(11 days)
Not Found
No
The device description focuses on the physical properties and application methods of polyether impression materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
This device is an impression material used for taking dental impressions, which is a diagnostic or procedural tool, not a therapeutic intervention for treating a disease or condition.
No
Explanation: The device is an impression material used to create molds of dental structures, which is a part of the treatment process rather than diagnosis. Its intended use is for "Impressions of inlay, onlay, veneer, crown, and bridge preparations" and "Fixation and implant impressions".
No
The device description clearly states that the devices are polyether impression materials, which are physical substances used to take impressions. This indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to take impressions of dental preparations and for fixation and implant impressions. This is a physical process of creating a mold of anatomical structures.
- Device Description: The device is a polyether impression material. These materials are used to physically capture the shape of teeth and gums.
- Lack of Diagnostic Purpose: The description does not mention any diagnostic purpose. The material itself is not used to analyze a sample from the body to provide information about a disease or condition. It's a tool for creating a physical model.
- Anatomical Site: While it interacts with the patient's teeth and gums, this interaction is for the purpose of creating an impression, not for analyzing a biological sample.
IVD devices are typically 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
· Impressions of inlay, onlay, veneer, crown, and bridge preparations
· Fixation and implant impressions
RAPID HB, MB and LB are especially suitable for taking impressions of single-unit and double-unit preparations.
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
Rapid HB, Rapid LB and Rapid MB are a group of polyether impression materials of heavy, light and medium consistency used by dental professionals individually or in combination. Rapid HB and Rapid MB are mixed in the Pentamix mixing device, while Rapid LB can be applied directly using the Garant dispenser.
Rapid HB is a heavy bodied hydrophilic impression material used in one step technique. Thereby Rapid HB is used in combination with the light consistency wash material Rapid LB. Rapid HB is reddish-violet colored.
Rapid LB is a light bodied hydrophilic impression material used in one step technique. Thereby Rapid LB is used in combination with the higher consistency tray material Rapid LB is apple green colored.
Rapid MB is a medium bodied hydrophilic impression material used in mono-phase technique (Rapid MB as syringing and as tray material) and in one step technique (Rapid LB as syringing and Rapid MB as tray material). Rapid MB is blueish-violet colored.
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
dental professionals
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)
Non-clinical testing: In vitro testing was conducted to show that Rapid HB, Rapid LB and Rapid MB fulfils the requirements of FDA recognized standard ISO 4823. Additionally, the performance of Rapid HB, Rapid LB and Rapid MB was compared to the predicate devices Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB regarding consistency, contact angle, working time, intraoral setting time, recovery from deformation, strain in compression, detail reproduction, compatibility with gypsum type 3 / type 4 and linear dimensional change. The results of Rapid LB and Rapid MB fulfill the requirements of ISO 4823 and are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB. In summary, 3M Deutschland GmbH concludes that Rapid HB, Rapid LB and Rapid MB is substantially equivalent to the predicate devices regarding performance and physical and mechanical properties.
Biocompatibility: The biocompatibility assessment for the products was conducted in accordance with the following guidance: US FDA Docket Number FDA-2013-D-0350. CDRH Document Number 1811 (June 16, 2016), Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - Guidance for Industry and Food and Drug Administration Staff; ISO 10993-1 (2009), Evaluation and testing within a risk management process; ISO 10993-5 (2009), Tests for in vitro cytotoxicity; ISO 10993-10 (2010), Tests for irritation and skin sensitization; ISO 10993-11 (2006), Tests for systemic toxicity; ISO 10993-12 (2012), Sample preparation and reference materials; ISO 10993-18 (2005), Chemical characterization of materials; ISO 7405 (2008/Amd 1:2013), Evaluation of biocompatibility of medical devices used in dentistry. The biocompatibility of Rapid LB, Rapid LB and Rapid MB has been assessed by a board-certified toxicologist according to recommendations in FDA guidance and internationally recognized standards for medical and dental devices. The conclusion of the assessment is that Rapid HB, Rapid LB and Rapid MB are safe for their intended use.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
3M Deutschland GmbH % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K173318
Trade/Device Name: Rapid HB, Rapid LB, Rapid MB Regulation Number: 21 CFR 872.3660 Regulation Name: Impression material Regulatory Class: Class II Product Code: ELW Dated: October 18, 2017 Received: October 20, 2017
Dear Mr. Mark Job:
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. Isting 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.
October 31, 2017
1
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); 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 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/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/ResourcesforYou/Industry/default.htm.
Sincerely,
Image /page/1/Picture/8 description: The image shows the name "Mary S. Runner -S" in a large, bold font. The text is black and appears to be against a white background. The letters are clearly legible and well-defined.
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Change Control Table, Change History
Change Control Table
| Version | Document Author | Document Approver | Date Approved |
|---|---|---|---|
| 1.00 | Name, Title, Office | Name, Title, Office | MM/DD/YYYY |
Complete Change Control Table (all versions) retained in SWIFT Docs.
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name Rapid HB Rapid LB Rapid MB
Indications for Use (Describe)
· Impressions of inlay, onlay, veneer, crown, and bridge preparations
· Fixation and implant impressions
RAPID HB, MB and LB are especially suitable for taking impressions of single-unit and double-unit preparations.
| Type of Use (Select one or both, as applicable) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | EF |
|---|---|---|---|
| ---------------------- | ------------- | ---------------------------------------- | ---- |
4
3M Deutschland GmbH
Carl-Schurz-Straße 1 41453 Neuss Germany
Postal Address: ESPE Platz 82229 Seefeld Germany
☎+49 (0)8152 700-0 鳥+49 (0)8152 700-1366 Internet: www.3M.de/OralCare E-Mail: info3MESPE@3M.com WEEE-Reg.-Nr. DE 36963167 VAT-ID: DE 120679179
510(k) Summary K173318
| Submitter: | 3M Deutschland GmbH
ESPE Platz
82229 Seefeld
Germany
Establishment Registration Number: 9611385 |
|----------------|-------------------------------------------------------------------------------------------------------------|
| Contact Person | Ruediger Franke
Regulatory Affairs Specialist
Phone: +49-8152-700 1802
Fax: +49-8152-700 1869 |
| Phone: +49-8152-700 1602 |
|---|
| Fax: +49-8152-700 1869 |
| e-mail: ruediger.franke@3M.com |
| Date: October 4. 2017 |
| Trade Name: | Rapid HB |
|---|---|
| Rapid LB | |
| Rapid MB |
Common Name: ........................................ Polyether impression material
Classification Name:.......................................................................................................................................................... ..............................................................................................................................................................................
Device Class: ................................................................................................................................................................
Predicate Devices ....................... Impregum Penta Soft Quick Step HB (K032001) .............................................................................................................................................................................. ..............................................................................................................................................................................
Description of Device
Rapid HB, Rapid LB and Rapid MB are a group of polyether impression materials of heavy, light and medium consistency used by dental professionals individually or in combination. Rapid HB and Rapid MB are mixed in the Pentamix mixing device, while Rapid LB can be applied directly using the Garant dispenser.
Rapid HB is a heavy bodied hydrophilic impression material used in one step technique. Thereby Rapid HB is used in combination with the light consistency wash material Rapid LB. Rapid HB is reddish-violet colored.
Sitz: 41453 Neuss · Handelsregister: B 1878 Amtsgericht Neuss Geschäftsführer: Prof. Dr. Joerg Dederichs, Christiane Grün, Nicolas Jennepin, Michael Peters Vorsitzende der Geschäftsführung: Christiane Grün; Vorsitzender des Aufsichtsrates: Günter Gressler
5
Rapid LB is a light bodied hydrophilic impression material used in one step technique. Thereby Rapid LB is used in combination with the higher consistency tray material Rapid LB is apple green colored.
Rapid MB is a medium bodied hydrophilic impression material used in mono-phase technique (Rapid MB as syringing and as tray material) and in one step technique (Rapid LB as syringing and Rapid MB as tray material). Rapid MB is blueish-violet colored.
Applicable Standards for Product Tests
- . ISO 4823: Dentistry - Dentistry - Elastomeric Impression Materials
Indications for Use for Rapid HB, Rapid LB and Rapid MB
- · Impressions of inlay, onlay, veneer, crown, and bridge preparations
- Fixation and implant impressions
RAPID HB, MB and LB are especially suitable for taking impressions of single-unit and doubleunit preparations.
Comparison
Rapid HB, Rapid LB and Rapid MB were compared to Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB regarding indications for use, intended use, composition technology and physical and mechanical properties.
The tables below summarize the indications and technology of Rapid HB, Rapid LB and Rapid MB and predicate devices:
| Indications
Comparison | Rapid HB
Rapid LB
Rapid MB | Predicate Devices (K032001) |
|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use
(from the
Indications for
Use form) | • Impressions of inlay,
onlay, veneer, crown, and
bridge preparations
• Fixation and implant
impressions
RAPID HB, MB and LB are
especially suitable for
taking impressions of
single-unit and double-unit
preparations. | Impregum Penta Soft Quick Step
HB
Poly Q Penta H:
Tray material for dual phase
impression techniques.
Impregum Soft Quick Step LB
Poly Q Garant L:
Wash material for dual phase
impression techniques.
Impregum Penta Soft Quick Step
MB
Poly Q Penta M:
Impression material for monophase
technique. |
| Intended Use | Intended to be placed on a
preformed impression tray
and used to reproduce the
structure of a patient's teeth
and gums | Intended to be placed on a
preformed impression tray and used
to reproduce the structure of a
patient's teeth and gums |
Table Comparison of indications
6
The differences between the indications of the Rapid materials and the predicate devices are not critical to the intended clinical use because the Rapid indications described the clinical case whereas the predicate indication described the usable impression technique of each material. All clinical indications (inlay, onlay, veneer, crown, and bridge preparations as well as fixation and implant impressions) are achievable with the described impression techniques (dual phase and monophase technique). This difference, i.e., stating clinical cases rather than impression techniques, does not raise any new questions regarding safety or effectiveness. Rather, it clarifies the appropriate uses within the described impression techniques and does not expand the indications of the new device(s) beyond those of the predicate device(s).
| Technology | Rapid HB
Rapid LB
Rapid MB | Impregum Penta Soft Quick Step HB
Impregum Penta Soft Quick Step MB
Impregum Soft Quick Step LB
(K032001) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Light bodied material offered in
Garant cartridge system with mixing
ratio of base and catalyst pastes 2:1
(by volume)
The pastes are mixed using Garant
mixing tips or Intra-oral syringe. | × | × |
| Medium and Heavy bodied material
offered in Penta foil bags with mixing
ratio of base and catalyst paste 5:1
(by volume).
The pastes are mixed in automatic
mixing machine of the Pentamix
family and Penta mixing tip. | × | × |
| Material family | Polyether
material | Polyether material |
| Setting characteristic | super quick | quick |
Table Comparison to Predicate Technology
Rapid HB, Rapid LB and Rapid MB, Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Imprequm Soft Quick Step LB are Polyether based Precision Impression materials. Chemically they are based on polyalkyleneoxides which cure by a cationic ringopening polymerization mechanism which is initiated by a Sulfonium starter. However, Rapid materials have been developed with the goal to accelerate the curing mechanism by adjusting the initiator system. Additives like fillers, softeners, pigments etc. have been adjusted accordingly.
7
Non-clinical testing
In vitro testing was conducted to show that Rapid HB, Rapid LB and Rapid MB fulfils the requirements of FDA recognized standard ISO 4823. Additionally, the performance of Rapid HB, Rapid LB and Rapid MB was compared to the predicate devices Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB regarding consistency, contact angle, working time, intraoral setting time, recovery from deformation, strain in compression, detail reproduction, compatibility with gypsum type 3 / type 4 and linear dimensional change. The results of Rapid LB and Rapid MB fulfill the requirements of ISO 4823 and are similar to Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB. In summary, 3M Deutschland GmbH concludes that Rapid HB, Rapid LB and Rapid MB is substantially equivalent to the predicate devices regarding performance and physical and mechanical properties.
Biocompatibility
The biocompatibility assessment for the products was conducted in accordance with the following guidance:
| Guidance | Edition | Title |
|---|---|---|
| US FDA Docket | ||
| Number FDA-2013- | ||
| D-0350. CDRH | ||
| Document Number | ||
| 1811 | June 16, | |
| 2016 | Use of International Standard ISO 10993-1, Biological | |
| evaluation of medical devices - Part 1: Evaluation and testing | ||
| within a risk management process - Guidance for Industry | ||
| and Food and Drug Administration Staff | ||
| ISO 10993-1 | 2009 | Evaluation and testing within a risk management process |
| ISO 10993-5 | 2009 | Tests for in vitro cytotoxicity |
| ISO 10993-10 | 2010 | Tests for irritation and skin sensitization |
| ISO 10993-11 | 2006 | Tests for systemic toxicity |
| ISO 10993-12 | 2012 | Sample preparation and reference materials |
| ISO 10993-18 | 2005 | Chemical characterization of materials |
| ISO 7405 | 2008/Amd 1: | |
| 2013 | Evaluation of biocompatibility of medical devices used in | |
| dentistry |
The biocompatibility of Rapid LB, Rapid LB and Rapid MB has been assessed by a boardcertified toxicologist according to recommendations in FDA quidance and internationally recognized standards for medical and dental devices. The conclusion of the assessment is that Rapid HB, Rapid LB and Rapid MB are safe for their intended use.
Conclusion
Comparisons of the indications for use/intended use, composition, technology, and physical and mechanical properties showed that the Rapid HB, Rapid LB and Rapid MB group of materials is as safe, as effective, and performs as well as or better than the legally marketed devices Impregum Penta Soft Quick Step HB, Impregum Penta Soft Quick Step MB and Impregum Soft Quick Step LB.