(53 days)
Not Found
No
The summary describes a resin-based impression material and its comparison to a predicate device based on physical properties and performance characteristics relevant to dental impressions, with no mention of AI or ML.
No.
The device is used to reproduce the structure of teeth and gums, which is a diagnostic/measurement function, not a therapeutic one. It does not treat or cure any condition.
No
The device is used to reproduce the structure of teeth and gums (impressions), not to identify or diagnose a disease or condition.
No
The device description explicitly states that Blugoo HD is a three-part product consisting of two-part resin-based impression mixes (Part A, Part B, and Part C), which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reproduce the structure of a patient's teeth and gums." This is a physical reproduction for dental procedures, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The device is an impression material used to create a mold of the teeth and gums. This is a physical process, not a diagnostic assay.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
The device is a dental impression material, which falls under the category of medical devices used for physical procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Blugoo HD is used to reproduce the structure of a patient's teeth and gums.
Product codes
ELW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's teeth and gums
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3660 Impression material.
(a)
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.(b)
Classification. Class II (Special Controls).
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.
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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
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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
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REGULATORY SPECIALISTS, INC.