JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST

K250969 · Dent4you AG · ELW · Jun 27, 2025 · Dental

Device Facts

• Record ID: K250969
• Device Name: JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST
• Applicant: Dent4you AG
• Product Code: ELW · Dental
• Decision Date: Jun 27, 2025
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Intended Use

JET BITE & JET BLUE BITE are intended for the registration of occlusion in cases where relationship between the relative positions of maxilla and mandible is required.

Device Story

Two-component vinylpolysiloxane (VPS) impression materials; used for occlusal registration. Applied directly to teeth via mixing during application; mandible moved into central occlusion to capture impression. Used in clinical dental settings by dental professionals. Output is a physical dental impression used to record jaw relationship; facilitates clinical decision-making for restorative or prosthetic dental procedures. Benefits include accurate, stable registration of maxilla-mandible relationship.

Clinical Evidence

Bench testing only. Performance testing conducted per FDA guidance 'Dental Impression Materials – Performance Criteria for Safety and Performance Based Pathway' and ISO 4823. Evaluated linear dimensional change, compression set, and Shore A hardness.

Technological Characteristics

Vinylpolysiloxane (addition silicone) impression material. Two-component system. Compliant with ISO 4823 for Type B impression materials. No software or electronic components.

Indications for Use

Indicated for registration of occlusion to determine the relationship between maxilla and mandible positions in dental patients.

Regulatory Classification

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

• StoneBite and StoneBite scan (K190571)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

June 27, 2025

Dent4You AG
Oliver Ashe
Regulatory Affairs Manager
Bahnhofstrasse 2
Heerbrugg, SG 9435
SWITZERLAND

Re: K250969
Trade/Device Name: Jet Bite; Jet Blue Bite Fast; Jet Blue Bite Superfast
Regulation Number: 21 CFR 872.3660
Regulation Name: Impression Material
Regulatory Class: Class II
Product Code: ELW
Dated: March 12, 2025
Received: March 31, 2025

Dear Oliver Ashe:

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

{1}

K250969 - Oliver Ashe
Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

{2}

K250969 - Oliver Ashe
Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

MICHAEL E. ADJODHA -S

Michael E. Adjodha, MChE, RAC, CQIA
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

{3}

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K250969

Device Name
JET BITE;
JET BLUE BITE FAST;
JET BLUE BITE SUPERFAST

Indications for Use (Describe)
JET BITE & JET BLUE BITE are intended for the registration of occlusion in cases where relationship between the relative positions of maxilla and mandible is required.

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
[e-mail]

"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."

{4}

510(k) #: K250969
510(k) Summary
Prepared on: 2025-04-01

| Contact Details | 21 CFR 807.92(a)(1) |
| --- | --- |
| Applicant Name | Dent4You AG |
| Applicant Address | Bahnhofstrasse 2 Heerbrugg SG 9435 Switzerland |
| Applicant Contact Telephone | 41717575424 |
| Applicant Contact | Mr. Oliver Ashe |
| Applicant Contact Email | [e-mail] |
| Device Name | 21 CFR 807.92(a)(2) |
| Device Trade Name | JET BITE;
JET BLUE BITE FAST;
JET BLUE BITE SUPERFAST |
| Common Name | Impression material |
| Classification Name | Material, Impression |
| Regulation Number | 872.3660 |
| Product Code(s) | ELW |
| Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) | |
| Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code | |
| K190571 | StoneBite and StoneBite scan ELW |
| Device Description Summary 21 CFR 807.92(a)(4) | |
| Jet Bite and Jet Blue Bite are two component impression materials based on vinylpolysiloxanes used for the registration of occlusion between the maxilla and mandible. Jet Bite and Jet Blue Bite are mixed during application and applied directly to the teeth, after which the mandible is moved into central occlusion making an impression. | |
| Intended Use/Indications for Use 21 CFR 807.92(a)(5) | |
| JET BITE & JET BLUE BITE are intended for the registration of occlusion in cases where relationship between the relative positions of maxilla and mandible is required. | |
| Indications for Use Comparison 21 CFR 807.92(a)(5) | |
| The indications for use are similar between the subject device and predicate. | |
| Technological Comparison 21 CFR 807.92(a)(6) | |
| JET BITE & JET BLUE BITE (subject device) and StoneBite and StoneBite scan (predicate device) are both addition silicone based impression materials (vinylpolysiloxane), with the same intended use. | |

{5}

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Performance testing was carried out in accordance with the FDA guidance document, "Dental Impression Materials – Performance Criteria for Safety and Performance Based Pathway", issued September 30, 2024. Performance testing in this guidance is based on the FDA recognised version of ISO 4823

As per the requirements set out in FDA guidance document, "Dental Impression Materials – Performance Criteria for Safety and Performance Based Pathway", for a Type B impression material, the following performance tests were carried out on the subject device: Linear dimensional change, Compression set & Hardness (Shore A)

We have carried out testing relevant for Type B impressions materials as set out in "Dental Impression Materials - Performance Criteria for Safety and Performance Based Pathway", we have been able to declare conformity to ISO 4823, therefore demonstrating the device is as safe and effective as the predicate device