Jet Liquid
by Lang Dental Manufacturing Company, Inc. 3 variants
Ref 1403GK, 1408FR, 1402X6, 1406S, 1404SW, 1408I
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number++D650146Z | Date21 Jan 2022 | StatusActive |
| United States | GUDID listing GUDID | NumberD6501403GK0 | Date20 Sep 2017 | StatusListed |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Temporary dental crown/bridge resin
- Device Name
- Provisional Crown and Bridge Acrylic
- Model / Ref / Catalog
- 1403GK, 1408FR, 1402X6, 1406S, 1404SW, 1408I, 6 X 30 ML
- Primary DI / UDI-DI
- D6501403GK0, D6501408FR0, D6501402X60, D6501406S0, D6501404SW0, D6501408I0
- Basic UDI-DI
- ++D650146Z
- FDA Product Code
- EBG
- EMDN Code
- Q010699 Materials for the preparation of custom-made dental devices - other
- GMDN Term
- Temporary dental crown/bridge resin
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 872.3770
- EU market of registration
- GreeceFranceIrelandSpainSwedenItaly
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 1403GK 1408FR 1402X6 1406S 1404SW 1408I | 6 X 30 ML |
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000003646
- Authorised representative
- MediMark Europe Sarl. FR-AR-000000182
Other devices from Lang Dental Manufacturing Company, Inc.
See all devices from Lang Dental Manufacturing Company, Inc. →
Properties
Other properties (19)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Serial Number: No
- Manufacturing Date: No