(246 days)
No
The device description and performance studies focus on the material properties and physical performance of the silicone bite registration material, with no mention of AI or ML.
No
The device is described as an addition-curing silicone for bite registrations which are used to reproduce the patient's occlusal record in dental applications, making it a diagnostic or prosthetic aid rather than a therapeutic device.
No
Explanation:
The device, StoneBite and StoneBite scan, are described as addition-curing silicones for bite registrations, used to produce an accurate reproduction of the patient's occlusal record. This is a material used for physical impression taking. The provided text indicates its purpose is as a material for creating a physical record (a bite registration), not for diagnosing a condition or disease. The performance studies focus on material properties (elastomeric impression material, biocompatibility) rather than diagnostic accuracy.
No
The device description clearly states that StoneBite and StoneBite scan are "addition-curing silicones" and "vinyl polysiloxane based materials," which are physical materials, not software. The performance studies also focus on material properties and biocompatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "bite registrations" and "key for intraoral registration" in dental applications. This involves creating a physical record of the patient's bite, not analyzing a sample from the human body to provide diagnostic information.
- Device Description: The device is described as an "addition-curing silicone" used to "produce an accurate reproduction of the patient's occlusal record." This is a mechanical process for creating a mold or impression.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any substance or characteristic from the human body for the purpose of diagnosis, monitoring, or prognosis.
- Performance Studies: The performance studies focus on material properties (ISO 4823) and biocompatibility (ISO 10993-1, ISO 7405), which are relevant for a dental material, not an IVD.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health status. This device does not fit that description.
N/A
Intended Use / Indications for Use
StoneBite® and StoneBite® scan are addition-curing silicones for bite registrations.
StoneBite® is indicated for:
- bite registrations
- key for intraoral registration
StoneBite® scan is indicated for:
- bite registrations
- key for intraoral registration
- optical collection of data in CAD/CAM/CIM systems
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
StoneBite and StoneBite scan are addition-curing silicones for bite registration, used in dental applications to produce an accurate reproduction of the patient's occlusal record.
Mentions image processing
optical collection of data in CAD/CAM/CIM systems
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)
Non-Clinical Performance Testing: StoneBite and StoneBite scan were tested and met the applicable requirements of the FDA Recognized Consensus standard: ISO 4823:2015 – Dentistry, Elastomeric Impression Material. Bench test results allowed us to conclude that StoneBite and StoneBite scan meet their intended use.
Biocompatibility: StoneBite and StoneBite scan meet biocompatibility requirements of the following standards: ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process; ISO 7405:2008 Dentistry – Evaluation of Biocompatibility of Medical Devices Used in Dentistry.
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.
K171562, K081017, K021410, K053427
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
November 7, 2019
Dreve Dentamid GmbH % Nevine Erian Regulatory Consultant BOC Consulting LLC 24341 Barbados Dr. Dana Point, California 92629
Re: K190571
Trade/Device Name: StoneBite and StoneBite scan Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: July 10, 2019 Received: October 9, 2019
Dear Nevine Erian:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190571
Device Name
StoneBite® and StoneBite® scan
Indications for Use (Describe)
StoneBite® and StoneBite® scan are addition-curing silicones for bite registrations.
StoneBite® is indicated for:
- bite registrations ■
- I key for intraoral registration
StoneBite® scan is indicated for:
- I bite registrations
- key for intraoral registration
- optical collection of data in CAD/CAM/CIM systems ■
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K190571 510(k) Summary
| Submitter | Dreve Dentamid GmbH
Max-Planck-Strasse 31
59423 Unna, Nordrhein-Westfalen, Germany
Establishment Reg. No. 1000486347 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Dr. Reiner Altmann
Head of Quality Management & Regulatory Affairs
Phone +49 2303 8807 14
Fax +49 2303 8807 581
E-Mail reiner.altmann@dreve.de |
| Official Correspondent | Nevine Erian
Regulatory Consultant
BQC Consulting LLC
24341 Barbados Dr.
Dana Point, CA 92629
Phone (949)370-7155
Fax (949) 240-8829
E-mail nevine@bqcconsulting.com |
| Date Prepared | November 5, 2019 |
| Trade/Device Name | StoneBite® and StoneBite® scan |
| Common Name | Impression Materials |
| Classification Name | Impression Material |
| Regulation Number | 21 CFR 872.3660 |
| Product Code | ELW |
Predicate Devices
Futar® (Kettenbach GmbH & Co. KG) – K081120 – Primary Predicate
4
Reference Devices
Dynax® (Dreve Dentamid GmbH) – K171562
Counter-Fit® (Clinician's Choice Dental Products, Inc) - K081017
Aquasil® (Dentsply Intl.) — K021410
Exacta Fresh® (Exacta Dental Products, Inc.) – K053427
Device Description
StoneBite and StoneBite scan are addition-curing silicones for bite registration, used in dental applications to produce an accurate reproduction of the patient's occlusal record.
Statement of Intended Use
StoneBite and StoneBite scan are viny|polysiloxane based materials for biteregistration.
Statement of Indication for Use
StoneBite® and StoneBite® scan are addition-curing silicones for bite registrations.
StoneBite® is indicated for:
- . bite registrations
- I key for intraoral registration
StoneBite® scan is indicated for:
- i bite registrations
- key for intraoral registration
- . optical collection of data in CAD/CAM/CIM systems
Material Composition
StoneBite and StoneBite scan are vinyl polysiloxane based materials.
Technological Characteristics
StoneBite and StoneBite scan are medium-body elastomeric bite registration materials for dental applications to produce an accurate reproduction of the patient's occlusal record. StoneBite and StoneBite scan are two-component (base and catalyst) additioncuring materials.
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Non-Clinical Performance Testing
StoneBite and StoneBite scan were tested and met the applicable requirements of the FDA Recognized Consensus standard:
- 트 ISO 4823:2015 – Dentistry, Elastomeric Impression Material
Bench test results allowed us to conclude that StoneBite and StoneBite scan meet their intended use.
Biocompatibility
StoneBite and StoneBite scan meet biocompatibility requirements of the following standards:
- . ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
- . ISO 7405:2008 Dentistry – Evaluation of Biocompatibility of Medical Devices Used in Dentistry
Dynax® (K171562), Aquasil® (K021410), Counter-Fit® (K081017), and Exacta Fresh® (K053427) are Reference Devices in conjunction with biological testing and literature review to support the biocompatibility of StoneBite and StoneBite scan.
Clinical Performance Data
Not applicable. No human clinical testing was performed to support the substantial equivalence of StoneBite and StoneBite scan.
Substantial Equivalence
The technical characteristics of StoneBite materials are substantially equivalent to the K081120 Primary Predicate device. The Reference Devices, Dynax® (K171562), Aquasil® (K021410), Counter-Fit® (K081017), and Exacta Fresh® (K053427), are only referenced to support the biocompatibility of the subject devices.
Material
StoneBite and StoneBite scan are similar in chemical composition as the predicate devices.
Physical Properties
StoneBite and StoneBite scan have similar physical properties as the predicate devices.
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| Attribute | StoneBite and StoneBite scan | Futar |
|---|---|---|
| Indications | ||
| Bite registration | StoneBite - Yes | |
| StoneBite scan - Yes | Futar D - Yes | |
| Futar Cut & Trim Fast - Yes | ||
| Key for intraoral | ||
| registration | StoneBite - Yes | |
| StoneBite scan - Yes | Futar D - Yes | |
| Futar Cut & Trim Fast - Yes | ||
| Optical collection of data in | ||
| CAD/CAM/CIM systems | StoneBite - No | |
| StoneBite scan - Yes | Futar D - No | |
| Futar Cut & Trim Fast - Yes | ||
| Physical Property | ||
| Type 2 - Medium-body per | ||
| ISO 4823 | StoneBite - Yes | |
| StoneBite scan - Yes | Futar D - Yes | |
| Futar Cut & Trim Fast - Yes | ||
| Working Time | StoneBite - 30 sec | |
| StoneBite scan - 30 sec | Futar D - ≤ 30 sec | |
| Futar Cut & Trim Fast - ≤ 15 sec | ||
| Intraoral Setting Time | StoneBite - ≥ 50 sec | |
| StoneBite scan - ≥ 50 sec | Futar D - ≥ 90 sec | |
| Futar Cut & Trim Fast - ≥ 45 sec | ||
| Linear Dimensional Change | StoneBite - |