Dent4you AG · Class II · Cleared Jun 27, 2025
| K-number | K250969 |
| Device name | JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST |
| Applicant | Dent4you AG |
| Product code | ELW |
| Device class | Class II |
| Decision date | Jun 27, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 872.3660 |
Jet Bite and Jet Blue Bite are two-component impression materials based on vinylpolysiloxanes used to register the occlusion (bite relationship) between the upper and lower jaw. The materials are mixed during application and applied directly to the teeth, then the mandible is moved into central occlusion to create an impression.
Jet Bite and Jet Blue Bite are addition silicone-based impression materials (vinylpolysiloxane) with the same intended use as the predicate device StoneBite and StoneBite scan. Both are Type B impression materials used for occlusal registration.
Performance testing was conducted according to ISO 4823 and the FDA guidance document 'Dental Impression Materials – Performance Criteria for Safety and Performance Based Pathway' issued September 30, 2024. Testing included Linear dimensional change, Compression & Hardness (Shore A).
The subject device and predicate are both addition silicone-based impression materials (vinylpolysiloxane) with identical indications for use in occlusal registration. Performance testing demonstrates conformity to ISO 4823, showing the device is as safe and effective as the predicate device. The materials have the same composition type and clinical application method, establishing technological and functional equivalence.
View the full FDA submission: accessdata.fda.gov