitting Diode<br>(LED) | ANSI / ADA<br>Specification No. 48,<br>Visible Light Curing | | Fire aspects | | UL94-V0 for Printed Circuit Boards | Unknown | Pre-Market Notification 510(k) Submission for SCANWAVE PEN By SATELEC Market Nothication 070(k) - Confidential Document - Version 02 006 - 4 Image /page/3/Picture/6 description: The image shows the logo for Satelec Acteon. The word "ACTEON" is written in large, bold, black letters. Above and to the right of "ACTEON" is the word "SATELEC" in smaller letters. A curved line is to the left of the word "ACTEON". Image /page/3/Picture/7 description: The image shows a logo with the letter 'G' in a stylized font. Below the letter 'G', the text 'REGISTERED' is written in a smaller font. Underneath the word 'REGISTERED', the text 'ISO 13485' is written. The logo appears to be a certification mark related to ISO 13485 standards. SATELEC » A company of ACTEON Group 17 av. Gustave Elffel · BP 30216 · 33708 MERIGNAC cedex · FRANCE 17 - 11 - 13 - 10 - 13 - 10 - 13 - 15 - 12 - 12 - 12 - 12 - 12 - 12 - 12 - 14 - 13 - 14 - 13 - 14 - 13 - 14 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - {4}------------------------------------------------ # Section 006 - 510(k) Summary (SMDA Requirements) Additional Information - March 31, 2014 ### 11 - Determination of substantial equivalence SCANWAVE PEN and Predicate Devices are identified as Ultraviolet Activators for Polymerization according to Classification Regulation n°21 CFR 872.6070 used for Dental Applications. #### Indication for Use Perspective 11-a. SCANWAVE PEN Indications for Use are Substantially Equivalent to the Predicate Devices. #### Design Perspective 11-b. In Design Perspective: - SCANWAVE PEN and the Predicate Device n°1 are Substantially Equivalent in term of ● dimensions. - SCANWAVE PEN and Predicate Devices are Substantially Equivalent in term of Light � sources (LED light source). - The SCANWAVE PEN and the Predicate Device n°1 are Substantially Equivalent in term ● of Operation Modes and Command. - The SCANWAVE PEN and Predicate Devices are Substantially Equivalent in term of . Power Source. - The SCANWAVE PEN and Predicate Device n°1 are Substantially Equivalent in term of Design. #### Material Perspective 11-c. In Material Perspective, the Substantial Equivalence document has defined that: - The Material of SCANWAVE PEN and Predicate Device n°1 are identical. . - The Material potentially in direct contact with the patient of SCANWAVE PEN and . Predicate Device nº1 are identical. #### Discussion and conclusion of the non-clinical Tests 11-d. ### Polymerization performance: The aim of the non clinical tests (on test bench) was to demonstrate the Substantial Equivalence The allif of the non official (one selected Predicate Devices in terms of Polymerization of the SCANNVAVE TEN and the belowed values of Depth of Cure shows that the depths of Penomance. The Companson of the Obtailion valuation of the Predicate Devices. In conclusion, Our of SCANNAVE FEN are Gubliantali, CANWAVE PEN and the Predicate Devices are Substantially Equivalent in performance of polymerization point of view. ### Specific standard for Dental Curing Lights: Specific Standard for Boman tested according to a specific standard (Specification No 48) Also, SOANWAVE I EN has boom toologies to the results demonstrate that SCANWAVE PEN is compliant to the applicable standard for Dental Curing Lights. Discussion and conclusion of the clinical Tests 11-e. Clinical tests are not required to establish the Substantial Equivalence. # 12 - Conclusion SCANWAVE PEN is Substantially Equivalent to the Predicate Devices (K072181, cleared September 19, 2007 and K091020, cleared June 12, 2009). # End of Section Pre-Market Notification 510(K) Submission for SCANWAVE PEN By SATELEC K131906 - Abbreviated 510(k) - Confidential Document - Version 02 006 - 5 Image /page/4/Picture/28 description: The image shows the logo for Satelec Acteon. The word "ACTEON" is written in large, bold, black letters. Above the word "ACTEON" is the word "SATELEC" in smaller letters. To the left of the word "ACTEON" is a black curved line. Image /page/4/Picture/29 description: The image shows a logo with the letter 'G' in a stylized font. Below the letter, there is some text that appears to be a registration or identification number, specifically 'CO.13485'. The logo is in black and white and has a slightly distressed or textured appearance. SATELEC . A company of ACTEON Group Eiffel · BP 30216 · 33708 MERIGNAC cedex · FRANCE et + 33 103 556 34 06 07 + Fax + 33 101 556 34 92 92 E-mail: sarelec@acteoneroup.com · www.acteongroup.com Société pour la Conception des Applications des Techniques · S.A.S. au cap!tal de 1 309 548 € R.C. Bordeaux B 782 016 240 · N' intracommunautaire FR 39 782 016 240 {5}------------------------------------------------ Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved shapes that resemble a human figure embracing or supporting something, representing health and human services. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 # April 11, 2014 Satelec-Acteon Group Rick Rosati Quality Manager 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Re: K131906 Trade/Device Name: Scanwave pen (with light gray cord), Scanwave pen (with medium gray cord), Scanwave pen (with dark gray cord) Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: Class II Product Code: EBZ Dated: March 10, 2014 Received: March 11, 2014 Dear Mr. Rosati: 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. 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 {6}------------------------------------------------ Page 2 - Mr. Rick Rosati 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/ResourcesforYou/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Mary S. Runner -S Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ### Section 005 - Indication for Use Indications for Use # 510(k) Number (if known): K131906 Device Name: SCANWAVE PEN Indications for Use: SCANWAVE PEN is a source of illumination for the polymerization of light-curing dental materials curing in the wavelength range of 390 nm - 505 nm. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) # Sheena A. Green -S 2014.04.12 20:24:34 -04'00' Page 1 of 1