← Back to catalogue
JET BLUE BITE FAST 50 ml
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 6491Model Jet Bite510(k) K250969
by Dent4You AG
Identity
- Trade Name
- JET BLUE BITE FAST 50 ml EUDAMED
- Model / Reference
- Jet Bite EUDAMED6491 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630243635757 EUDAMED
- Basic UDI-DI
- 76303929ASIL190313A EUDAMED
- EMDN Code
- Q01020102 DENTAL IMPRESSION VINYLSILOXANS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Silicone dental impression material
JET BLUE BITE FAST 50 ml by Dent4You AG — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Silicone dental impression material.
- Defend — Young Innovations, Inc. · Class II
- UPPER IMPRESSION TRAY (S) — Dental Expert · Class I
- Katalysator Paste 35 ml — DETAX GmbH & Co. KG · Class IIa
- Bonasil A+ Regular (FS) 50ml x 32 — DMP Dental Industry S.A. · Class I
- BISSNEHMEWACHS GELB (weich) — Gebdi Dental-Products GmbH · Class I
- Polysil Multipurpose Regular Set — Scican GmbH · Class II
- PERFECTO — CROWN DELTA CORP. · Class II
- Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250969 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 76303929ASIL190313A | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dent4You AG
- EUDAMED SRN
- CH-MF-000028926
- Authorised Representative
- Dent4you GmbH DE-AR-000006093
Sources (2)
- EUDAMED 88b2716e-1a63-4197-9b58-a9576a1c8709 85 fields · synced Jun 19, 2026
- FDA 510(k) K250969 1 fields · synced May 18, 2026