← Product Code [ELW](/productcode/ELW) · K071192 # BLUGOO HD (K071192) _Lancer Orthodontics, Inc. · ELW · Jun 22, 2007 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K071192 ## Device Facts - **Applicant:** Lancer Orthodontics, Inc. - **Product Code:** [ELW](/productcode/ELW.md) - **Decision Date:** Jun 22, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3660 - **Device Class:** Class 2 - **Review Panel:** Dental ## Indications for Use Blugoo HD is used to reproduce the structure of a patient's teeth and gums. ## Device Story Blugoo HD is a dental impression material consisting of a three-part resin-based system (Parts A, B, and C). Parts A and B function as a two-part impression mix, while Part C (Yellow Wash) is a two-part resin-based material used in conjunction with the primary mix to achieve high-definition impressions. The device is used by dental professionals to capture the anatomical structure of a patient's teeth and gums. The resulting impression is used to create accurate dental models for clinical decision-making and restorative procedures. ## Clinical Evidence No clinical data. Substantial equivalence is based on bench testing comparing physical and performance characteristics (e.g., dimensional change, elastic recovery, detail reproduction) to the predicate device. ## Technological Characteristics Resin-based dental impression material. Three-part system (A, B, and C). Characteristics include specific mixing time, working time, minimum removal time, linear dimensional change, elastic recovery, strain in compression, and detail reproduction capabilities. Compatible with gypsum models. ## Regulatory Identification Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures. ## Special Controls *Classification.* Class II (Special Controls). ## Predicate Devices - Extrude ([K012405](/device/K012405.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Premarket Notifications [510(k)], Blugoo, Lancer Orthodontics JUN 2 2 2007 Image /page/0/Picture/1 description: The image contains the text "5. 510(k) Summary" on the left side of the image. To the right of the text is the number K071192. Below the number is the logo for Lancer Orthodontics. Submitter's name: Address: Phone: Fax number: Name of contact person: Lancer Orthodontics 253 Pawnee Street San Marcos, CA 92078 760-744-5585 760-744-5842 Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 fax: 949-552-2821 | Date the summary was prepared: | April 25, 2007 | |--------------------------------|----------------------------| | Name of the device: | Blugoo HD | | Trade or proprietary name: | Blugoo HD | | Common or usual name: | Dental impression material | | Classification name: | Material, Impression | The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: Extrude, manufactured by Sybron Dental Specialties, Inc. The reference number is K012405. Description of the device: Blugoo HD is a three part product (Part A, Part B, and Part C). Part A and B are a two part resin based impression mix. Blugoo HD Part C Yellow Wash is a two part resin based impression material. It can be used in conjunction with Blugoo HD for high definition impressions. Indications: Blugoo HD is used to reproduce the structure of a patient's teeth and gums. {1}------------------------------------------------ Summary of the technological characteristics of our device compared to the predicate device: Extrude, manufactured by Sybron Dental Specialties, Inc. and Blugoo HD were compared in the following areas and found to have similar technological characteristics and therefore to be equivalent. Anatomical sites Design Formulation Type Intended use Mixing time Working time Min removal time from start of mix Linear dimensional change Elastic recovery Strain in compression Impression longevity Storage conditions Detail reproduction Compatibility with gypsum {2}------------------------------------------------ Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other, with 'Public' on the top line, 'Health' on the second line, and 'Service' on the bottom line. Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white. JUN 2 2 2007 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Lancer Orthodontics, Incorporated C/O Ms. Grace Holland Regulatory Specialists. Incorporated 3722 Ave. Sausalito Irvine, California 92606 Re: K071192 Trade/Device Name: Blugoo HD Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: June 14, 2007 Received: June 18, 2007 Dear Ms. Holland: 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 either class II (Special Controls) or class III (PMA), it may be subject to such 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. {3}------------------------------------------------ Page 2 - Ms. Grace Holland 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing 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 Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## 4. Indications for Use Statement Indications for Use 510(k) Number (if known): k671192 Device Name: Blugoo HD Indications For Use: Blugoo HD is used to reproduce the structure of a patient's teeth and gums. Prescription Use AND/OR Over-The-Counter Use > (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ## Concurrence of CDRH, Office of Device Evaluation (ODE) Suren Punne Ton Sign-Off) sion of Anesthesiology, General Hospital, Jonon Control, Dental Devices K Number: K071193 Page 1 of 1 REGULATORY SPECIALISTS, INC. --- **Source:** [https://fda.innolitics.com/device/K071192](https://fda.innolitics.com/device/K071192) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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