(24 days)
Not Found
No
The device description and intended use clearly describe a dental impression material, which is a physical substance, not a software or system that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is a dental impression material used to create molds of teeth and oral structures, not to treat or cure any medical condition.
No
Explanation: The "Intended Use / Indications for Use" section clearly states that StatusBlue is "indicated for use as a dental impression material" for various types of impressions. This material is used to create a physical mold of a patient's teeth and gums, which is a manufacturing step, not a diagnostic one. Diagnostic devices typically identify diseases, conditions, or provide information for diagnosis, which is not the purpose of an impression material.
No
The device description explicitly states it is a "dimensionally stable polyvinyl siloxane material" supplied in "MixStar cartridges," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that StatusBlue is a dental impression material used for creating impressions of teeth and oral structures. This is a physical process for creating a mold, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The description reinforces that it's a material for taking impressions, a physical process.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health condition.
- Predicate Device: The predicate device (3M/ESPE Dimension Penta impression material) is also a dental impression material, further indicating its non-IVD nature.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
StatusBlue is indicated for use as a dental impression material in the following applications:
- Situation impressions of any kind;
- Impressions for the preparation of provisionals;
- Impressions for orthodontic models;
- Impressions of the opposing jaw;
- Impressions for the manufacture of model cast dentures
Product codes
ELW
Device Description
The StatusBlue dental impression material is a dimensionally stable polyvinyl siloxane material designed as an alternative to alginate impression materials. It will be supplied in prefilled, ready-to-use MixStar cartridges. StatusBlue is intended for use in commercially available impression trays.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence for this device was based solely on design and technical specifications; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the StatusBlue material are equivalent to those of the predicate devices. The proposed StatusBlue material complies with ISO 4823 (Dental Elastomeric Impression Materials).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
OCT 2 2 2001
September 17, 2001 Status Blue
KO1323
510(k) Summary
Trade Name: StatusBlue
Sponsor: DMG USA, Inc.
414 South State Street
Dover, DE 19901
Registration # not yet assigned
Owner/Operator No. 9005969
Device Generic
Name: Dental impression material
Classification: According to Section 513 of the Federal Food, Drug, and
Cosmetic Act, the device classification is Class II.
Predicate Device:
The proposed DMG USA StatusBlue material is substantially equivalent to other currently marketed dental impression materials including the 3M/ESPE Dimension Penta impression material (K974231).
Product Description:
The StatusBlue dental impression material is a dimensionally stable polyvinyl siloxane material designed as an alternative to alginate impression materials. It will be supplied in prefilled, ready-to-use MixStar cartridges. StatusBlue is intended for use in commercially available impression trays.
Indications for Use:
StatusBlue is indicated for use as a dental impression material.
Safety and Performance:
Substantial equivalence for this device was based solely on design and technical specifications; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the StatusBlue material are equivalent to those of the predicate devices. The proposed StatusBlue material complies with ISO 4823 (Dental Elastomeric Impression Materials).
Conclusion:
Based on the indications for use, technological characteristics, and comparison to the predicate device, the StatusBlue material has been shown to be safe and effective for its intended use.
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DMG USA. Incorporated C/O Ms. Pamela Papineau Consultant Delphi Medical Device Consulting 5 Whitcomb Avenue Ayer, Massachusetts 01432
Re: K013237
Trade/Device Name: StatusBlue Regulation Number: 872.3660 Regulation Name: Dental Impression Material Regulatory Class: II Product Code: ELW Dated: September 17, 2001 Received: September 28, 2001
Dear Ms. Papineau:
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.
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
OCT 22 2001
2
Page 2 - Ms. Papineau
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 (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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy J. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
3
September 17, 2001 StatusBlue
1 Page -1613237
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: StatusBlue
Indications for Use:
StatusBlue is indicated for use as a dental impression material in the following applications:
- · Situation impressions of any kind;
- · Impressions for the preparation of provisionals;
- · Impressions for orthodontic models;
- · Impressions of the opposing jaw;
- · Impressions for the manufacture of model cast dentures
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the -Counter Use
Susan Rinner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi 510(k) Number _
000008